Guidance clinical trials as topic. Medical search. Frequent questions

These events culminate with the 2-day NIH Grants Conference, Feb 1-2, 2023, which includes over 25 different topics on funding, policies, and processes shared by NIH and HHS experts. (nih.gov)
On May 1, 2023, the U.S. Food and Drug Administration (FDA) released an updated Draft Guidance on decentralized trials. (appliedclinicaltrialsonline.com)
Lilly's 2023 guidance outlines plans to advance five new drugs into late-stage clinical study and shepherd four into regulatory review, while two already approved diabetes drugs, Mounjaro and Jardiance, could gain expanded uses. (biopharmadive.com)
We used PubMed, MEDLINE, EMBASE, Cochrane, and ScienceDirect databases to identify clinical studies conducted between January 1975 and April 2023. (bvsalud.org)

This guidance is intended to assist sponsors, institutions, institutional review boards (IRBs), and clinical investigators involved in multicenter clinical research in meeting the requirements of 21 CFR part 56 by facilitating the use of a centralized IRB review process (use of a single central IRB ), especially in situations where centralized review could improve efficiency of IRB review. (fda.gov)
These changes have placed considerable burdens on IRBs and on sponsors and clinical investigators who are seeking IRB review for multicenter trials. (fda.gov)
Given the evolving situation, with likely increasing impacts on investigators, staff and supply chains, sponsors should carefully consider the ability to effectively mitigate risks such that patient safety and trial integrity are assured," the FDA said. (centerwatch.com)
On March 18, 2020, FDA released a guidance for industry, investigators, and institutional review boards conducting clinical trials during the coronavirus (COVID-19) pandemic. (biopharminternational.com)
With this guidance issued today, FDA is helping industry and investigators navigate the COVID-19 pandemic and help assess how to move forward with critical clinical trials," said Anand Shah, MD, FDA deputy commissioner for Medical and Scientific Affairs, in the press release. (biopharminternational.com)
This course benefits professionals involved in all aspects of clinical research including sponsor clinical development personnel, quality assurance and compliance, investigators, monitors, regulatory affairs personnel, data managers, and safety surveillance personnel. (ucsc-extension.edu)
At the roundtable, we talked about the differences in the perspectives that researchers and regulators bring to natural products clinical trials, and the challenges investigators face in understanding and complying with the complex regulations that apply to studies in this field. (nih.gov)
The advocates collaborate with breast cancer investigators within and beyond DF/HCC in planning and reviewing translational and clinical research in all its stages, with the goal of finding better treatments, improving patient outcomes, and ultimately preventing breast cancer. (harvard.edu)
Members serve on review panels for various local and national grant mechanisms, participate in concept discussions for new projects, provide input to improve clinical trial concepts, protocols and consent documents, serve on the Clinical Trials Committee, and partner with investigators on funded research and in the development of research proposals. (harvard.edu)
Project leaders for all scientific areas of interest (Topics #1-3) are restricted to early career investigators who have never received an R01-equivalent, P-series or U-series research grants, and established investigators new to HIV. (ucsd.edu)

The FDA issued a guidance yesterday on how the COVID-19 Pandemic may affect the conduct of clinical trials. (cytel.com)
In a press release outlining the details of the guidance, FDA acknowledged the impact potential quarantines, site closures, travel limitations, and interruptions to the supply chain will have on the conduct of clinical trials of medical products, including drugs, devices, and biological products. (biopharminternational.com)
Guidance documents listed below represent the agency's current thinking on the conduct of clinical trials, good clinical practice and human subject protection. (pagefreezer.com)

The European Medicines Agency has published draft guidance on the protection of personal data and commercially confidential information in the Clinical Trial Information System (CTIS) for consultation, which will end on 8 September 2022. (lexology.com)
Join experts from the NIH Division of Human Subjects Research and HHS Office of Human Research Protections (OHRP) for answers to these questions and more at the Human Subjects Research: Policies, Clinical Trials, & Inclusion event on December 6 and 7, 2022. (nih.gov)
Since 31 January 2022, the Clinical Trials Regulation 536/2014 (CTR) is applicable. (gmp-navigator.com)
Key clinical information presented at the American College of Cardiology (ACC) 2022 Scientific Session led to increased interest in heart failure (HF), specifically new guidelines, resulting in this week's top trending clinical topic. (medscape.com)
In other headline-making news from the ACC 2022 Scientific Session, results of a study simultaneously published in The Lancet showed that a low-sodium diet was not associated with reduced future clinical events in ambulatory patients with HF. (medscape.com)

TORONTO , April 15, 2021 /PRNewswire-PRWeb/ -- Although a well-recognized diagnostic endpoint in clinical care and drug development, blood pressure assessment continues to be an important topic of discussion in drug development. (prweb.com)
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)
As for clinical implications, the 2021 version of the Surviving Sepsis Campaign (SSC) guidelines included a meta-analysis of 10 randomized, controlled trials that showed improved mortality associated with vasopressin use. (medscape.com)

