The adoption of AI in clinical trials holds the potential to revolutionize how therapies are discovered, but the pace of that ...

Design Therapeutics, Inc. announced the initiation of a Phase 1 clinical trial for its gene-targeted treatment DT-216P2 in healthy volunteers, with patient dosing for Friedreich Ataxia (FA) set to ...

Felicione is an independent clinical research scientist and principal investigator. Walk into any drugstore, natural market, or Costco and you’ll find a dazzling array of supplements promising ...

Adaptive clinical trial design represents a modern approach to evaluating healthcare interventions that allows pre‐specified modifications based on accumulating data. This flexible methodology ...

Clinical trials are losing participants. Patient-first design and decentralized models can help fix the dropout problem.

Digital patient profiles and real-world data enhance oncology trial design, patient recruitment, and reduce trial failure risks. Phesi's platform aligns trial designs with real-world data, minimizing ...

Across recent biopharma regulatory updates, a clear industry narrative centers around evolving quality and regulatory expectations. In this episode of PharmTech Drug Digest, we examine how dynamic ...

The burden of diseases does not discriminate, and different populations may react very differently to treatments. To properly test drug efficacy across patient populations, diverse participants need ...

Written agreement from FDA for single-arm, open-label, baseline-controlled registrational trial evaluating composite primary endpoint of improvement in CGI-I and gain of developmental milestone/skill ...

SJ: Amgen has been doing innovative trial designs for well over 5-6 years. We incorporate innovative designs in probably at least 70-80% of our protocols. The therapeutic area where we use them the ...