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 look at the potential for home-based clinical trials, the implications of the FDA’s interchangeability guidance for biosimilars, and an overview of some of the biggest trends in clinical research today. Take a look, and tune in for the next roundup in a month!
1. Better patient engagement through home-based clinical trials?
As patient engagement becomes a hotter and hotter topic in clinical research, industry thinkers are conceiving of new ways to cater their research to the needs, desires, and priorities of the patients. One manifestation of this is home-based clinical trials, whereby certain aspects of a trial are conducted in the patients’ homes, reducing the need for site visits. Advocates hope that, by cutting down on travel demands and minimizing the impact on patients’ day-to-day lives, this approach can entice more patients to enroll in clinical trials, thus improving patient recruitment. Applied Clinical Trials recently ran an article discussing the various considerations, such as those related to finances, safety and effectiveness, and more, involved with home-based clinical trials.
2. Examining the challenges of biosimilar interchangeability
From both a business and regulatory standpoint, biosimilar development has generated much buzz and debate in the clinical research industry. In a column for Clinical Leader, biosimilar expert Anna Rose Welch discusses the FDA’s recently-released draft guidance on biosimilar interchangeability, which, she notes, has been surprisingly well-received in the biosimilar field considering the sensitivity of the subject. The guidance has, however, sparked discussion of a number of interchangeability challenges pertaining to record keeping, real-world evidence, and other areas, which Welch details in the column.
3. Clinical trial trends, from new tech to study design and beyond
Clinical research is rapidly evolving, owing to technological developments like eClinical software, as well as to more philosophical factors such as new approaches to study design. Last month, BioPharma Dive discussed a number of these influential forces in an article on the major trends changing the ways clinical trials are conducted. The list involves some items, such as patient centricity and wearables, that are likely familiar to most regular patrons of the clinical research blogosphere – but also some that readers may not have heard much about yet. One thing they all have in common: all are presented as ways of making the increasingly expensive drug development and clinical research process more time- and cost-efficient.
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.