The EU Clinical Trials Regulation (1) was introduced to increase the availability of information regarding clinical trials, including their results. (lexology.com)
While the EU Clinical Trials Regulation aims to increase transparency, it also sets out requirements in relation to personal data and commercially confidential information. (lexology.com)
As a consequence of implementation of the Clinical Trial Regulation 536/2014 four new public consultations concerning good manufacturing practices and clinical trials for human medicinal products were opened August 28, 2015. (gmp-compliance.org)
Because of delays in implementing the EU regulation, the UK's compliance with future EU clinical trials rules will likely be subject to negotiation, as the country plans to only immediately implement EU regulations that were in place ahead of the planned March 2019 exit from the EU, according to a UK government official. (fdanews.com)
The European Medicines Agency added a disclaimer to the Reflection paper on the use of interactive response technologies (interactive voice/web response systems) in clinical trials, with particular emphasis on the handling of expiry dates to address its applicability regarding the European Clinical Trials Regulation (CTR). (gmp-compliance.org)
The response to the consultation on reforming the UK clinical trials regulation has been published. (gmp-compliance.org)
NCCIH created this new resource in response to an August 2020 roundtable in which we brought together academic researchers, representatives from industry, and representatives from the Federal Government to discuss the regulation of natural products clinical research. (nih.gov)

Information about FDA's National Center for Toxicological Research (NCTR), pediatrics, clinical trials, foods and veterinary medicine research, and more. (fda.gov)
In the intervening years, there has been substantial growth in the amount of clinical research generally, the number of multicenter trials, and the size and complexity of late-stage clinical trials. (fda.gov)
They offer direction on clinical trials to OneR, the in-house research arm of OneOncology. (ajmc.com)
Instead, they recommend approaches that identify risks to patient safety by utilizing critical data elements gathered in clinical data systems as a method of determining which sites warrant additional attention from clinical research associates (CRAs). (tableau.com)
Knowing what to expect and how to prepare for and respond to such inspections is as critical as conducting sound clinical research. (ucsc-extension.edu)
The VA should invest in research and provide guidance on psychedelics. (rand.org)
The market for clinical trial management system software is expected to be worth nearly $1.8 billion by 2019 with much of the double-digit growth taking place in developing countries, according to Persistence Market Research. (fdanews.com)
Amid the push among House and Senate Republicans to pass a sweeping tax reform bill, clinical researchers called on the federal government to modernize the research and development tax credit. (fdanews.com)
The FDA will issue grants of $1 million each to Duke University and the Institute for Advanced Clinical Trials for Children to promote pediatric clinical trials and trial-related research. (fdanews.com)
Clinical trial sponsors are doing a better job of representing women in drug trials but still lag in representing racial minorities, according to FDA research. (fdanews.com)
An Alzheimer's research group offers positive news on clinical trials for Alzheimer's drugs as well as suggestions for the way forward, in a new report. (fdanews.com)
It can help you understand the U.S. Food and Drug Administration (FDA) regulatory requirements for research on natural products, including the need for an Investigational New Drug (IND) application for some clinical trials. (nih.gov)
We consider the new Natural Products Clinical Trials Resource to be a living toolbox and we will continue to refine and update to meet the needs of the research community. (nih.gov)
Because of the incentives inherent in the clinical research enterprise, randomized control trials (RCTs) are designed for the specific purpose of regulatory approval and maximizing market penetration. (nih.gov)
This paper investigates the convergence of incentives and circumstances that lead to widespread uncertainty in oncology and proposes new paradigms for clinical research, including pragmatic clinical trials, methodological guidance, and coverage with evidence development. (nih.gov)
Each of these initiatives would support the design of clinical research that is more informative for postregulatory decision makers, and would therefore reduce uncertainty and provide greater confidence in conclusions about the value of these treatments. (nih.gov)
Scientists and researchers frequently invite feedback and guidance from advocates on the direction of their research and its value to patients. (harvard.edu)
In addition, the advocates focus on topics directly affecting the patient experience, such as tissue banking, consenting for clinical trials, suggesting outcome measures that are important to patients, identifying gaps in research, and patient education. (harvard.edu)
The BCAG, which generally includes about 20 members, has substantial experience in partnering with clinical and translational researchers to generate ideas for new directions in research, and has co-developed and jointly led projects. (harvard.edu)
This release shows that the landscape of clinical research is rapidly evolving. (appliedclinicaltrialsonline.com)
The shift towards decentralized clinical trials presents an exciting opportunity for sponsors to improve patient engagement, enhance data quality, and accelerate clinical research. (appliedclinicaltrialsonline.com)
In this position paper we aimed to provide guidance from the global clinical research network (Pediatric Inflammatory Bowel Disease Network, PIBDnet) for designing clinical trials in PIBD in order to facilitate drug approval for children. (bmj.com)
The ICH E8 (R1) revision is intended to identify and modernize the current conduct of clinical research: Clinical trial design, planning, management, and conduct. (barnettinternational.com)
Experience results today with practical guidance, legal research, and data-driven insights-all in one place. (lexisnexis.com)
WREN welcomes inquiries from researchers interested in collaborating on primary care research topics. (wisc.edu)
We've advanced science by bringing together thousands of experts to analyse the ever-evolving evidence and distil it into guidance, and identify a research road map to fill the gaps in our knowledge. (who.int)
Human-based clinical research? (ohio.edu)
What research topic interests you? (ohio.edu)
Research foci includes disease mechanisms (inflammation and metabolic dysfunction in obesity and diabetes), interprofessional healthcare teams (education, technology, and healthcare delivery systems to train and support the healthcare team), and Patient and Population Health (clinical and behavioral outcomes for the prevention and treatment of obesity and diabetes in underserved populations). (ohio.edu)
Although this is not a recommendation by the SSC for a specific threshold of catecholamine dose where vasopressin should be initiated, this statement represents clinician interest and the need for further research on the topic," they note. (medscape.com)
One evidence-based (EB) research nursing course reference�Clinical Research Nurse Domain of Practice or Oncology Clinical Trials Nurse Competencies. (nursingacademicwriters.com)
IDSA convened a panel of six actively practicing infectious diseases specialists with clinical and research expertise in the treatment of antimicrobial resistant bacterial infections. (idsociety.org)
Phase 1 clinical trials are an integral component of the advancement in cancer research. (cancertherapyadvisor.com)
Research derived from phase 1 clinical trials can be vital to the development of new treatments. (cancertherapyadvisor.com)
Speakers highlighted the need for tools and innovations that enable rapid research and development (R&D) and manufacturing responses, including the optimization of clinical trials. (cdc.gov)
They also underscored the need for master protocols, enabling faster data sharing and balanced research participation between high-income countries and low-income and lower-to-middle-income countries, and innovations in clinical trial design and execution to compress timelines for delivering trial outcomes. (cdc.gov)
The second part provides detailed guidance on the objectives of research, the contents of a research protocol, and the methods of investigation for non-clinical studies and for Phase I to Phase IV clinical trials. (who.int)
In addition, the registry provides a means to share information about research findings and clinical trials. (cdc.gov)

