• Clinical trial updates for the period of January to October 2023 saw an increase of 4.6% compared to the same time period last year. (bioworld.com)
  • Comparatively, clinical data from January to September 2023 was up 1.79% compared to the same period last year. (bioworld.com)
  • Oxurion NV, which had spent much of 2023 scraping together funding in hopes of a positive readout for its bicyclic peptide, THR-149, in diabetic macular edema (DME), now faces a bankruptcy filing after the drug failed to best established anti-VEGF therapy aflibercept (Regeneron Pharmaceuticals Inc.) in improving vision in part B of the phase II Kalahari study. (bioworld.com)
  • With regard to the clinical safety and efficacy of pitavastatin, the Phase IV Collaborative study of Hypercholesterolemia drug Intervention and their Benefits for Atherosclerosis prevention (CHIBA study) showed similar changes in lipid profile with pitavastatin and atorvastatin in Japanese patients with hypercholesterolemia. (nih.gov)
  • Rationale: We developed a standardized method, possible poor treatment response (PPTR), to help ascertain efficacy endpoints in Study S31/A5349 (NCT02410772), an open-label trial comparing two 4-month rifapentine-based regimens with a standard 6-month regimen for the treatment of pulmonary tuberculosis (TB). (cdc.gov)
  • Conclusions: Standardized methodologies, such as our PPTR approach, could facilitate unbiased efficacy outcome determinations, improve discrimination between outcomes that are related and unrelated to regimen efficacy, and enhance the ability to conduct pooled analyses of contemporary trials. (cdc.gov)
  • In areas without effective treatments, such pathways lead to licensure without rigorous clinical efficacy data. (mcmaster.ca)
  • In China now, the pandemic is basically well-controlled, so at least for now, no one can expect an optimal trial environment for the efficacy study,' said a spokesperson for the Chinese biotech company Walvax, currently in the phase 1 stage of testing. (go.com)
  • The research and development of a new drug is a logical, stepwise process in which data is collected from small clinical studies involving a human research participant population to support and guide long-term safety and efficacy trials that will eventually allow the registration and marketing of a new therapeutic tool. (powershow.com)
  • Conclusions: Losmapimod was well tolerated with no SAEs reported and achieved dose-dependent exposure in plasma and muscle at concentrations predicted by pre-clinical models demonstrating efficacy by reducing DUX4 activity. (mdaconference.org)
  • With these approaches, we investigate adverse effects, safety and efficacy of MS immunotherapies, potential predictors of treatment effects and disease course, modifiers of the disease course, e.g. vitamin D, and of course current topics such as the COVID pandemic in relation to MS. In addition, we clinically and preclinically investigate one of the "novel" disease entities - MOG-IgG-associated disorders (MOG-AD) - in particular. (unibe.ch)
  • The Phase 2 segment includes expansion of the number of patients to approximately 90 patients treated on the five day subcutaneous dosing schedule to better evaluate both efficacy and safety in MDS and AML patients. (technologynetworks.com)
  • The allowance of treatment-naive MDS and elderly AML patients will be important in evaluating efficacy and safety of SGI-110 in this patient population and to further characterize the clinical differentiation of the drug," said Mohammad Azab, MD, chief medical officer. (technologynetworks.com)
  • Trending Clinical Topic: Semaglutide - Medscape - Jul 09, 2021. (medscape.com)
  • 2021 Feb 16;72(4):682-685. (cdc.gov)
  • In a statement, the NIH said the first phase 2 trials will evaluate at least four treatments, part of its ongoing RECOVER (Researching COVID to Enhance Recovery) initiative, a $1.5 billion effort that was included in the American Rescue Plan Act of 2021. (umn.edu)
  • On May 5, 2021, CDC's Tuberculosis Trials Consortium and the National Institutes of Health (NIH)-sponsored AIDS Clinical Trials Group (ACTG) published results from a randomized controlled trial indicating that a 4-month regimen containing rifapentine (RPT), moxifloxacin (MOX), isoniazid (INH), and pyrazinamide (PZA) was as effective as the standard 6-month regimen for tuberculosis (TB) treatment ( 1 ). (cdc.gov)
  • But those trials are now back up and running and may have data available in early 2021. (go.com)
  • CDC developed this interim guidance, based on evidence from Study 31/A5349, preclinical and animal evidence, previous clinical trial findings, pharmacokinetic and pharmacodynamic modeling ( 1 , 3 - 6 ), and CDC expert opinion regarding considerations for implementation of the new 4-month daily treatment regimen in the United States. (cdc.gov)
  • Researchers conduct clinical trials in a series of steps called phases. (nih.gov)
  • Political instability in Ukraine has not diminished international drug industry desire to conduct clinical trials there according to a new report. (outsourcing-pharma.com)
  • In addition to the information on expanded access programs, the PhRMA chapter also outlines ways for companies to protect research participants, properly conduct clinical trials, ensure objectivity in research, and ways to provide more information about clinical trials. (outsourcing-pharma.com)
  • On Aug. 4, 2020 , NIAID announced the launch of ACTIV-2, which initially tested LY-CoV555, a monoclonal antibody made by Eli Lilly and Company. (nih.gov)
  • The first patient enrolled in Pfizer's COVID-19 coronavirus vaccine clinical trial at the University of Maryland School of Medicine in Baltimore, receives an injection, May 4, 2020. (go.com)
  • The first of four experimental COVID-19 vaccines being tested by Pfizer and its German partner BioNTech showed encouraging results in very early testing of 45 people, the companies said Wednesday, July 1, 2020. (go.com)
  • A scientist checks quality control of vaccine vials for correct volume at the Clinical Biomanufacturing Facility (CBF) in Oxford, Britain, April 2, 2020. (go.com)
  • A little-known fact of the pharmaceutical business is that it increasingly has used Eastern European nations, and Russia and Ukraine in particular, for later phase clinical trials. (healthydebate.ca)
  • Most (75%) were pharmaceutical highly likely applicable clinical trials and 71% were industry-funded. (nih.gov)
  • A reversal of the government's stance would offer another cost-cutting route for pharmaceutical companies and further swell India's blossoming clinical trials industry. (blogspot.com)
  • According to the World Health Organization, only one candidate -- the U.K.'s University of Oxford, which is partnering with the pharmaceutical company AstraZeneca -- has officially launched a phase 3 trial. (go.com)
