Catalogue Search | MBRL
Are you sure you want to remove the book from the shelf?
{{itemTitle}}
14,214
result(s) for
"Williams, Rebecca"
Sort by:
Terminated Trials in the ClinicalTrials.gov Results Database: Evaluation of Availability of Primary Outcome Data and Reasons for Termination
Clinical trials that end prematurely (or \"terminate\") raise financial, ethical, and scientific concerns. The extent to which the results of such trials are disseminated and the reasons for termination have not been well characterized.
A cross-sectional, descriptive study of terminated clinical trials posted on the ClinicalTrials.gov results database as of February 2013 was conducted. The main outcomes were to characterize the availability of primary outcome data on ClinicalTrials.gov and in the published literature and to identify the reasons for trial termination. Approximately 12% of trials with results posted on the ClinicalTrials.gov results database (905/7,646) were terminated. Most trials were terminated for reasons other than accumulated data from the trial (68%; 619/905), with an insufficient rate of accrual being the lead reason for termination among these trials (57%; 350/619). Of the remaining trials, 21% (193/905) were terminated based on data from the trial (findings of efficacy or toxicity) and 10% (93/905) did not specify a reason. Overall, data for a primary outcome measure were available on ClinicalTrials.gov and in the published literature for 72% (648/905) and 22% (198/905) of trials, respectively. Primary outcome data were reported on the ClinicalTrials.gov results database and in the published literature more frequently (91% and 46%, respectively) when the decision to terminate was based on data from the trial.
Trials terminate for a variety of reasons, not all of which reflect failures in the process or an inability to achieve the intended goals. Primary outcome data were reported most often when termination was based on data from the trial. Further research is needed to identify best practices for disseminating the experience and data resulting from terminated trials in order to help ensure maximal societal benefit from the investments of trial participants and others involved with the study.
Journal Article
Looking to Livestock: Gauging the Evolution of the EU's Agri-Climate Law and Policy
Awareness of agricultural climate impacts is growing. In the European Union (EU), the agricultural sector is responsible for significant greenhouse gas emissions while continuing to receive considerable EU budgetary support. A large share of agricultural emissions is linked to livestock husbandry, a sector the direct and indirect climate impacts of which the EU's ‘green’ agricultural policies have historically ignored. This blind spot extends to the sizeable global deforestation footprint from EU livestock feed imports that remains unaddressed, despite the EU's aspired status as a global climate leader and major global agricultural market player. This article benchmarks the evolution of EU agri-climate legal and policy developments, using livestock emissions as a case study to highlight the importance of learning from the successes and failures of the EU experience, to realize future attempts to tackle global agricultural emissions.
Journal Article
Trial Reporting in ClinicalTrials.gov — The Final Rule
The final rule for reporting clinical trial results has now been issued by the Department of Health and Human Services. It aims to increase accountability in the clinical research enterprise, making key information available to researchers, funders, and the public.
Title VIII of the Food and Drug Administration (FDA) Amendments Act of 2007 (FDAAA) expanded the legal mandate for sponsors and others responsible for certain clinical trials of FDA-regulated drug, biologic, and device products to register their studies and report summary results information to ClinicalTrials.gov,
1
which is managed by the National Library of Medicine at the National Institutes of Health (NIH). The statute expanded registration requirements and provided a legally defined timeline with specific requirements for the systematic reporting of summary trial results. Although statutory components took effect before 2010, the FDAAA directed the Department of Health and Human Services . . .
Journal Article
10-Year Update on Study Results Submitted to ClinicalTrials.gov
A decade after ClinicalTrials.gov launched a database for reporting results of clinical trials, the database includes results of approximately 36,000 trials. The authors discuss laws, regulations, and policies relevant to results reporting, trends over time in the frequency of reporting, and adherence to requirements for the completeness and quality of the results reported.
Journal Article
Update on Trial Registration 11 Years after the ICMJE Policy Was Established
More than a decade ago, the International Committee of Medical Journal Editors established a policy requiring trial registration. This article reviews the current state of this endeavor.
Laws and policies to establish a global trial reporting system have greatly increased the transparency and accountability of the clinical research enterprise. The three components of the trial reporting system are trial registration, reporting of aggregate results, and sharing of individual participant data.
1
Trial registration is foundational to our understanding and interpretation of trial results, because it requires that information be provided about all relevant clinical trials (to put results in a broad context) and their prespecified protocol details (to ensure adherence to the scientific plan).
In this article, we describe the current trial registration landscape and summarize evidence of . . .
Journal Article