This guidance applies to clinical investigations conducted under 21 CFR part 312 (investigational new drug application, or IND regulations). (fda.gov)
Find out more about the draft guidances on investigational new drug applications (INDs). (gmp-compliance.org)
The considerations include sponsors evaluating alternative methods for assessments and offering further safety monitoring for trial participants who no longer have access to investigational products or the investigational sites. (biopharminternational.com)

The agency noted that the risks and benefits of keeping a trial going are likely different than those involved in initiating trials other than ones evaluating COVID-19 treatments and vaccines. (centerwatch.com)
Results When asked what was important in deciding whether to join a trial, children, young people and parents prioritised information about what participation would involve, what the trial was testing, potential benefits and risks of participation and knowing they could leave the trial if they later changed their minds. (bmj.com)
The FDA advises that companies engaged in trials, specifically, the biopharmaceutical and medical device industries and their development organizations, should focus on what matters: risks to patients and risks to study data," Epstein says. (tableau.com)
The guidance details considerations FDA has set in place to assure the safety of participants while maintaining compliance with good clinical practices and minimizing risks to trial integrity. (biopharminternational.com)
We want to support the continuance of these clinical trials in compliance with good clinical practice and minimizing risks to trial integrity, while also safeguarding the health and well-being of study participants. (biopharminternational.com)
The use of risk-based monitoring in clinical trials is expected to climb - with many sponsors planning to implement policies for the first time over the next two years - driven by the need to reduce oversight costs and mitigate risks. (fdanews.com)
With our software solution, the N-SIDE Suite, and expert services, we streamline the clinical supply of pharmaceutical and biotech companies by accelerating clinical plans, mitigating risks and curbing drug waste. (arena-international.com)
Within this article, Amit Mahipal, MD, and Danny Nguyen, MD, explore both the risks and the potential for benefit for patients with cancer who participate in clinical trials. (cancertherapyadvisor.com)
While there are certainly risks for patients enrolled in a phase 1 trial, the benefit of treatment response in the era of rational, targeted therapy is increased when compared with the era of cytotoxic therapy. (cancertherapyadvisor.com)
We explore the benefits and risks that patients experience when participating in phase 1 clinical trials. (cancertherapyadvisor.com)

Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. (fda.gov)

