Empowered by Fox Trial Finder, patients play a critical role in tackling the chronic challenge of recruitment
Phrma: 9/25/13 Guest Perspective: Elizabeth Joyce, Marketing & Communications Officer, The Michael J. Fox Foundation for Parkinson’s Research Recruiting volunteers to participate in clinical trials is a well-known and enduring obstacle to research progress, and the effect is staggering: 85 percent of trials across all diseases face delays and 30 percent never even get off the ground […]
An estimate of the science-wise false discovery rate and application to the top medical literature
Biostat: September 25, 2013 The accuracy of published medical research is critical for scientists, physicians and patients who rely on these results. However, the fundamental belief in the medical literature was called into serious question by a paper suggesting that most published medical research is false. Here we adapt estimation methods from the genomics community to […]
Subjective endpoints in clinical trials: the case for blinded independent central review
Dove press: 9/25/13 Abstract: Primary efficacy and safety endpoints in clinical trials are often subjective assessments made by site personnel. For international confirmatory trials conducted over broad geographic regions and different clinical practice settings, variability in these subjective assessments can be substantial. Centralized endpoint assessment committees (EACs) offer a mechanism through which to reduce assessment bias and […]
Large Simple Trials and Knowledge Generation in a Learning Health System – Workshop Summary
IOM: September 24, 2013 Despite a robust clinical research enterprise, a gap exists between the evidence needed to support care decisions and the evidence available. Streamlined approaches to clinical research provide options for progress on these challenges. Large simple trials (LSTs), for example, generally have simple randomization, broad eligibility criteria, enough participants to distinguish small […]
Realistic Recruitment Expectations Require Disease and Geographic Considerations
Applied Clinical Trials Online: Sep 24, 2013 Companies that seek to set realistic recruitment expectations should consider using key enrollment benchmarks which combine both disease and geographic information. This permits a more accurate view of enrollment performance based on the differences across regions within a given disease. Read more
More Voices Enter Clinical Trials Data Sharing Debate in Europe
Phrma: 9/20/13 A new paper released this week highlights issues surrounding the discussions on clinical trial data sharing. The paper, Clinical Trials and Data Transparency: The Public Interest Case, highlights specific problems to the current draft European Medicines Agency (EMA). Among the problems highlighted were gaps in the protection of patient privacy, further bureaucratization of an already bureaucratic system and conflicting policies on regulatory […]
ACRO’s new video series about the importance of clinical research
Research America: September 11, 2013 Clinical research is key to saving lives, lowering health care costs and reducing waste and inefficiencies in our health care system. To highlight the latest insights from prominent health and research leaders, The Association of Clinical Research Organization has launched a new video series about the importance of clinical research. In the latest […]
