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 regulatory development in Europe, an analysis of patient diversity in oncology trials, and a recent survey by the Avoca Group. Take a look, and tune in for the next roundup in a month!
1. A change to Europe’s guidance on first-in-human trials
As clinical research becomes an increasingly global industry, it’s important to maintain a keen awareness of regulatory landscapes around the world. Last month, CenterWatch reported on the European Medicines Agency’s (EMA) recently-revised guidance for first-in-human trials. The guidance emphasizes matters of particular importance to Phase I trials, such as patient safety. The revisions were informed by the increasing complexity of clinical trial protocols in recent years, as well as by the results of a consultation and workshop earlier this year.
2. Patient diversity in oncology: all about age
It’s rare, these days, to browse clinical research blogs or journals without finding an article or two on patient diversity. Underrepresentation of certain demographics in clinical trial patient populations can cast doubt on how a treatment will affect the general population after market arrival. Much of the coverage of this underrepresentation focuses on ethnicity or gender. But what about age? Last month, we shared an article on the importance of increasing enrollment of older adults in cancer clinical trials. As the majority of cancer patients are expected to be 65 or older within the next few years, enrolling patients of this age group is essential to ensuring that patient populations reflect the typical recipients of the next generation of oncology drugs.
3. A survey on risk management
Every year, the Avoca Group takes the pulse of the clinical outsourcing industry by conducting a survey of sponsors and providers. This year, as reported in Clinical Leader, the survey focused on risk management. In discussing the results, they focus on changes in the landscape of risk and inspections, as well as collaboration between sponsors and CROs and patient centricity. They also offer recommendations for how to respond to challenges in these areas.
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.