This presentation will focus on the implementation of BP monitoring in clinical trials with specific attention to the considerations to monitoring blood pressure as a safety "Off-target" endpoint. (prweb.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)
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)
This document will assist Clinical Trial Networks (CTNs) and individual trialists to identify whether clinical implementation of an intervention is appropriate based on the results of a particular trial. (clinicaltrialsalliance.org.au)
The document outlines practical considerations for trialists in evaluating whether the results of their trial warrant direct implementation into policy or practice. (clinicaltrialsalliance.org.au)
As well as providing practical suggestions and signposting of approaches to dissemination and implementation of trial results. (clinicaltrialsalliance.org.au)
RE-AIM prioritization scores will inform dissemination and translation efforts, help clinical staff select feasible interventions for implementation, and support sustainability for those interventions. (cdc.gov)

The presentation will highlight the identification of design and analysis considerations for a study to define the potential BP signal, and also provide case study experience in implementing BP monitoring in clinical trials across different trial phases. (prweb.com)
Register for this session to hear a review of trial design considerations and technology/BP methodology selection using a case study approach. (prweb.com)
To complement the ACIP recommendations, the CDC has also published on our website clinical considerations for the use of the Pfizer-BioNTech vaccine. (cdc.gov)
These clinical considerations will be updated to include information on both authorized mRNA products. (cdc.gov)
We anticipate that the clinical considerations will be nearly identical at this time for both products other than the two differences that I've just mentioned. (cdc.gov)
FDA] released this guidance to emphasize that at all times, patients' safety should continue to be at the forefront of considerations. (biopharminternational.com)

No difference was observed on clinical outcomes. (bmj.com)

Results The commentary includes 18 statements for guiding data extrapolation from adults, eligibility criteria to PIBD trials, use of placebo, dosing, endpoints and recommendations for feasible trials. (bmj.com)
On Thursday, the FDA issued a draft guidance for industry titled, Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products Guidance for Industry. (wcia.com)
This draft guidance provides a 15-year update to the FDA's previous recommendations on efficacy endpoints for such products. (wcia.com)

Clinical investigations that are subject to the requirements of IND regulations must be reviewed and approved by an IRB in accordance with the requirements of 21 CFR part 56. (fda.gov)
The FDA issued a new version of the draft guidance on electronic systems in clinical Investigations. (gmp-compliance.org)

How can we build an efficient statistical protocol for a clinical trial, if we do not know the therapies that will be. (cytel.com)
Introduction The optimal trial design for assessing novel therapies in paediatric IBD (PIBD) is a subject of intense ongoing global discussions and debate among the different stakeholders. (bmj.com)
Oncology researchers have seen an increase in responses in many diseases due to recent phase 1 clinical trials testing targeted therapies. (cancertherapyadvisor.com)
Recent phase 1 clinical trials testing targeted therapies have increased responses in many diseases in which other lines of therapy have failed. (cancertherapyadvisor.com)
Today's draft guidance demonstrates the FDA's ongoing commitment to providing industry with up-to-date recommendations on how to approach developing new drug therapies. (wcia.com)

The FDA is asking the medtech industry for input on how the agency can support development of devices for use in non-clinical care settings and by diverse patient populations. (medtechdive.com)
Looking at information such as whether or not one product causes more fever than the other or is more effective in certain groups than the other, you have to take into account the populations that were different for these two vaccine clinical trials as well as the way of the solicited adverse events and the adverse events that they solicited for. (cdc.gov)
Select items within the scale were applicable to health equity, covering topics such as reaching under-served focus populations and acceptability to that population. (cdc.gov)

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. (fda.gov)

Last week Cytel launched a COVID-19 Trial Tracker, an Open Access tool to track the global response to the coronavirus. (cytel.com)
Further regulatory guidance has been released concerning the implications of the Coronavirus disease (COVID-19) on. (cytel.com)
Weighing public health measures that may be in place by federal and state authorities for the coronavirus, and if they could impact the trial. (centerwatch.com)

Conclusions 3 year treatment with ASU-E reduces the percentage of JSW progressors, indicating a potential structure modifying effect in hip OA to be confirmed, and the clinical relevance requires further assessment. (bmj.com)
Conclusions Our study provides insights into the information that families value when deciding about healthcare trial participation. (bmj.com)

The FDA invited comments from stakeholders on a new draft guidance for clinical trial designs and drug development programs to support indications for uncomplicated urinary tract infection (uUTI) treatments. (fdanews.com)
It is this uncertainty in the knowledge of the clinical harms and benefits associated with oncology treatments that prevents postregulatory decision makers from making accurate assessments of the value of these treatments. (nih.gov)
The results from phase 1 clinical trials can allow new treatments to progress further in drug development or halt that process altogether. (cancertherapyadvisor.com)
At the forefront of phase 1 clinical trials is the safety of every patient participant, which is particularly true when testing new oncologic treatments in which patients may risk potentially toxic treatments in the hope of slowing the progression of or even curing their disease. (cancertherapyadvisor.com)