  • Geneva, Switzerland, September 4, 2018 SGS, a leading life sciences, pharmaceutical, clinical and bioanalytical contract solutions provider, today announced that it has successfully implemented advanced techniques for the collection and use of peripheral blood mononuclear cells (PBMCs) for early phase clinical trials at its Clinical Pharmacology Unit (CPU) in Antwerp, Belgium, and is also further strengthening its offer in the areas of infectious disease therapeutics and vaccines. (appliedclinicaltrialsonline.com)
  • Under the chapter, industry group PhRMA (Pharmaceutical Researchers and Manufacturers of America) notes that physicians can apply for expanded access to an unapproved drug for their patients to treat a serious or life-threatening disease or condition when there are no other comparable or satisfactory alternative treatment options and when patients are ineligible or unable to participate in a clinical trial. (outsourcing-pharma.com)
  • In phase II studies of targeted agents, multiple- versus single-institution participation, positive phase II trial, pharmaceutical company-based trials, and shorter time period between publication of phase II to phase III trial were independent predictive factors of success in a phase III trial. (typeset.io)
  • Fulcrum Therapeutics, 4. (mdaconference.org)
  • Demand in the biopharmaceutical industry for R&D in immunology and oncology therapeutics continues to grow, with additional parameters now required for clinical trials beyond traditional pharmacokinetic (PK) and pharmacodynamic (PD) parameters. (appliedclinicaltrialsonline.com)
  • Kaufman has been collaborating with Fate Therapeutics over the past four years to bring iPSC-derived NK cells to patients with cancer. (ucsd.edu)
  • Last week, a new chapter of PhRMA's Principles on the Conduct of Clinical Trials and Communication of Clinical Trial Results went into effect, detailing efforts to raise awareness around expanded access programs, which provide investigational drugs for certain patients who are ineligible or unable to participate in a clinical trial. (outsourcing-pharma.com)
  • Clinical trials are an important part of the research spectrum. (nih.gov)
  • Clinical trials follow a protocol, a carefully designed plan to safeguard your health and answer specific research questions. (nih.gov)
  • The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications for the NIAID Atopic Dermatitis Research Network Clinical Research Centers (ADRN-CRCs). (nih.gov)
  • The ADRN-CRCs will conduct the ADRN network-wide clinical research projects under the leadership of the ADRN Leadership Center (ADRN-LC). (nih.gov)
  • In parallel, each ADRN-CRC will pursue its own clinical research program in support of the scientific goals of the ADRN. (nih.gov)
  • The NLM National Information Center on Health Services Research and Health Care Technology (NICHSR) is responsible for developing information services for the research and library communities involved in health services research and for coordinating clinical terminology and health data standards within the Department of Health and Human Services. (nih.gov)
  • This FOA issued by the National Institute on Aging encourages Clinical Trial Planning Grant (R34) applications to develop research protocols for Phase III and IV clinical trials related to critical illness and injury in aging. (nih.gov)
  • The planning grant mechanism is intended to permit early peer review of the rationale and design of the proposed Phase III or IV clinical trial, and to support development of a research team, tools for data management and research oversight, recruitment strategies, detailed protocol and Manual of Procedures (MOP), and other essential components necessary for a competitive clinical trial application. (nih.gov)
  • This FOA will utilize the Clinical Trial Planning Grant (R34) mechanism and runs in parallel with PA-10-042 , that encourages applications under the R01 Research Project grant mechanism, PA-10-043 , that encourages applications under the R03 Small Research Grant mechanism, and PA-10-044 , that encourages applications under the R21 Exploratory/Developmental grant mechanism. (nih.gov)
  • These Stage 3 clinical trials are critical to take a drug from the research bench to the bedside. (healthydebate.ca)
  • Research investigators in Ukraine are highly motivated and trusted by their patients, leading to low dropout rates and high recruitment, Vlad Bogin, founder of Cromos Pharma, a contract research organization with clinical trials in Ukraine and Russia told the Journal of the American Medical Association. (healthydebate.ca)
  • Clinical trial monitoring requires data collection and analysis throughout a project to ensure appropriateness of the research and project design, validity and integrity of the data, and protection of human subjects. (nih.gov)
  • and clinical research of any type involving more than minimal risk to volunteers. (nih.gov)
  • Applicants, grantees, and staff all have responsibilities for monitoring clinical research. (nih.gov)
  • Domestically conducted clinical research supported by NIAID must comply with U.S. state and local regulations. (nih.gov)
  • Clinical research continues to expand within nuclear medicine and molecular imaging departments. (snmjournals.org)
  • The details of working in clinical research are often not taught in nuclear medicine technologist programs. (snmjournals.org)
  • As such, there is an emerging need for education about clinical research for both experienced and new nuclear medicine technologists, particularly for those working with investigational radiopharmaceuticals. (snmjournals.org)
  • This article is an introduction to the SNMMI Clinical Trials Network Research Series for Technologists. (snmjournals.org)
  • An important goal for this series of articles is to provide clinical research education to nuclear medicine technologists and information to those in our community interested in the use of molecular imaging as a biomarker and in the development, regulatory, and approval process for new, investigational molecular imaging diagnostic and therapeutic radiopharmaceuticals. (snmjournals.org)
  • Finally, the CTN develops educational programs for live meetings, webinars, and online courses, including imaging interpretation training sessions that help nuclear medicine professionals learn about working in clinical research and about translating clinical trial experience into the clinical implementation of new tracers and radiopharmaceutical therapies after approval ( 5 ). (snmjournals.org)
  • Phase 4 research: what happens when the rubber meets the road? (mcmaster.ca)
  • However, the appearance of rare but serious side effects in patients taking approved drugs has led to increased attention to phase 4, or postmarketing, research. (mcmaster.ca)
  • If you are giving a presentation about an environmental health topic or just looking for general information about environmental health research or the institute, this page will help. (nih.gov)
  • Currently Phase I trials are only allowed if the compound was discovered in India or if data from other markets is submitted, which has restricted the outsourcing of early stage research to India. (blogspot.com)
