Developing a guideline for clinical trial protocol content: Delphi consensus survey

gene September 24, 2012 Recent evidence has highlighted deficiencies in clinical trial protocols, having implications for many groups. Existing guidelines for randomized clinical trial (RCT) protocol content vary substantially and most do not describe systematic methodology for their development. As one of three prespecified steps for the systematic development of a guideline for trial protocol content, […]

A theoretical framework for early human studies: uncertainty, intervention ensembles, and boundaries Jonathan Kimmelman, September 2012 Clinical development of novel therapeutics begins with a coordinated sequence of early phase clinical trials. Such early human studies confront a series of methodological and ethical challenges. In what follows, I propose a theoretical framework for early human studies aimed at informing the negotiation of these challenges. At the outset of clinical […]

A Randomized Study of How Physicians Interpret Research Funding Disclosures 9/20/12 The effects of clinical-trial funding on the interpretation of trial results are poorly understood. We examined how such support affects physicians’ reactions to trials with a high, medium, or low level of methodologic rigor. We presented 503 board-certified internists with abstracts that we designed describing clinical trials of three hypothetical drugs. The trials had […]

Ten Pharmaceutical Companies Unite to Accelerate Development of New Medicines New Non-Profit Organization to Speed Pharmaceutical R&D, 9/19/12 PHILADELPHIA, Sept. 19, 2012 /PRNewswire/ — Ten leading biopharmaceutical companies announced today that they have formed a non-profit organization to accelerate the development of new medicines. Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson, Pfizer, Genentech a member of the Roche Group, […]

Assessing an Intervention to Improve Clinical Trial Perceptions Among Predominately African-American Communities in South Carolina

Project MUSE: Volume 6, Issue 3, Fall 2012 African Americans (AA) are not well-represented in cancer clinical trials despite having significantly higher cancer mortality rates than their European-American (EA) counterparts. Objectives: The purpose of this study was to evaluate a program to improve perceptions of cancer clinical trials among AA. Methods: The program was conducted in a convenience […]

Identifying Research Needs for Improving Health Care

The American College of Physicians: September 18, 2012. Insights from systematic reviews can help new studies better meet the priorities and needs of patients and communities. However, systematic reviews unfortunately have not yet achieved this position to direct and guide new research studies. The Agency for Healthcare Research and Quality’s Evidence-based Practice Center Program uses […]

Influence of Reported Study Design Characteristics on Intervention Effect Estimates From Randomized, Controlled Trials

The American College of Physicians: September 18, 2012. Published evidence suggests that aspects of trial design lead to biased intervention effect estimates, but findings from different studies are inconsistent. This study combined data from 7 meta-epidemiologic studies and removed overlaps to derive a final data set of 234 unique meta-analyses containing 1973 trials. Outcome measures […]

Can We Depend on Investigators to Identify and Register Randomized Controlled Trials? 9/11/12 To reduce publication bias, systematic reviewers are advised to search conference abstracts to identify randomized controlled trials (RCTs) conducted in humans and not published in full. We assessed the information provided by authors to aid identification of RCTs for reviews. Methods We handsearched the Association for Research in Vision and Ophthalmology (ARVO) meeting abstracts […]

Estimating treatment effects from a randomized clinical trial in the presence of a secondary treatment 4/17/12 In randomized clinical trials involving survival time, a challenge that arises frequently, for example, in cancer studies (Manegold, Symanowski, Gatzemeier, Reck, von Pawel, Kortsik, Nackaerts, Lianes and Vogelzang, 2005. Second-line (post-study) chemotherapy received by patients treated in the phase III trial of pemetrexed plus cisplatin versus cisplatin alone in malignant pleural mesothelioma. Annals of […]

A valid formulation of the analysis of noninferiority trials under random effects meta-analysis 3/30/12 A noninferiority (NI) trial is sometimes employed to show efficacy of a new treatment when it is unethical to randomize current patients to placebo because of the established efficacy of a standard treatment. Under this framework, if the NI trial determines that the treatment advantage of the standard to the new drug (i.e. S−N) […]

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