Clinical researchers can use mobile technologies to improve the trial process if they focus on patient-centric measures and engagement with regulators, according to the Clinical Trials Transformation Initiative (CTTI). (fdanews.com)
Researchers from academia and industry described their personal experiences preparing for clinical trials that either did or did not require an IND. (nih.gov)
In a review published in the journal Chest , the researchers summarize the three large, randomized trials to date examining the use of norepinephrine and vasopressin in patients with septic shock. (medscape.com)
Because of insufficient evidence, the guidance was worded as "in our practice, vasopressin is usually started when the dose of norepinephrine is in the range of 0.25-0.5 mcg/kg/min," the researchers write. (medscape.com)
While patient selection continues to be a challenge for researchers who are conducting trials, the issue has been eased by thee introduction of prognostic models that assist oncologists and health care professionals in determining patients that would be most likely to benefit from trial participation have. (cancertherapyadvisor.com)

Clinical practice guidelines for treatment of drug-susceptible TB in the United States were published in 2016 ( 2 ). (cdc.gov)

See the full-text " Clinical Practice Guidelines by the Infectious Diseases Society of America for the Treatment of Methicillin-Resistant Staphylococcus Aureus Infections in Adults and Children ," or pick up the Feb. 1 issue of Clinical Infectious Diseases. (cdc.gov)
The Infectious Diseases Society of America (IDSA) identified the development and dissemination of clinical practice guidelines and other guidance documents as a top initiative in its 2019 Strategic Plan [3]. (idsociety.org)
IDSA acknowledged that the ability to address rapidly evolving topics such as AMR was limited by prolonged timelines needed to generate new or updated clinical practice guidelines, which are based on systematic literature reviews and employ GRADE (Grading of Recommendations Assessment, Development, and Evaluation) methodology. (idsociety.org)
Additionally, when clinical trial data and other robust studies are limited or not available, the development of clinical practice guidelines is challenging. (idsociety.org)
As an alternative to practice guidelines, IDSA endorsed developing more narrowly focused guidance documents for the treatment of infections where data continue to rapidly evolve. (idsociety.org)

The CDC recommendation for initial linezolid dose within BPaL regimen changed from 1200 mg to 600 mg, based on results of the ZeNix trial. (cdc.gov)
Each disease group guides and approves OneOncology clinical pathways to reflect evidenced-based national guidelines, which are updated often as new trial results are published or presented at major scientific meetings. (ajmc.com)
These results can provide guidance in interpreting results and planning clinical trials. (nih.gov)
We have dynamic listing pages that pull in clinical trial results for specific disease types. (moz.com)
We're eagerly awaiting the results of two large, NIH-sponsored, randomized trials to further clarify the role of antibiotics in this setting. (cdc.gov)
Results from clinical trials help to answer questions and provide guidance for practicing health care pro-fessionals. (cancertherapyadvisor.com)
The results of the SODIUM-HF trial did show a moderate benefit on quality of life and New York Heart Association (NYHA) functional class. (medscape.com)

We empower clinical leaders to make better, faster and safer decisions for patients waiting for life-changing medications. (arena-international.com)
Forty patients with a diagnosis of rheumatoid arthritis participated in an evening of clinical assessment and one-on-one conversations with each other regarding their arthritic condition. (nih.gov)
In the Vasopressin in Septic Shock Trial (VASST), 382 patients with septic shock were randomized to open-label norepinephrine with blinded norepinephrine, and 382 were randomized to open-label norepinephrine with blinded adjunctive vasopressin. (medscape.com)
In the Vasopressin vs Norepinephrine as Initial Therapy in Septic Shock (VANISH) trial, 204 patients with septic shock were randomized to norepinephrine and 204 to vasopressin as an initial vasoactive agent. (medscape.com)
The third clinical trial, published only as an abstract, randomized 387 patients with septic shock who were already receiving low doses of norepinephrine to either norepinephrine with adjunctive vasopressin or norepinephrine alone. (medscape.com)
While patient safety is always a chief concern within a clinical trial, some patients fear the risk of participating in experimental treatment. (cancertherapyadvisor.com)
They show how rules and regulations have been created to protect patients and their interests while participating in trials. (cancertherapyadvisor.com)
In the modern era of oncology treatment, phase 1 clinical trials are sometimes the most valuable therapeutic option for patients who progress despite standard of care therapy for their disease. (cancertherapyadvisor.com)
Rules and regulations have been put into place to protect the safety and interests of patients while undergoing clinical trials. (cancertherapyadvisor.com)
Selecting patients with cancer who will survive long enough to accrue data for these trials continues to be challenging. (cancertherapyadvisor.com)
New prognostic models have been validated to help health care profession-als select those patients who will likely benefit from participation in phase 1 trials. (cancertherapyadvisor.com)
There also are long-lasting positive and negative impacts on those patients who choose to participate in phase 1 clinical trials. (cancertherapyadvisor.com)
Modern phase 1 clinical trials represent a therapeutic option for many patients who progress through frontline therapy for their malignancies. (cancertherapyadvisor.com)
From new insights into potential interventions to updated guidance designed to better help clinicians care for patients with or at risk for HF, a wealth of clinical information on a key cardiac condition led to this week's top trending clinical topic. (medscape.com)
RÉSUMÉ La présente étude a examiné les connaissances et la compréhension actuelles des patients en matière de substitution par des génériques. (who.int)
À notre avis, la substitution par des génériques ne doit pas être mise en oeuvre de manière aléatoire en raison de l'incertitude et des faibles connaissances des patients. (who.int)