  • Analysis by the Moscow, Russia ​-based contractor Synergy Research Group reveals that 108 of the 155 trials approved in Ukraine in the first half of 2014 were part of multinational, multi-centre clinical trials (MMCT), which is up from the 93 approved last year. (outsourcing-pharma.com)
  • The study also lists Icon, Parexel and INC research among the most active clinical trial applicants in 2013. (outsourcing-pharma.com)
  • However, as the region is now controlled by Russia, contract research organisations (CROs) and sponsors seeking to conduct trials there have been able to ask Moscow authorities for the right to conduct studies, provided the sites were already approved by the Ministry of Health. (outsourcing-pharma.com)
  • For the approval of the regulatory authorities, clinicians and research investigators should understand the real nature of PCs and PC therapy (i.e., adjuvant therapy), standardize protocols of preparation (e.g., choice of centrifuges and tubes) and clinical application (e.g., evaluation of recipient conditions), design bias-minimized randomized clinical trials, and recognize superfluous brand competitions that delay sound progress. (mdpi.com)
  • What is Clinical Research? (powershow.com)
  • Clinical health care research is a systematic investigation intended to produce scientific and clinical knowledge for understanding disease, preventing and treating illness. (powershow.com)
  • Clinical research may improve existing technologies and produce new medicines for future patients. (powershow.com)
  • Clinical Research Career Development programs of the NIH help maintain a cadre of biomedical researchers in the US. (powershow.com)
  • These grant programs are designed to attract talented medical students, physicians, dentists, and similar professionals to the challenges of clinical research or to help clinical investigators transition to independent research careers. (powershow.com)
  • Clinical trials are research studies that involve people. (moreinfo.info)
  • Enjoyed this Research Topic? (frontiersin.org)
  • The aim of this Research Topic is to build on the current research on the topic of personalized medicine in HCC and to detail future promises it can offer. (frontiersin.org)
  • The scope of the Research Topic is to study the molecular pathways of HCC and the drugs that affect those pathways. (frontiersin.org)
  • Our research is dedicated to the investigation of neuroimmunological disorders of the central nervous system (CNS) combining clinical and translational neuroscience. (unibe.ch)
  • Our clinical, research and study team luckily consists of highly enthusiastic colleagues from different backgrounds, being clinicians, nurses, study coordinators (with a background in biology and pharmacy) and basic researchers offering a broad basis of expertise. (unibe.ch)
  • SGS provides clinical research and bioanalytical testing with a specific focus on early stage development and biometrics. (appliedclinicaltrialsonline.com)
  • New, innovative clinical trial technology is helping to revolutionize the research landscape. (outsourcing-pharma.com)
  • Interim Phase 1 clinical data from subcutaneous SGI-110 was previously reported at the American Association for Cancer Research (AACR) 2012 Annual Meeting in Chicago, IL. (technologynetworks.com)
  • The IPF-PRO Registry is an academic-industry alliance between Boehringer Ingelheim Pharmaceuticals, Inc. and the Duke Clinical Research Institute to better understand outcomes and disease progression for people with IPF, a rare and fatal lung disease. (prnewswire.com)
  • Over time, we look forward to helping the IPF community learn more about disease progression, quality of life and other outcomes that are important to patients," said lead study author Michael Durheim , M.D., Medical Instructor, Department of Medicine, Duke Clinical Research Institute. (prnewswire.com)
  • These results showed us that many patients already have significant respiratory impairment by the time they are diagnosed by a pulmonologist, which reinforces what we know from ongoing research," said Danny McBryan , M.D., vice president, Clinical Development and Medical Affairs, Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc. "The Registry emphasizes the critical need to recognize IPF earlier and send patients to a specialist faster to determine diagnosis and care. (prnewswire.com)
  • The off-the-shelf, iPSC-derived natural killer (NK) cell cancer immunotherapy received U.S. Food and Drug Administration approval to move into clinical trials in November 2018. (ucsd.edu)
  • Diagnostic trials study or compare tests or procedures for diagnosing a particular disease or condition. (nih.gov)
  • A phase 1 study recently found that use of semaglutide (2.4 mg) with an investigational agent, cagrilintide, resulted in greater weight loss than semaglutide alone and was well tolerated (see Infographic below). (medscape.com)
  • DDF Clinical Study Attribute A terminology value set relevant to the attributes of the clinical study. (nih.gov)
  • The CTN also audits investigational radiopharmaceuticals produced for clinical trials under investigational-new-drug applications to help ensure the safety, consistency, and purity of the drugs being administered to study patients, as well as assisting with trial design and protocol development for molecular imaging and radiopharmaceutical therapy clinical trials. (snmjournals.org)
  • The new agents entering the randomized, placebo-controlled study are part of ACTIV-2 , an adaptive trial designed to test investigational agents in non-hospitalized adult volunteers experiencing mild to moderate COVID-19 symptoms. (nih.gov)
  • If an investigational agent shows promise by demonstrating safety and reducing COVD-19 symptoms through 28 days following administration, the ACTIV-2 trial is designed to expand seamlessly from a Phase 2 to a Phase 3 study to gather additional critical data from a larger pool of volunteers without delay. (nih.gov)
  • For more information on this study, please visit www.riseabovecovid.org , or visit ClinicalTrials.gov and search identifier NCT04518410 . (nih.gov)
  • Approximately 15% of highly likely applicable clinical trials reported results within 1 year of trial completion, while 55% reported results over the 5-year study period. (nih.gov)
  • For the study , researchers from Rutgers University and the University of Pittsburgh analyzed consecutive patients with blood cultures positive for Staphylococcus species over three independent 4-month periods. (umn.edu)
  • The BLA is supported by the pivotal phase III Atomic study in which pegargiminase (pegylated arginine deiminase/ADI-PEG 20) met the primary endpoint of a statistically significant improvement in overall survival and the secondary endpoint of a significant improvement in progression-free survival in patients with malignant pleural mesothelioma. (bioworld.com)
  • Surmodics Inc. reported positive two-year data from the SWING trial, the first-in-human study to look at the safety of its Sundance Sirolimus drug-coated balloon (DCB) when used to treat occlusive disease of the infrapopliteal arteries. (bioworld.com)
