How Mirati Drives Diverse Trials, An RWD/RWE Regulatory World Tour, and More

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.

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TOP 5 READS OF THE PAST WEEK

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#1 Diversifying Site Location, Trial Design, & Community Partnerships To Drive Diversity In Clinical Trials

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.

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#2 No More XPT? Piloting New Dataset-JSON For FDA Submissions

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.

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#3 RWD/RWE In 2023: Regulatory Policy World Tour

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.

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#4 Decentralization: It’s More Than You Think

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.

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#5 The Great Talent Misconception With Large CROs

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.

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MORE TO EXPLORE




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