Efforts were made to balance the ideal with the feasible, promoting a focused and coordinated source of guidance for health care providers. (cdc.gov)

Read the new edition of the Practical Guidance Journal for insights into how Generative AI is transforming the legal world. (lexisnexis.com)
Visit the Legal Developments page for the latest topics, including breaking legal news and related Practical Guidance content. (lexisnexis.com)
Check out our Practical Guidance Author Center ! (lexisnexis.com)
Learn about the 1750+ leading attorney authors contributing to our 26 practice areas, and find out how you can Become a Practical Guidance Author . (lexisnexis.com)
Practical Guidance is committed to amplifying diverse voices of attorneys across all differences, including gender and race. (lexisnexis.com)
For practical guidance on working with WREN , please read this recent WREN publication. (wisc.edu)
The chapter primarily addresses the range of services OEHS professionals provide and gives practical guidance on both becoming and selecting a consultant. (cdc.gov)

One of the primary goals of this session is to provide insight and clarification associated with the draft guidance. (prweb.com)
By integrating your clinical packaging seamlessly, we provide unified project management and total visibility. (arena-international.com)
The goal of the updated ICH E8 (R1) guidance is to provide flexibility in addressing the increasing diversity of study types and data sources that are being employed to support regulatory and other health policy decisions. (barnettinternational.com)
This web seminar will describe the ICH E8 (R1) addendum in a step-by-step process and provide a parallel discussion of how the reviewed guideline can improve efficient approaches to trial management. (barnettinternational.com)
Legal Developments provide the latest updates and analyses of emerging topics impacting your practice area. (lexisnexis.com)
Although brief descriptions of notable clinical trials, resistance mechanisms, and antimicrobial susceptibility testing (AST) methods are included, the document does not provide a comprehensive review of these topics. (idsociety.org)
Summit participants also noted that regulators must come to a consensus regarding requirements for clinical trial data, become more familiar with technology platforms through review of data across various pathogens over time, and provide guidance on the feasibility of alternative pathways to emergency use approval, especially in the context of the 100 Days Mission ( 10 ). (cdc.gov)

The guidelines address 11 topics commonly encountered by adult and pediatric clinicians. (cdc.gov)

The guidance provides a set of principles for using a systems approach to minimize medication errors relating to drug product design and container closure design to enhance patient safety. (gmp-compliance.org)
Patient safety is the most important factor to consider when deciding whether to suspend or continue a trial already in progress or to initiate a study during the national health emergency, the FDA said. (centerwatch.com)
This should be done using a standard approach that identifies the people on the call, reviews the informed consent with the patient by the investigator, answers any patient questions and confirms various issues, such as the patient's willingness to participate in the trial. (centerwatch.com)
Forster said that the guidance supports increased IRB flexibility during this time - allowing sponsors to bundle amendments and institute changes to deal with apparent immediate hazards or threats to patient safety - but doesn't explain how sponsors should streamline IRB reporting. (centerwatch.com)
The development of the draft FDA pressor effect guidance evolved out of industry and regulatory discussions with the goal of enhancing patient safety. (prweb.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)
To determine the point at which differences in clinical assessment scores on physical ability, pain and overall condition are sufficiently large to correspond to a subjective perception of a meaningful difference from the perspective of the patient. (nih.gov)
This is particularly true in the area of oncology, for which published evidence from clinical trials is often incongruent with real-world patient care, and a substantial portion of clinical use is for off-label indications that have not been systematically evaluated. (nih.gov)
As with all IDSA guidelines, they are voluntary and are not meant to replace clinical judgment, but rather synthesize the available evidence and support the decision-making process, which must be individualized for each patient. (cdc.gov)
Future studies of vasopressin should focus on the timing of its initiation at various clinical thresholds and patient selection for receipt of vasopressin," they conclude. (medscape.com)

The draft guidance outlines the FDA's general recommendations around evaluating the efficacy of antidiabetic drugs for adults and children with type 1 and/or type 2 diabetes. (wcia.com)

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. (fda.gov)

Expected increases in sales and R&D spending will be accompanied by a lengthy clinical and regulatory agenda in diabetes, obesity and Alzheimer's disease. (biopharmadive.com)
Eli Lilly expects both sales and drug development costs to rise next year as part of an ambitious annual plan it laid out Tuesday that foresees clinical progress and regulatory action for new drugs in obesity, diabetes, Alzheimer's and autoimmune diseases. (biopharmadive.com)