  • When it comes to efficient clinical study build, content is king. (outsourcing-pharma.com)
  • Deviation from intention to treat analysis in randomised trials and treatment effect estimates: meta-epidemiological study. (jameslindlibrary.org)
  • Phase 2 trials study have the treatment effects the body, and how the treatment works for a certain type of cancer. (moreinfo.info)
  • Blinding, blinded trial - a type of study in which the patients (single-blinded) or the patients and their doctors (double-blinded) do not know which drug or treatment is being given. (nascic.org)
  • Sponsored by CDC and conducted in collaboration with the NIH-sponsored ACTG, Study 31/A5349 ( https://clinicaltrials.gov/ct2/show/NCT02410772 external icon ) was an international, open label, phase 3 noninferiority clinical trial that randomized 2,516 participants at 34 clinical sites in 13 countries. (cdc.gov)
  • For our clinical trials (investigator-initiated, phase 2 to 4), we are supported by our Neuroimmunological Study Center (NIS). (unibe.ch)
  • PBMCs are already widely used to study various aspects of pathology and biology in vitro, but are now also more and more used in clinical studies in immunology (including auto-immune disorders), as well as infectious diseases, hematological malignancies, vaccine development and transplant immunology. (appliedclinicaltrialsonline.com)
  • The Phase 1 open-label extension (OLE) study was designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and exploratory functional effects of weekly suvodirsen for 96 weeks. (mdaconference.org)
  • Objectives: To report the analysis of safety, tolerability, and dystrophin levels from baseline to 12 or 22 weeks in the Phase 1 OLE study of suvodirsen. (mdaconference.org)
  • Approach: The interim analysis was from a global multicenter OLE study of suvodirsen in patients who previously enrolled in a Phase 1 study. (mdaconference.org)
  • The FT500 clinical trial is a two-arm study with up to 64 patients for the treatment of advanced solid tumors. (ucsd.edu)
  • Recently a biotech approached Cytel for support with a Phase 2 Study in oncology. (cytel.com)
  • SummaryIn the context of clinical trials where one of several doses or treatments is selected in a phase II study to be examined further in a phase III study, we develop a formulation for the combination of the overall information obtained from such studies, which mimics the logic followed in actual drug development. (typeset.io)
  • What is the respective time period for completion of phase 1 of clinical trials study? (typeset.io)
  • The good news from the meeting is that Biovest will be working directly with the FDA to develop the registration trial design for the study and that meeting is expected to take place in the coming months. (lymphomainfo.net)
  • Roche announced positive results from a Phase II study of trastuzumab -DM1 (T-DM1). (bionity.com)
  • In this single-arm study, 45 percent of women experienced a clinical benefit (defined as a complete or partial tumour response, or stable disease, maintained for at least six months), as assessed by independent review. (bionity.com)
  • This year, Genentech and Roche initiated a Phase III study (EMILIA) evaluating T-DM1 in women with advanced HER2-positive breast cancer whose disease has progressed after receiving initial treatment. (bionity.com)
  • We are interested in expanding our armamentarium of immune cell types we target in solid tumors, which to date have mainly been T-cell directed therapies, and expanding to other cell types, such as natural killer cells, which may have unique advantages in treating certain cancer types," said Patel, who specializes in cancer immunotherapy and early phase clinical trials. (ucsd.edu)
  • Undifferentiated Prostate Cancer and the Neuroendocrine Phenotype -- Part V. Clinical Management Aspects -- 22. (nshealth.ca)
  • Further, new disease entities have recently been characterized by specific antibodies such as Anti-NMDA- and other autoimmune encephalitides and lastly also Anti-GFAP-astrocytopathy, highlighting the need for a well-structured cohort including clinical and paraclinical phenotype description. (unibe.ch)
  • ACTIV-2 is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), one of the National Institutes of Health, and is led by the NIAID-funded AIDS Clinical Trials Group (ACTG). (nih.gov)
  • Pulmicort Flexhaler in 90- & 180-mcg will be phased in by AstraZeneca. (primeinc.org)
  • How patients are enrolled in clinical trials? (typeset.io)
  • After researchers test new treatments or procedures in the lab and in animals, the most promising treatments are moved into clinical trials. (nih.gov)
  • As studies about new treatments move through a series of steps called phases, researchers learn more information about the treatment, its risks, and its effectiveness. (nih.gov)
  • Treatment trials test new treatments, new combinations of medicines, or new approaches to surgery or radiation therapy. (nih.gov)
  • The Russian invasion has upended hundreds of clinical trials and interrupted the delivery of disease-fighting and life-saving treatments. (healthydebate.ca)
  • The National Institutes of Health (NIH) today announced the launch of a series of phase 2 clinical trials to assess clinical treatments for long COVID, part of a plan to test even more treatments in the months ahead. (umn.edu)
  • To examine treatments for autonomic system problems, the initial trial will focus on postural orthostatic tachycardia syndrome, which manifests as irregular heartbeat, dizziness, and fatigue. (umn.edu)
  • As part of our mission to eliminate cancer, MD Anderson researchers conduct hundreds of clinical trials to test new treatments for both common and rare cancers. (mdanderson.org)
  • Phase I-II Targeted Treatments -- 14. (nshealth.ca)
  • Most clinical trials to test new cancer treatments are done in a series of steps, called phases. (moreinfo.info)
  • SGS's Clinical Pharmacology Director, Annick van Riel, continued, "Our expertise in using this technique, combined with our ability to manage such a sensitive parameter in our early phase clinical operations, complete the infectious diseases and vaccines service offer that we have built up over many years, including our CPU human challenge unit. (appliedclinicaltrialsonline.com)
  • SGS has its own Clinical Pharmacology Unit in Belgium, including a human challenge testing facility and two phase I patient units based in Belgium and Hungary. (appliedclinicaltrialsonline.com)
  • Bayer AG's asundexian, considered one of the next generation class of anticoagulants and a potential blockbuster, has failed a phase III clinical trial in atrial fibrillation. (bioworld.com)
  • Design Individual patient level meta-analysis of randomised controlled trials. (bmj.com)
  • The regimen is intended for administration in settings where mycobacterial cultures, molecular and phenotypic drug susceptibility testing (DST), radiographic studies and other diagnostic tools, infrastructure for adverse event monitoring, patient-centered clinical care, and coordination with public health for case management are available. (cdc.gov)
