Welcome to the Medrio Monthly News Roundup, in which we brief you on a sample of events and developments taking place around the industry. This recurring update functions on popular demand – the stories in this post come from the articles in our social media feeds that garnered the most attention from our readers and followers. Your likes, clicks, and retweets decide which stories make it beyond your newsfeed and onto our blog.
This month, we bring you: a change in thinking on the risk of false positives in clinical trials, a new initiative involving academic researchers and the NIH, and a discussion of the challenges involved with ensuring subject compliance. Take a look, and tune in for the next roundup in a month!
1. Rethinking the maximum risk of false positives in clinical trials
Randomized clinical trials have been largely successful in preventing false positives from contaminating research conclusions. But scientists at MIT and Mayo Clinic have developed a new framework that incorporates patient input into how high a risk of false positives should be acceptable in the drug approval process. The framework approaches the issue on a case-by-case basis, reasoning that, depending on factors such as the severity of the disease being treated, patients may be willing to accept a higher risk of false positives if the alternative is a potentially life-saving treatment failing to be approved. The proposal was released as part of a study in JAMA Oncology that the co-authors have dedicated to one of the scientists, Daniel J. Sargent of Mayo Clinic, who passed away last year.
2. A shot in the arm for academic clinical research
Academia is home to some innovative and promising medical research. But clinical trials at universities face challenges in translating their research to approved medical products. That’s why, two years ago, the NIH established the Research Evaluation And Commercialization Hubs (REACH) network to provide the resources necessary to turn academic clinical trials into new treatments on the market. The network takes a three-pronged approach to its mission that includes funding, training, and access to technology – areas that people involved with the program see as major pain points for academic research. STAT News ran an article last month promoting the program.
3. How to improve subject compliance in clinical trials?
We recently shared an interview with the Senior Director of Clinical Science at Takeda on a new tool designed to increase subject compliance in clinical trials. In the interview, he 3. discusses the importance of subject compliance in reaching an accurate determination of a treatment’s safety and efficacy profile. He also explains why traditional methods of ensuring compliance are imperfect, and how the new tool, an artificial intelligence platform, aims to improve upon those methods.
That’s all for this roundup! We’ll have three more stories for you next month. In the meantime, check out this blog every week for new insights into EDC and clinical research.