Rethinking the Vulnerability of Minority Populations in Research
American Journal of Public Health: 10/17 The Belmont Report, produced in 1979 by a United States government commission, includes minority populations among its list of vulnerable research participants. In this article, we consider some previous attempts to understand the vulnerability of minorities in research, and then provide our own account. First we examine the question of […]
The State of Infectious Diseases Clinical Trials: A Systematic Review of ClinicalTrials.gov
PLOS ONE: 10/16/13 There is a paucity of clinical trials informing specific questions faced by infectious diseases (ID) specialists. The ClinicalTrials.gov registry offers an opportunity to evaluate the ID clinical trials portfolio. Methods We examined 40,970 interventional trials registered with ClinicalTrials.gov from 2007–2010, focusing on study conditions and interventions to identify ID-related trials. Relevance to ID […]
Randomized Trials Analyzed as Observational Studies
Ann Intern Med.: October 15, 2013 Randomized trials are not always free of confounding and selection bias. This commentary posits that randomized trials with long follow-up are similar to observational studies and that “intention-to-treat” analysis of such studies may be inadequate. The authors propose use of g-methods to adjust for postrandomization confounding and selection bias. Read […]
Completeness of Reporting of Patient-Relevant Clinical Trial Outcomes: Comparison of Unpublished Clinical Study Reports with Publicly Available Data
PLOSONE: 10/8/13 Access to unpublished clinical study reports (CSRs) is currently being discussed as a means to allow unbiased evaluation of clinical research. The Institute for Quality and Efficiency in Health Care (IQWiG) routinely requests CSRs from manufacturers for its drug assessments. Our objective was to determine the information gain from CSRs compared to publicly […]
Collectively, rare diseases affect one in ten Americans
WASHINGTON, D.C. (October 7, 2013) America’s biopharmaceutical research companies are developing 452 new medicines for rare diseases, including genetic disorders, neurological conditions, infectious diseases and autoimmune disorders, according to a new report released today by the Pharmaceutical Research and Manufacturers of America (PhRMA). Biopharmaceutical research is entering an exciting new era with a growing understanding of the […]
Application of methods for central statistical monitoring in clinical trials
Clin Trials: October 1, 2013 Background On-site source data verification is a common and expensive activity, with little evidence that it is worthwhile. Central statistical monitoring (CSM) is a cheaper alternative, where data checks are performed by the coordinating centre, avoiding the need to visit all sites. Several publications have suggested methods for CSM; however, few have […]
Integrating biomarker information within trials to evaluate treatment mechanisms and efficacy for personalised medicine
Clin Trials: September 2, 2013 Background The development of personalised (stratified) medicine is intrinsically dependent on an understanding of treatment-effect mechanisms (effects on therapeutic targets that mediate the effect of the treatment on clinical outcomes). There is a need for clinical trial data for the joint evaluation of treatment efficacy, the utility of predictive markers as indicators […]