  • Enrolment in the Phase 2 segment is currently open, and the first patient has been dosed. (technologynetworks.com)
  • A file photo provided by the University of Maryland School of Medicine, shows the first patient enrolled in Pfizer's COVID-19 coronavirus vaccine clinical trial at the University of Maryland School of Medicine in Baltimore. (go.com)
  • In February 2019, as part of a phase I clinical trial at Moores Cancer Center at UC San Diego Health, Ruff became the first patient in the world to be treated for cancer with a human-induced pluripotent stem cell (iPSC)-derived cell therapy called FT500. (ucsd.edu)
  • The new data are part of the second cohort of the Phase 1b/2a NABUCCO ( N eo- A djuvant B ladder U rothelial C arcinoma CO mbination-immunotherapy) trial, which investigated patient responses to neoadjuvant treatment with a CTLA-4 inhibitor (ipilimumab) in combination with a PDL1 inhibitor (nivolumab) among patients with locoregionally-advanced urothelial cancer. (accesswire.com)
  • This FOA is NOT designed for collecting preliminary data or conducting pilot studies in support of the scientific rationale for a clinical trial. (nih.gov)
  • also refer to the see Human Subjects topic on Rules and Policies: Special Considerations and Data and Safety Monitoring Boards (DSMB) SOP . (nih.gov)
  • phase III and IV clinical trials generally require an independent data and safety monitoring board (DSMB). (nih.gov)
  • Nuclear medicine technologists involved in clinical trials can be at the front line of following rigorous trial requirements and ensuring good-quality data. (snmjournals.org)
  • To ensure that the trial is being conducted in a safe and effective manner, an independent data and safety monitoring board oversees the trial and periodically reviews the accumulating data. (nih.gov)
  • Continued approval is frequently made contingent on the availability of postmarketing surveillance data demonstrating improvements in clinical end points and these data can also be used to monitor for unexpected toxicity. (mcmaster.ca)
  • One-year data from Xeltis AG's first-in-human Axess vascular conduit trial showed outstanding results in patients with end stage renal disease who were deemed unsuitable for arteriovenous (AV) fistula creation. (bioworld.com)
  • Reporters who had attended the press briefing on the trial data and wrote more accurately were left scratching their heads at how their colleagues could have gotten the story so wrong. (alzforum.org)
  • If they intend to run several different analyses with the trial data, the appropriate way is to pre-specify that, and then ensure the total "alpha" for all those analyses adds up to that 5 percent. (alzforum.org)
  • We will also assess human trial data on personalized medicine treatment of HCC. (frontiersin.org)
  • The data showed that SGI-110 has a clear pharmacokinetic differentiation from Dacogen® (decitabine) for Injection given as an IV infusion. (technologynetworks.com)
  • In a promising development, an initial glimpse at the data from Pfizer's ongoing late-stage clinical trial shows that the company's vaccine is more effective at preventing COVID-19 than placebo. (go.com)
  • Morphosys AG's rare blood cancer treatment hit its phase III primary endpoint but missed statistical significance on a secondary endpoint, sinking the stock for the day. (bioworld.com)
  • INGELHEIM, DE & INDIANAPOLIS, US - The DINAMO Phase III clinical trial met its primary endpoint by demonstrating a statistically significant reduction in HbA1c (a marker of average blood sugar) with empagliflozin compared with placebo for children and adolescents aged 10-17 years living with type 2 diabetes. (lifesciencesbc.ca)
  • National Institutes of Health (NIH) Institutes and Centers, including the NHLBI, support many types of clinical trials that contribute to medical knowledge and practice. (nih.gov)
  • The National Cancer Advisory Board (NCAB) convened for its 126th regular meeting on Tuesday, June 10, 2003, in Conference Room 10 of Building 31, National Institutes of Health (NIH), Bethesda, MD. The meeting was open to the public on Tuesday, June 10, 2003, from 8:30 a.m. to 4:10 p.m. (nih.gov)
  • The Society of Nuclear Medicine and Molecular Imaging (SNMMI) created the Clinical Trials Network (CTN) in 2008 to advance the use of molecular imaging and therapeutic radiopharmaceuticals in clinical trials. (snmjournals.org)
  • Through the work of its committees (a database committee, a committee that validates scanners and qualifies sites, an education committee, a gallium users group/committee for access to nonproprietary radiopharmaceuticals, and a radiopharmaceutical manufacturers committee), the CTN fulfills its mission of facilitating the effective use of diagnostic and therapeutic molecular imaging and radiopharmaceuticals in clinical trials in many ways. (snmjournals.org)
  • Introduction-Castration Resistant Prostate Cancer: A Rapidly Expanding Clinical State and a Model for New Therapeutic Opportunities -- 2. (nshealth.ca)
  • Biovest, makers of the therapeutic lymphoma vaccine BiovaxID®, had a formal clinical guidance meeting with US drug regulators at the FDA yesterday. (lymphomainfo.net)
  • Results from a clinical trial led by MD Anderson researchers showed that combining the immunotherapy checkpoint inhibitor drug durvalumab with chemotherapy has a tolerable safety profile and achieved a clinical response in the majority of patients with newly diagnosed, advanced stage, high grade serous ovarian cancer. (mdanderson.org)
  • Today's results from the DINAMO global clinical trial demonstrated that the SGLT2 inhibitor empagliflozin compared with placebo significantly improved overall blood sugar control in children and adolescents with type 2 diabetes. (lifesciencesbc.ca)
  • A highly effective inhibitor PLX4032 is already under investigation in a Phase 3 clinical trial in melanoma and these results suggest that trials of PLX4032 in MM in targeted individuals would be promising. (bioinf.org)
  • In fact, Moderna has announced it will begin a phase 3 trial on 30,000 participants within the U.S., beginning this July. (go.com)
  • An early morning release said the vaccine from Pfizer and partner Biotech was 'found to be more than 90% effective in preventing COVID-19' according to an early analysis that included 94 confirmed cases of COVID-19 in trial participants. (go.com)
  • Clinical trials are medical studies that involve people like you. (nih.gov)
  • When Russia launched its invasion in February, there were 597 trials under way or actively recruiting in Ukraine, according to ClinicalTrials.gov, the global database of public and private funded studies. (healthydebate.ca)
  • This concept includes phase IV studies conducted in both the U.S. and in other countries. (bvsalud.org)
  • One way is by maintaining a searchable database of molecular imaging and radiopharmaceutical production sites to assist clinical trial sponsors with site selection for their studies. (snmjournals.org)
