How Mirati Drives Diverse Trials, An RWD/RWE Regulatory World Tour, and More
Welcome to the Clinical Trial Insights newsletter, featuring strategic insights and expert opinions on designing and running clinical trials. Each edition covers the latest trending articles on ClinicalLeader.com.
In this week's issue, we'll review Mirati's approach to trial diversity, the piloting of Dataset-JSON, regulatory priorities for RWD/RWE, how decentralization is changing the industry, and other popular insights.
If you like what you're seeing in our condensed LinkedIn editions, subscribe to our daily newsletter for full access to exclusive articles, webinars, e-books, and more! Subscribe Now →
TOP 5 READS OF THE PAST WEEK
Creating a diverse and equitable clinical trial requires strategic planning and careful execution — and a balanced approach. Executives at Mirati Therapeutics show how intentional site selection, trial design, and community relationships result in more diverse patient populations for clinical research.
CDISC has developed Dataset-JSON, a new dataset exchange format, to replace XPT. Working with the FDA and industry participants, CDISC and PHUSE are leading a new pilot project to test Dataset-JSON for use in regulatory submissions as well as other dataset exchange scenarios.
Building trust and confidence in RWD/RWE requires open dialogue and collaboration to ensure we all walk the same path toward a future-ready regulatory framework. In this article, experts from Bayer review what the industry considers RWD/RWE priorities for the year, as well as current efforts being taken within each region around the globe.
Recommended by LinkedIn
Decentralization is not only a breakthrough in trial design but also in the larger field of scientific research, and it represents a paradigm shift in the digital world. Garri Zmudze shares his thoughts on how decentralization will drive patient empowerment, trial accessibility, and new fundraising models.
Large CROs have a vast pool of resources and a subset of amazingly talented people. However, the decision to select such a CRO on the concept that they have access to the best talent, and the hope that those resources will be assigned to your study, is flawed.
MORE TO EXPLORE
- How Can Non-Randomized RWE Studies Complement RCTs?
- How Generative AI May Transform Content Development In The Life Sciences
- A Shift Toward Trial Site Management Organizations: Trends And Implications For Sponsors
- Advancing Use Of Patient Evidence In Decision-Making
- Gilead Addresses Health Equity In HIV Prevention Challenges By Designing Next-Gen Clinical Trials, Aiming For New Options
Clinical Leader is an online community serving professionals in the clinical research space. We share insights and best practices — from industry experts — to help sponsors and CROs tackle the biggest challenges they face in designing and running clinical trials.
To get the most out of our offerings, join the Clinical Leader community.