The turning point in medication development that resulted in the rigorous, regimented development of clinical trials in the United States occurred in 1937 when pharmaceutical manufacturer S.E. Massengill Company (Bristol, Tennessee) released the first elixir formulation of sulfanilamide, an antibiotic that, at the time, had been shown to have activity against strep-tococcal throat infections. (cancertherapyadvisor.com)

Objectives To understand stakeholders' views regarding the content and design of paediatric clinical trial multimedia websites. (bmj.com)
It provides guidance on the design of information resources to appeal to children and young people, while also being acceptable to parents and professionals who are often gatekeepers of children's access to information. (bmj.com)

This past week saw publication of an update to the 2007 COURAGE trial which compared optimal medical therapy (OMT) to stenting (PCI) as the initial management strategy for stable coronary artery disease. (ptca.org)
The most current version of this IDSA guidance document and corresponding date of publication is available at: www.idsociety.org/practice-guideline/amr-guidance. (idsociety.org)

January 10, 2018 - NIBIB Notice of Clarification of Preliminary Data and Clinical Trials Support for PAR-18-207. (nih.gov)

He is a pediatrician from the University of Tennessee, College of Medicine, and later on he will be talking to us about medical monitoring and give a presentation about how we establish guidelines for clinical practice. (cdc.gov)
Topics covered range from the information required to establish the identity and quality of plant materials or preparations, through the selection of appropriate test systems for pharmacodynamic studies, to detailed advice on the many different tests, examinations, observations, and experimental procedures required, in experimental animals and controls, to establish the safety of herbal medicines. (who.int)

Included in the webinar will be a review of the BP monitoring options that have been implemented in clinical trials including: Ambulatory Blood Pressure Monitoring (ABPM), Automated Office Blood Pressure Monitoring (AOBPM) and remote telemonitored home blood pressure (BP). (prweb.com)
CLINTEL (formerly Advanced Bio-Logic Solutions) identified a growing need in drug development: enabling clinical development organizations to comply with FDA draft guidance on risk-based monitoring principles. (tableau.com)
The industry estimates that up to 30 percent of clinical trial costs are related to site monitoring. (tableau.com)
In August 2013, the FDA finalized guidance on the topic of a "risk-based approach" to monitoring clinical trials. (tableau.com)
The U.S. Food and Drug Administration (FDA) published the final Q&A paper on a risk-based approach to monitoring of clinical trials. (gmp-compliance.org)
The use of data collected by continuous glucose monitoring (CGM) systems, which allow for nonstop, passive glucose monitoring, in clinical trials to potentially support hypoglycemia labeling claims. (wcia.com)

Young people and parents trusted trial teams to follow regulatory and quality requirements and therefore did not think such information was a priority for the websites, although logos of trusted organisations could lend credibility. (bmj.com)
Information about helpful FDA regulatory documents and resources, including instructions for submitting an IND application, guidance on obtaining exemptions from IND requirements, and resources on botanical drug development. (nih.gov)
Guidance should be viewed as recommendations unless specific regulatory or statutory requirements are cited. (pagefreezer.com)

Yourway is The Biopharma Services Company changing the landscape of clinical supply chain solutions with a unique, single source model. (arena-international.com)

The draft guidance provides recommendations to pharmaceutical companies interested in participating in a program involving the submission of CMC information containing emerging manufacturing (including testing, packaging and labeling, and quality control) technology to FDA. (gmp-compliance.org)

Enter search terms to find related medical topics, multimedia and more. (msdmanuals.com)

she added, referring to the FDA slow-walking production documents from Pfizer's trial and using the brand name for Pfizer's vaccine. (nvic.org)
Guidance documents are not binding for FDA or the public. (pagefreezer.com)
Some links embedded within guidance documents may have changed since the document was published. (pagefreezer.com)
He has served as the lead author of numerous WHO guidance documents on topics such as ethical issues in infectious disease outbreaks, tuberculosis care and control, and clinical trials oversight. (shu.edu)
More than 600 draft guidance documents have been produced, with up to 9 million downloads per month. (who.int)
Guidance documents are prepared by a small team of experts, who answer questions about treatment based on a comprehensive (but not necessarily systematic) review of the literature, clinical experience, and expert opinion. (idsociety.org)

Discuss how regulations and guidance are applied to improve inspection readiness. (ucsc-extension.edu)

Following a good clinical practice (GCP) inspection at the Alkem Laboratories Ltd site in Taloja, India, which raised concerns regarding study data used to support EU marketing authorisation applications, the European Medicines Agency (EMA) has started a review of medicines for which studies have been conducted at this site. (gmp-compliance.org)
COURAGE: Does 15-Year Data Have Any Clinical Relevance? (ptca.org)
Since clinical trials are designed to collect important data about a potential drug's safety and efficacy, there's no shortage of data that can also be used to assess risk. (tableau.com)
The CLINTEL team, with its decade of experience offering electronic data collection system services for companies engaged in the clinical trials process, knew that an effort to enable this sort of analysis to clinically-focused users would face some distinct challenges. (tableau.com)
There are tools out there that are good at providing bio-statisticians flexible insight into clinical data, but study management teams are often left to access data from several different systems and make sense of it on their own. (tableau.com)
Through the Solidarity Trial, we've run one of the largest and most diverse clinical trials, to generate robust data on therapeutics. (who.int)
Recent advancements in CGM technology have led the agency to recognize the advantages of data collected from these systems in clinical drug development. (wcia.com)