  • The first AVAREF joint review was for a clinical trial application of phase II and II-III studies of a conjugate meningitis A vaccine, produced by the Serum Institute of India. (who.int)
  • Phase 2 studies in ACTIV-2 enroll up to 220 volunteers, while exact enrollment size of Phase 3 studies will vary depending on mode of administration of the investigational agent. (nih.gov)
  • Now, companies from the U.K., China , South Korea and Germany -- countries where the pandemic is relatively under control -- are looking for new places to start their phase 3 studies. (go.com)
  • With the pandemic still spreading in the United States, American companies may not need to look abroad for their phase 3 studies. (go.com)
  • On May 12, the Ukrainian Minister of Health said no new clinical trials would be approved in either Crimea or Sevastopol and that all ongoing studies should halt recruitment. (outsourcing-pharma.com)
  • This phase I trial studies the side effects and best dose of ganetespib when given with paclitaxel and trastuzumab in treating patients with advanced or metastatic human epidermal growth factor receptor 2 positive (HER2+) breast cancer. (her2support.org)
  • Accelerated approval - an approval pathway in the U.S. for drugs intended to treat serious conditions that have no approved alternatives, in which drugs can be approved after only Phase I or Phase II studies if the studies show the drug is safe and reasonably likely to be effective. (nascic.org)
  • Analysis of Phase II Studies on Targeted Agents and Subsequent Phase III Trials: What Are the Predictors for Success? (typeset.io)
  • Welcome, health care professional, to PRIME's Clinical Case Studies. (primeinc.org)
  • Comparatively, phase 3 trials are a lot more difficult, requiring thousands of volunteers to gauge whether the vaccine works in the real world. (go.com)
  • Prior to the war, more than 60 per cent of the clinical trials in Ukraine involved oncology patients. (healthydebate.ca)
  • Prior to the war, more than 60 per cent of the clinical trials in Ukraine involved oncology patients, especially those with lung cancer, followed by central nervous system disorders, infectious disease, gastroenterology and cardiovascular diseases. (healthydebate.ca)
  • Stopping a trial early in oncology: for patients or for industry? (jameslindlibrary.org)
  • False-positive findings in Cochrane meta-analyses with and without application of trial sequential analysis: an empirical review. (jameslindlibrary.org)
  • Modified versus standard intention-to-treat reporting: Are there differences in methodological quality, sponsorship, and findings in randomised trials? (jameslindlibrary.org)
  • On the basis of these findings, CDC recommends the 4-month regimen as a treatment option for U.S. patients aged ≥12 years with drug-susceptible pulmonary TB and provides implementation considerations for this treatment regimen. (cdc.gov)
  • The findings from the NABUCCO trial offer initial evidence in hopefully improving the outlook for these patients. (accesswire.com)
  • The FDA is requiring Biovest to conduct a confirmatory Phase III clinical trial , meant to support the findings from the Phase III BiovaxID trial BV301. (lymphomainfo.net)
  • Children as well as adults, patients and healthy volunteers, and people of a diverse range of ethnic and racial backgrounds can and are encouraged to participate in clinical trials. (nih.gov)
  • Phase 3 includes volunteers from different regions and countries prior to approval by regulatory bodies. (healthydebate.ca)
  • The first two trials are typically smaller ones, testing mostly for vaccine safety and biological activity, requiring from 50 to hundreds of volunteers respectively. (go.com)
  • Moderna has enrolled all 30,000 volunteers needed for its late-stage trial, and expects to have its first interim analysis this month too. (go.com)
  • In which phase of clinical trials healthy volunteers are enrolled? (typeset.io)
  • Here is the bottom line on this trial: The drug missed its co-primary endpoints of slowing cognitive and functional decline in mild to moderate Alzheimer's disease, as measured by the ADAS-cog and ADCS-ADL batteries. (alzforum.org)
  • Defining Clinical Endpoints in Castration-Resistant Prostate Cancer -- Part IV. (nshealth.ca)
  • Trials will launch and enroll patients on a rolling basis at clinical sites throughout the United States, the NIH said. (umn.edu)
  • Most vaccine phase 3 trials need to enroll tens of thousands of patients. (go.com)
  • The industry group lays out a number of considerations for biopharma companies to follow when providing patients with access to an unapproved investigational drug outside of a clinical trial. (outsourcing-pharma.com)
  • A recent clinical trial identified a daily 4-month regimen that is as effective as the standard daily 6-month regimen in curing drug-susceptible tuberculosis. (cdc.gov)
  • However, a rise in the rate of recurrence (e.g., in tendon and ligament injuries) and adverse (or nonsignificant) clinical outcomes associated with PC therapy have raised fundamental questions regarding the validity of the therapy. (mdpi.com)
  • Bias due to selective inclusion and reporting of outcomes and analyses in systematic reviews of randomised trials of healthcare interventions. (jameslindlibrary.org)
  • Having overcome the challenges in recruitment and design that pediatric trials tend to face, the outcomes of DINAMO represent another positive step forward in Boehringer Ingelheim and Lilly's commitment to improve the lives of people living with cardio-renal and metabolic conditions such as type 2 diabetes. (lifesciencesbc.ca)
  • Phase four, is post-approval, longer-term safety screening. (healthydebate.ca)
  • Johnson -- had brief setbacks when their late-stage trials were paused over safety concerns. (go.com)
  • The clinically meaningful benefit and consistent safety profile demonstrated with empagliflozin in the DINAMO trial is an encouraging outcome for the vulnerable population of children and adolescents. (lifesciencesbc.ca)
  • Part I. Castrate-Resistant Prostate Cancer: Clinical and Biological Considerations -- 1. (nshealth.ca)
  • This interim guidance updates 2016 guidelines by recommending and providing implementation considerations for a novel 4-month daily treatment regimen, based on high-dose daily RPT with MOX, INH, and PZA ( 1 ) as a treatment option for U.S. patients aged ≥12 years with drug-susceptible pulmonary TB. (cdc.gov)
  • The clinical trial was sponsored by PATH/MVP (Meningitis Vaccine Project). (who.int)
  • Vaccine trials usually undergo three rounds of testing: phase 1, phase 2 and phase 3. (go.com)
  • The company plans to submit for FDA authorization in the third week of November.From there, it could take the FDA two to four weeks to make an authorization decision after a public hearing and a recommendation from an independent vaccine advisory committee. (go.com)
  • Each phase has a different purpose and helps researchers answer different questions. (nih.gov)
