Postmarketing Trials and Pediatric Device Approvals
Pediatrics: April 14, 2014 BACKGROUND: Medical devices can be useful in a variety of diseases, but few devices have been specifically approved for use in children. The 2007 Pediatric Medical Device Safety and Improvement Act was passed to stimulate pediatric device development. The current state of trial evidence underpinning the approval of pediatric devices remains poorly described. […]
An Open Letter to the Cancer Community Regarding Community Clinical Trials
Cancer.gov: 04/10/2014 As you are aware, the National Cancer Institute (NCI) is in the process of combining its two community-based research networks to create a single network that builds on the strengths of the Community Clinical Oncology Program/Minority-Based Community Clinical Oncology Program (CCOPs) and the NCI Community Cancer Centers Program (NCCCP). This network, the NCI Community […]
The Imperative of Overcoming Barriers to the Conduct of Large, Simple Trials
JAMA: April 9, 2014 Randomized clinical trials remain the most reliable means of identifying the drugs, devices, and treatment strategies that will improve human health. There is increasing interest in the possibility that “personalized” medicine can be evaluated in much smaller trials because the average treatment effect is expected to be larger in highly selected cohorts. Smaller, biomarker-driven […]
Pressure Grows for More Inclusive Clinical Trials
Applied Clinical Trials Online: Apr 1, 2014 Health policymakers, academic researchers, and regulators are clamoring for biomedical studies to fully examine how new drugs and medical products affect a broad spectrum of patient populations, including women, minorities, children, and older individuals with chronic diseases. Despite multiple FDA guidances and rules over the years advising sponsors to […]
Closing The Diversity Gap In Clinical Trials
Forbes: 4/09/2014 Clinical trials are at the heart of the process for bringing new medicines to patients. While modern researchers can do more with molecules in the laboratory than ever before, and preclinical analysis of a compound can provide important evidence about its potential value in treating disease, it’s impossible to determine the safety and effectiveness […]
Recruiting and motivating black subjects to complete a lengthy survey in a large cohort study: an exploration of different strategies
BMC Medical Research Methodology: April 3, 2014 Background The effectiveness of multiple innovative recruitment strategies for enrolling Black/African American participants to the Adventist Health Study-2 (AHS-2) is described. The study’s focus is diet and breast, prostate and colon cancer. Methods Promotions centered on trust, relationship building and incentives for increasing enrollment and questionnaire return rate. Of […]
Clinical trials: clearer rules, better protection for patients
Europarl: 02-04-2014 Pharmaceutical companies and academic researchers will have to post the results of all their European clinical trials in a publicly-accessible database, under a draft law already informally agreed with EU ministers and passed by Parliament on Wednesday. The law also facilitates cross-border cooperation to make clinical trials larger, more viable and more reliable, which […]