A CDC writing group reviewed the evidence and drafted guidance for comments from external TB subject matter experts and for presentation for public comment. (cdc.gov)

If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. (fda.gov)

We are an active player in clinical trial supply chain management for over 20 years and have the majority of the top 20 pharmaceutical companies as clients. (arena-international.com)
We have the resources, experience and commitment to make your packaging and shipments faster, and management of trials easier and more efficient. (arena-international.com)
4G Clinical is a leader in randomization and trial supply management (RTSM) for the global life sciences industry, offering the only fully cloud-based, 100% configurable and flexible solution utilizing natural language processing (NLP) and integrated supply forecasting. (arena-international.com)
We offer a broad range of clinical trial services supply chain management, clinical trial procurement and logistics. (arena-international.com)
During this Live Online Training Course, well-experienced specialists will share their expert knowledge about important aspects of IMP Supplies and the Management of Clinical Trials. (gmp-navigator.com)
This Live Online Training Course has been designed by the ECA to enhance and broaden your knowledge and to consolidate the various aspects which need to be considered for an efficient management of clinical Trials. (gmp-navigator.com)
Specialists, managers and executives from R&D dealing with the various aspects of IMP supply and clinical trial management. (gmp-navigator.com)

As use of clinical pathways becomes more common in cancer care, a leading national platform for independent community practices is building the infrastructure to develop and maintain them. (ajmc.com)

The growing clinical impact of MRSA, particularly community-acquired infections, prompted the Infectious Diseases Society of America to develop its first treatment guidelines for MRSA. (cdc.gov)
Catherine Liu, MD, lead author of the IDSA MRSA guidelines and Assistant Clinical Professor in the Division of Infectious Diseases at University of California, San Francisco. (cdc.gov)

AWT Healthcare manufacturers clinical trial labels. (arena-international.com)
AWT Healthcare is solely focused on providing the clinical pharmaceutical and custom labels & packaging industry with state-of-the-art solutions at a fair price and competitive timing. (arena-international.com)

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)

Methods A writing group has been established by PIBDnet and topics were assigned to different members. (bmj.com)

The FDA now considering a reduction in the risk of hypoglycemia (low blood sugar) to be a clinically relevant outcome measure for diabetes drug clinical trials, when accompanied by either a reduction or maintenance of an acceptable A1C. (wcia.com)

The FDA has updated its guidance on conducting clinical trials during the COVID-19 pandemic with an extensive Q&A section, including a long list of factors to consider when deciding the status of ongoing trials and ones soon to be initiated, as well as how to obtain informed consent remotely. (centerwatch.com)

Pathways can then be utilized through clinical decision support tools and software. (ajmc.com)
Open to clinical trials networks, clinical trial coordinating centres and clinical quality registries that support ACTA's mission and vision and meet the membership criteria outlined. (clinicaltrialsalliance.org.au)

4G Clinical is headquartered in the Boston Biotech corridor of Wellesley, MA, with offices in Europe and Asia. (arena-international.com)

Please take a little time to look over the website and see whether it provides helpful guidance to inform your submission of an NIH application for a clinical trial. (nih.gov)

Anatomy6

Diseases18

Chemicals and Drugs22

Analytical, Diagnostic and Therapeutic Techniques and Equipment100

Psychiatry and Psychology17

Phenomena and Processes13

Disciplines and Occupations16

Anthropology, Education, Sociology and Social Phenomena19

Technology, Industry, Agriculture3

Humanities6

Information Science26

Named Groups4

Health Care97

Geographicals9

20234

Investigators10

Conduct of clinical trials3

20225

20213

Regulation7

Research38

Investigational3

Risks10

Agency's1

Implementation7

Considerations6

Outcomes1

Endpoints3

Investigations2

Therapies5

Populations3

Responsibilities1

Coronavirus3

Conclusions2

Treatments4

Researchers5

20161

Practice guidelines5

Results7

Patients16

Feasible1

Practical guidance7

Provide7

Pediatric1

Patient10

Outlines1

FDA's1

Alzheimer's2

Development of clinical1

Design2

Publication2

20181

Establish2

Monitoring6

Regulatory3

Landscape of clinical1

Draft guidance provides1

Search1

Documents6

Regulations and guidance1

Data7

Evidence1

Identify1

Management7

Practices1

Guidelines2

Healthcare2

Participants1

Methods1

Outcome1

Pandemic1

Support2

Biotech1

Inform1