  • Researchers must take these potential errors into account, otherwise clinical trial results could be meaningless. (alzforum.org)
  • Meanwhile, most large firms have said they will no longer use Russia for their trials but will continue to supply drugs to its health-care system. (healthydebate.ca)
  • The outsourcing of Phase I trials to India may be allowed by 2009-10 after the Central Drugs Standard Control Organisation (CDSCO) said it is considering changing its stance. (blogspot.com)
  • Breakthrough Therapy Designation - a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s). (nascic.org)
  • The UP-NEXT trial aims to enrol 350 patients, specifically those whose ovarian cancer has returned following treatment with platinum-based chemotherapy drugs, such as cisplatin, carboplatin and oxaliplatin. (pharmafocus.com)
  • Other topics may be added over the course of the development of the series. (snmjournals.org)
  • Both countries had participated in a workshop in Addis Ababa, Ethiopia, in September 2005 which resulted in the development of regulatory procedures for submission and review of clinical trial applications, and for the importation and release of clinical batches. (who.int)
  • Seltorexant is under development for treatment of major depressive disorder however and is in phase 3 trials for this indication. (wikipedia.org)
  • The effort is part of MD Anderson's Moon Shots Program® , a collaborative effort to accelerate the development of scientific discoveries into clinical advances that save patients' lives. (mdanderson.org)
  • New Drug Development: Clinical Trials Design in CRPC -- 12. (nshealth.ca)
  • This involved the development of several new clinical processes to maintain high quality samples and flexible pathways for the use of PBMCs," commented Haiko Pillu, Director Operations, CPU, SGS. (appliedclinicaltrialsonline.com)
  • Delivering solutions in Europe and in the Americas, SGS offers clinical trial (phase I to IV) services encompassing drug development consultancy, clinical project management and monitoring, biometrics, PK/PD modeling and simulation, and regulatory and medical affairs services. (appliedclinicaltrialsonline.com)
  • The initiation of SGI-110's Phase 2 expansion of the clinical trial marks an important milestone for our company as we advance the development of our second-generation hypomethylating agent," said James S.J. Manuso, PhD, chairman & chief executive officer. (technologynetworks.com)
  • Conclusions: Based on Phase 1 OLE results showing no change from baseline in dystrophin expression, development of suvodirsen has been discontinued. (mdaconference.org)
  • Phase I clinical trial is the first exposure of investigational medicinal product in humans and it sets the pillar for further clinical development. (typeset.io)
  • Working as a nuclear medicine technologist on a clinical trial or with investigational radiopharmaceuticals can be quite different from working in an approved-drug setting in the clinic. (snmjournals.org)
  • Behavioral trials evaluate or compare ways to promote behavioral changes designed to improve health. (nih.gov)
  • One of the trials focuses on virus persistence and will evaluate longer-duration use of Paxlovid (nirmatrelvir and ritonavir) than is currently used for acute COVID infection. (umn.edu)
  • In the ever-changing field of clinical trial design, there is often a need to evaluate design options quickly and efficiently. (cytel.com)
  • Drug-docking techniques are also welcomed including confirmation and validation that molecular docking offers new viable drug therapy options, which could be used in clinical practice in the near future. (frontiersin.org)
  • Clinical practice guidelines for treatment of drug-susceptible TB in the United States were published in 2016 ( 2 ). (cdc.gov)
  • News about a drug that has been called a "game changer" for the medical management of obesity resulted in this week's top trending clinical topic. (medscape.com)
  • Although SURPASS-2 may not have favored semaglutide, interest in its potential role in aiding patients with weight loss helped the drug become this week's top trending clinical topic. (medscape.com)
  • Background/aims The Food and Drug Administration Amendments Act mandates that applicable clinical trials report basic summary results to the ClinicalTrials.gov database within 1 year of trial completion or termination. (nih.gov)
  • Methods We identified pulmonary clinical trials subject to the Food and Drug Administration Amendments Act (called highly likely applicable clinical trials) that were completed or terminated between 2008 and 2012 and reported results by September 2013. (nih.gov)
  • In First Phase 3 Trial, the Tau Drug LMTM Did Not Work. (alzforum.org)
  • This report provides a recommendation for using a 4-month regimen consisting of 8 weeks of daily treatment with rifapentine (RPT), isoniazid (INH), pyrazinamide, and moxifloxacin (MOX), followed by 9-weeks of daily treatment with RPT, INH, and MOX in patients with drug-susceptible tuberculosis. (cdc.gov)
  • The 4-month RPT-MOX regimen is a treatment option for patients aged ≥12 years with drug-susceptible pulmonary tuberculosis. (cdc.gov)
  • The trial confirmed that a 4-month daily treatment regimen containing high-dose RPT and MOX, as well as INH and PZA, is as effective as (noninferior to) the standard daily 6-month regimen in curing drug-susceptible TB ( 1 ). (cdc.gov)
  • CDC recommends the 4-month RPT-MOX regimen for treating patients aged ≥12 years with body weight ≥40 kg with pulmonary TB caused by organisms that are not known or suspected to be drug-resistant and who have no contraindications to this regimen. (cdc.gov)
  • In addition, granting access to an investigational drug through an expanded access program should not delay, interfere or compromise the completion of clinical trials that are intended to support the drug's approval, according to PhRMA. (outsourcing-pharma.com)
  • The drug achieved excellent hypomethylation, and major clinical responses in heavily pre-treated AML patients were observed. (technologynetworks.com)
  • A new drug to treat ovarian cancer is set to enter the phase 3 UP-NEXT trial imminently. (pharmafocus.com)
  • Patients will be treated with either intravenous upifitamin rilsodotin or a placebo drug every four weeks following a round of chemotherapy treatment. (pharmafocus.com)
  • Dr Amanda Jackson, physician-researcher at the University of Cincinnati and principal investigator for the UP-NEXT trial, commented: "The drug is considered a maintenance medication. (pharmafocus.com)
  • Which phase of clinical trial conducted after a drug is marketed? (typeset.io)
  • However, the new guideline suggests an investigational new drug filing system, in which, the clinical trial may be initiated 60 working days after filing the application if no negative or questioned review opinions are received. (typeset.io)
  • Clinical trials and drug approvals continue to accelerate in China. (typeset.io)
  • How many phase of the clinical trials are required to approve a new drug? (typeset.io)
