• Conflicts of Interest and Outcomes of Cardiovascular Trials. (duke.edu)
  • Objective To evaluate the impact of non-blinded outcome assessment on estimated treatment effects in randomised clinical trials with binary outcomes. (bmj.com)
  • Outcomes in most trials were subjective-for example, qualitative assessment of the patient's function. (bmj.com)
  • 1 One challenge to the validity of such trials is the tendency for assessments of outcomes to systematically deviate from the truth because of predispositions in observers, such as from hope or expectation. (bmj.com)
  • Amsterdam, the Netherlands and Washington, D.C. - Royal Philips (NYSE: PHG, AEX: PHIA) today announced that the results from two large clinical trials comparing patient outcomes using instant wave-free ratio (iFR) and fractional flow reserve (FFR) in the diagnosis and treatment of heart disease have been published in the New England Journal of Medicine. (philips.com)
  • Despite the critical relevance of smoking to cancer outcomes, most oncology clinical trials do not collect data on smoking history and status unless the malignancy is widely acknowledged as smoking related (e.g., lung or head and neck cancer). (aacrjournals.org)
  • Changes in smoking status during treatment or follow-up are monitored in very few trials and are infrequently reported in sample descriptions or included in analysis plans as a potential moderator of outcomes. (aacrjournals.org)
  • Based on mounting evidence that tobacco use affects cancer treatment outcomes and survival, we recommend that smoking history and status be systematically collected as core data in all oncology clinical trials: at diagnosis, at trial registration, and throughout treatment and follow-up to long-term survival or death. (aacrjournals.org)
  • We feel that the inclusion and analysis of such data in clinical trials will add important information to the interpretation of outcomes and the development of scientific knowledge in this area. (aacrjournals.org)
  • Also eligible are biomarker- and outcomes-validation studies that are immediately preparatory to trials in stroke prevention, treatment, or recovery. (sbir.gov)
  • Nonsevere acute otitis media: a clinical trial comparing outcomes of watchful waiting versus immediate antibiotic treatment. (greenmedinfo.com)
  • Objectives: The aim of this article is to provide recommendations on the structure, materials, and outcomes that should be adopted for communication training programs designed to improve clinical trial education for patients. (intechopen.com)
  • Discussions about clinical trial participation are quite challenging due to the uncertainty regarding the outcomes of clinical trials, and the complex nature of consent documents [ 12 ]. (intechopen.com)
  • Radiological imaging has an important role in evaluating CLL and validating therapeutic agent response assessment outcomes in clinical trials. (parexel.com)
  • If income is associated with health status, then improving representativeness of lower-income patients in trials would improve the generalizability of study outcomes. (breastcancer.org)
  • We will develop a PMO to skip exon 53 and perform a clinical trial in DMD boys using a world leading pan-European consortium. (europa.eu)
  • As the vast majority of drugs tested in small animal cancer models fail in human clinical trials, there is a need for large animal models to translate results obtained in small animal models to human clinical practice. (frontiersin.org)
  • Utilization of large animal models also allows for testing of the same devices and tools used in human clinical practice in species with similar size, anatomy, physiology, metabolism, immunology, and genetics compared to humans. (frontiersin.org)
  • IGPH aims to provide information and facilitate the application of genomics-based knowledge and technologies in clinical and public health practice. (who.int)
  • When the completeness or accuracy of the medical literature - particularly publications of clinical trials - is in doubt, so too are standards of care, clinical practice guidelines, and systematic reviews. (fda.gov)
  • The affirmative decision of the IRB that the clinical trial has been reviewed (i.e. protocol, informed consent(s), conflict of interests, etc.) and may be conducted at the institution site within the constraints set forth by the IRB, the institution, good clinical practice (GCP), and the applicable regulatory requirements. (lymphedemapeople.com)
  • He is a Director of the Scientific Archivists Group, Co-Lead for the SAG GCP Special Interest Group, and former Executive Committee Member of the Good Clinical Practice Records Managers Association, promoting latest developments, trends, industry best practices and standards in the life sciences sector. (smi-online.co.uk)
  • We provide a suggested set of items for inclusion in clinical trial data sets that also are useful in clinical practice. (aacrjournals.org)
  • This Research Topic will also address training needs with regards to comparative pathology and the development of imaging standards to support relevant interpretation of findings and expedite the launch of human clinical trials. (frontiersin.org)
  • NeutNet, a group of 13 participants from all over the world, proposes to co-ordinate activities aimed at standardising methods for the measurements of neutralising antibodies to HIV-1 for use in human clinical trials of candidate AIDS vaccines. (europa.eu)
  • Conflicts of interests have long been recognized as potential sources of influence in the conduct and reporting of clinical trials. (duke.edu)
  • CCTN was established in 1996 to support research on male and female contraception and to conduct clinical trials of new contraceptive drugs and devices. (nih.gov)
  • PURPOSE: To identify areas of concern regarding the conduct of phase I trials, the perceived expectations and motivations of the parents of children entered, the expectations of toxicity and benefit, and the ethical concerns of pediatric hematologists and oncologists in the United Kingdom and North America. (isharonline.org)
  • Once a clinical study is completed, the clinical study records are the primary - and often the only - evidence of clinical study activities, which are critical to permitting evaluation of the conduct of the study and the quality of the data produced. (smi-online.co.uk)
  • In this issue of Mind the Brain, I demonstrate a quick assessment of the conduct and reporting of a clinical trial. (plos.org)
