JAMA
September 10, 2014, Vol 312, No. 10
http://jama.jamanetwork.com/issue.aspx

Editorial | September 10, 2014
Open Access to Clinical Trials Data
Harlan M. Krumholz, MD, SM1; Eric D. Peterson, MD, MPH2,3
[+] Author Affiliations
JAMA. 2014;312(10):1002-1003. doi:10.1001/jama.2014.9647.
Excerpt
Well-conducted randomized clinical trials (RCTs) are the gold standard for evaluating the safety and efficacy of medical therapeutics. Yet most often, a single group of individuals who conducted the trial are the only ones who have access to the raw data, conduct the analysis, and publish the study results. This limited access does not typically allow others to replicate the trial findings. Given the time and expense required to conduct an RCT, it is often unlikely that others will independently repeat a similar experiment. Thus, the scientific community and the public often accept the results produced and published by the original research team without an opportunity for reanalysis. Increasingly, however, opinions and empirical data are challenging the assumption that the analysis of a clinical trial is straightforward and that analysis by any other group would obtain the same results.1- 3…

Medical News & Perspectives | September 10, 2014
Largest-Ever Outbreak of Ebola Virus Disease Thrusts Experimental Therapies, Vaccines Into Spotlight
Tracy Hampton, PhD
JAMA. 2014;312(10):987-989. doi:10.1001/jama.2014.11170.
As efforts to successfully contain the largest outbreak of Ebola virus disease in history prove elusive, the mounting number of cases and deaths has brought research to develop much-needed treatments and protective vaccines into the spotlight. Although the approval process for drugs and vaccines is typically slow and deliberate, the latest outbreak, declared by the World Health Organization (WHO) on August 8 as an international health emergency, has galvanized regulatory officials to consider proposals for providing as-yet unproven treatments under special emergency New Drug Applications.