  • Which clinical trial phase comes after the drug is approved for market? (typeset.io)
  • Thus, rigorous evidence obtained from large, high-quality randomized controlled trials must be presented to the concerned regulatory authorities of individual countries or regions. (mdpi.com)
  • Pfizer , however, an American company partnering with German-based BioNTech, is looking to conduct global phase 3 trials, although the partners have not yet announced the sites where these trials would take place. (go.com)
  • For guidance on NIAID clinical trial monitoring requirements, see NIAID Clinical Terms of Award and follow all application instructions. (nih.gov)
  • Citation bias favoring positive clinical trials of thrombolytics for acute ischemic stroke: a cross-sectional analysis. (jameslindlibrary.org)
  • Acute phase of SCI - begins immediately after the injury and can last days. (nascic.org)
  • Astex Pharmaceuticals, Inc. has announced that it has initiated the Phase 2 dose expansion segment of the clinical trial of SGI-110, a novel hypomethylating agent, in patients with intermediate-2 or high-risk myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML). (technologynetworks.com)
  • Clinical trial sites in Ukraine and Russia typically charge lower fees than the U.S. (healthydebate.ca)
  • Biostatisticians typically power trials to limit the chance of getting a false positive result to 5 percent or less. (alzforum.org)
  • The FDA approval was based on results from the Semaglutide Treatment Effect in People With Obesity (STEP) program of four phase 3 clinical trials. (medscape.com)
  • Factors associated with reporting results for pulmonary clinical trials in ClinicalTrials.gov. (nih.gov)
  • We aimed to determine the proportion of pulmonary trials reporting basic summary results to ClinicalTrials.gov and assess factors associated with reporting. (nih.gov)
  • We estimated the cumulative percentage of applicable clinical trials reporting results by pulmonary disease category. (nih.gov)
  • Results Of 1450 pulmonary highly likely applicable clinical trials, 380 (26%) examined respiratory neoplasms, 238 (16%) asthma, 175 (12%) chronic obstructive pulmonary disease, and 657 (45%) other respiratory diseases. (nih.gov)
  • Results of the eagerly awaited Phase 3 clinical trial of LMTM, a derivative of the dye methylene blue , generated consternation at the Alzheimer's Association International Conference 2016, held July 22-28 in Toronto. (alzforum.org)
  • The results are disappointing," said David Knopman, Mayo Clinic, Rochester, Minnesota, who chaired the press briefing but was not involved in the trial. (alzforum.org)
  • Secondary results are interesting, but our experience in this field, and in trials in general, tells us that secondary analyses are fraught with hidden bias. (alzforum.org)
  • These results support advancing the 15 mg dose into Phase 2. (mdaconference.org)
  • He added, "One of the processes to optimize the handling of PBMCs in early phase trials is the use of the all-in-one Cell Preparation Tubes, which, compared to the traditional Ficoll method, require less training of site staff, are less labor intensive, give better results in terms of viability and yield, and allow more time for the processing steps when conducting a clinical trial. (appliedclinicaltrialsonline.com)
  • STEP 4 - an international, multicenter trial - found that weekly injections helped patients maintain, and even increase, their initial weight loss on the agent when they continued treatment beyond 20 weeks . (medscape.com)
  • The medical journey for many Ukrainian patients, with fewer treatment options compared to North America or Europe, leads more quickly to enrollment in clinical trials. (healthydebate.ca)
  • Filorexant was studied for but was not found to be effective in the treatment of diabetic neuropathy, migraine, and major depressive disorder in phase 2 clinical trials. (wikipedia.org)
  • Treatment was well-tolerated with an overall response rate of 50%, including early and sustained CR in four patients, three of whom had extracellular mutations of KIT , and PR in one case. (qxmd.com)
  • Stopping randomized trials early for benefit and estimation of treatment effects: systematic review and meta-regression analysis. (jameslindlibrary.org)
  • If a new treatment is successful in one phase it moves to the next phase. (moreinfo.info)
  • Phase 1 trials are designed to find a safe dose of the new treatment, determine how the treatment should be given, and learn how it affects the body. (moreinfo.info)
  • If a safe doses found the new treatment goes to phase 2 testing. (moreinfo.info)
  • If a new treatment is found to be safe and have some benefit, it goes to phase 3. (moreinfo.info)
  • Phase 3 trials compared the new treatment with the current treatment to see which one is better. (moreinfo.info)
  • Comments were addressed by developing content to be published at https://www.cdc.gov/tb/topic/treatment/tbdisease.htm . (cdc.gov)
  • The 4-month daily treatment regimen consists of an intensive phase composed of 8 weeks of daily treatment with RPT, MOX, INH, and PZA, followed by a continuation phase of 9 weeks of daily treatment with RPT, MOX, and INH ( Table 1 ). (cdc.gov)
  • Sandip Patel, MD, principal investigator for the FT500 trial at Moores Cancer Center and lead physician for Ruff's NK cell therapy treatment, is excited by the prospect of cell-based immunotherapy in solid tumors. (ucsd.edu)
  • Built on the proven InVision ® platform, the personalized RaDaR assay has been designed to detect MRD following curative intent or definitive treatment, and early signs of relapse, and has been validated for clinical use in breast, colorectal, head and neck, as well as lung cancers. (accesswire.com)
  • Innovative Clinical Trial Design: Commercial vs Open-Source Software? (cytel.com)
  • Cytel is delighted to have Kannan Natarajan speaking at the "Complex Innovative Trial Design Symposium and East User. (cytel.com)
  • Imatinib in systemic mastocytosis: a phase IV clinical trial in patients lacking exon 17 KIT mutations and review of the literature. (qxmd.com)
  • Status updates on clinical trial websites are often out-of-date and attempts to contact specific clinical trial site investigators across Ukraine have been unsuccessful. (healthydebate.ca)
  • Work in Kaufman's lab, in collaboration with Fate and investigators at the Masonic Cancer Center, University of Minnesota, defined conditions to efficiently produce NK cells at a scale suitable for clinical use. (ucsd.edu)
  • Improving personalized therapy approaches for upfront management of high-grade ovarian cancer is a focus of the Ovarian Cancer Moon Shot® , which is co-led by Westin and which provided support for the clinical trial. (mdanderson.org)
  • How many subjects are in a phase 1 clinical trial? (typeset.io)
  • Over 140 candidate vaccines have been developed globally, and 18 of them are currently in human trials. (go.com)
  • These bioinformatic techniques result in identifying candidates suitable for further analysis in tissue and animal models and human trials. (frontiersin.org)