Takeaways From FDA & OHRP's Draft Guidance On Informed Consent, How Curadev Tackled Site Selection Without A CRO, and More
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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In this week's issue, we'll review the FDA and OHRP's joint draft guidance on informed consent, how hybrid trials offer a patient-centered solution for rare disease patients, what FDA And EMA discussion papers reveal about AI in clinical research, how Curadev tackled site selection without a CRO, and other popular insights.
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TOP 5 READS OF THE PAST WEEK
The FDA and OHRP have jointly issued a new draft guidance about how sponsors, investigators, and IRBs should structure and present informed consent documents to clinical research participants. Elizabeth Oestreich and Thomas Berry of ELIQUENT Life Sciences provide an overview.
Globally, millions of people suffer from over 7,000 rare diseases, yet clinical trials often fail to recruit enough patients because they can't reach sites or have other challenges that make it hard to participate. Todd McGrath of Medical Research Network shares how hybrid trials offer a patient-centered solution.
领英推荐
Curadev COO and CFO Manish Tandon discusses the company's first foray into site selection (all without a CRO), covering a site’s influence on patient recruitment and centricity as well as digging into the advanced planning that allows partnerships like these to form.
Although the EMA and FDA differ in their approach to the ethics of medical applications for AI, they share common concerns. Castor shares how having a comprehensive understanding of regulatory perspectives on AI ethics will prove invaluable for researchers evaluating the integration of AI in trials.
For small clinical-stage companies, developmental risk management plans (DRMPs) are not a regulatory requirement but a strategic imperative to proactively manage risks. Kamlesh Prabhu of Omega Therapeutics shares why DRMPs should be prioritized.
MORE TO EXPLORE
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