Clinical Trial Transparency — Antidote to Weaker Off-Label-Promotion Rules?
NEJM: July 3, 2014 This year promises to be an auspicious period for some long-running battles over the dissemination of biomedical research. Some companies seeking more freedom to promote their products have bristled at recent guidance documents from the Food and Drug Administration (FDA) regarding promotion of drugs and devices for off-label uses, claiming that […]
Public-Private Partnerships Can Serve as Important Levers of Innovation
Phrma.org: 07.02.14 Collaboration was a central theme of the recent BIO International Convention, which featured panel discussions on AMP-lifying Innovation: NIH, Patient Organizations & Leading Biopharma Firms Mobilize to Tackle Tough Diseases and Playing Nice in the Sandbox: Pre-Competitive Research Consortiums Offer Quicker, Less Expensive Path to Better Medicines. Accelerating Medicines Partnership Aims to Speed Validation of Disease Targets […]
The Intention-to-Treat Principle
JAMA Guide to Statistics and Methods | July 2, 2014 How to Assess the True Effect of Choosing a Medical Treatment The intention-to-treat (ITT) principle is a cornerstone in the interpretation of randomized clinical trials (RCTs) conducted with the goal of influencing the selection of medical therapy for well-defined groups of patients. The ITT principle defines both […]
Available, accessible, aware, appropriate, and acceptable: a strategy to improve participation of teenagers and young adults in cancer trials
The Lancet:7/1/14 Under-representation of teenagers and young adults in clinical trials for cancer is acknowledged internationally and might account for the lower survival gains noted for this group. Little research has focused on strategies to increase participation of teenagers and young adults in clinical trials. We applied a conceptual framework for barriers to recruitment of […]
A Case for Diversity
SAN ANTONIO MAGAZINE / JULY 2014 Cancer Therapyy & Research Center makes strides in diversifying clinical trials When modern treatments for childhood leukemia began in the late 1950s, the cure rate for kids was still close to zero. After multiple clinical trials, in which doctors tested and improved medications, the mortality rate has decreased. Now, more than […]
Would you want to know if you’re likely to get Alzheimer’s disease?
Washington Post: 6/19/14 Last month, I wrote about the problems that pharmaceutical companies and other researchers have recruiting sufficient numbers of volunteers for clinical trials of medications that may prove valuable against a wide variety of disorders. Here is one example of how that may affect people who might benefit from that research. — Lenny Bernstein. `A large […]
Ethics and Regulatory Complexities for Pragmatic Clinical Trials
JAMA: 6/18/14 Some patients do not receive the best care possible, either because research to support clinical decision making with high-quality evidence is lacking or because evidence-based practices are not routinely implemented.1 Pragmatic clinical trials (PCTs), which include patients in routine clinical practice settings and typically incorporate comparative effectiveness research (CER)—that is, comparing the safety and effectiveness […]