  • Economic return of clinical trials performed under the pediatric exclusivity program. (duke.edu)
  • A major objective of this funding opportunity announcement (FOA) is to invite SBIR applications to foster collaboration between clinical and bioengineering research communities to develop and test safe, accurate, and effective devices for use in neonatal, perinatal, and pediatric care settings. (sbir.gov)
  • Although restrictions exist to protect trade secrets, a company's competitive position, confidential information or other proprietary material, those laws aren't a blank cheque to refuse disclosure of clinical trials or safety data, Prof. Herder said. (theglobeandmail.com)
  • With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. (marketwatch.com)
  • The network is designed to increase the efficiency of stroke clinical trials by facilitating patient recruitment and retention, supporting novel methodologies and streamlined approaches to accelerate the development of promising stroke therapies, and enabling comparison between approaches. (sbir.gov)
  • Availability of clinical trial data should lead to more efficient development of new therapies, bolster better-informed use of medicines, and facilitate verification of the regulatory authority's decisions by third parties. (clinicalaccelerator.com)
  • 1 We suggest a scoring system for pooling this evidence and detail how this may be combined with hypothetical scenarios to assist in the design of, and justification for, a small randomised controlled trial. (bmj.com)
  • Preliminary results from one of the earliest clinical trials of CRISPR-Cas9 provide evidence that the technique is safe and feasible to use for treating human diseases. (bioportfolio.com)
  • When implementing a trial, try if you can to leave a clear audit trail of who had access to what evidence at which point in the trial. (cytel.com)
  • Since 2009, Dr. Doshi has worked with a team that sifted through FDA approval packages and formerly confidential clinical study reports of the anti-influenza drugs oseltamivir and zanamivir. (fda.gov)
  • Dr. McCormack: "It is now time to explore systematically how computer simulations can be used to improve clinical trials of drugs, devices, and biotechnology products. (europa.eu)
  • It's got to be started somewhere, and [sighs] if, if the phase 1 trial does work on some, they might be able to adjust it to do a different, using the same drugs used in a different way. (healthtalk.org)
  • Some trials test new drugs before the FDA approves them. (webmd.com)
  • For all the science behind today's drugs, it's often a trial-and-error process to find the ones that work best for you . (technologyreview.com)
  • It raises the question, why and how would we ever know the impact of drugs on women if only men are used in trials? (angrybearblog.com)
  • The decision casts a shadow on other similar classes of drugs such as Tocilizumab by Swiss drug maker Roche pharma, that are under trial for treating Covid-19 in countries including India. (indiatimes.com)
  • Tocilizumab and Remdesivir, two drugs that are still undergoing trials as possible treatment for Covid-19, are in huge demand. (indiatimes.com)
  • While these end points may be reasonable surrogates for the clinical effectiveness of drugs, a key point in their use as trial end points is the definition of a relevant duration of antiviral response. (ovid.com)
  • Many members of the medical profession have criticized the department for years over the fact results of clinical trials, which are used to make decisions on whether drugs or other health products should be approved in Canada, are kept secret. (theglobeandmail.com)
  • For years, Health Canada has tossed around the idea of creating a registry of clinical trials and being more open with information pertaining to drugs and health products. (theglobeandmail.com)
  • But Prof. Herder argues in his analysis that there is no law that prevents Health Canada from releasing clinical trial results or other important data that could significantly enhance awareness of potential problems with certain drugs. (theglobeandmail.com)
  • The Alliance works with partner organizations and government agencies such as FDA and NIH to increase older adult participation in clinical trials, including for diseases such as Alzheimer's disease. (agingresearch.org)
  • The NIH StrokeNet comprises a National Clinical Coordinating Center (NCC), a National Data Management Center (NDMC) and 25 geographically distributed Regional Coordinating Centers (RCC) with over 350 affiliated stroke centers. (sbir.gov)
  • Complexities in sample handling, instrument setup and data analysis are barriers to the effective use of flow cytometry to monitor immunological parameters in clinical trials. (duke.edu)
  • Identifying Barriers and Practical Solutions to Conducting Site-Based Research in North America: Exploring Acute Heart Failure Trials As a Case Study. (duke.edu)
  • The following websites offer information and services to help you find a clinical trial that is right for you. (webmd.com)
  • Clinical tests showed that hardware and software could be adjusted to the specific characteristics of these subjects providing a proof of the feasibility of our unique approach. (europa.eu)
  • Specifically, all subjects who had been mobile before the trial seemed to improve their walking speed and/or balance during training. (europa.eu)
  • This initial trial will evaluate Inovio's Ebola immunotherapy (INO-4212) in five groups of healthy subjects receiving INO-4212 and its components (INO-4201 and INO-4202) alone or in combination with INO-9012, delivered into muscle or skin using Inovio's proprietary DNA delivery technology. (marketwatch.com)
  • If you don't say that your glucosamine product treats arthritis, but you say that a clinical trial showed it supports joint health, this is still considered a health claim and requires substantiation. (mastercontrol.com)
  • The network is managed through NICHD's Division of Intramural Population Health Research and includes 19 sites for clinical evaluation of new female contraceptives and two sites for male contraceptives. (nih.gov)
  • A complete diagnostic evaluation should include a newborn screening, a sweat chloride test, a genetic or carrier test, and a clinical evaluation at a CF Foundation-accredited care center. (cff.org)