Oncology trial design is being rewritten in real time, and protocols written even 12 months ago are starting to look out of ...

As cell and gene therapies (CGTs) continue to advance, they have unique developmental features that may require innovation in a clinical trial setting, the authors of a recent paper explained.

Confirmatory Phase 3 trial to commence prior to BLA grant under Accelerated Approval Program in the U.S. and Conditional MAA ...

Creating a Proxy for Baseline Eastern Cooperative Oncology Group Performance Status in Electronic Health Records for Comparative Effectiveness Research in Advanced Non–Small Cell Lung Cancer ...

The US Food and Drug Administration (FDA) on Wednesday finalized guidance for sponsors on interacting with the agency on complex innovative trial designs (CID) for drugs and biologics. The nine-page ...

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 ...

Recent Trends and Patient Outcomes of Phase I Trials: A Single-Institution Experience in the Era of New Therapeutic Agents This study reviewed all industry-sponsored phase I clinical trial protocols ...

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 ...

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 ...

This activity was supported by contracts between the National Academy of Sciences and Advanced Regenerative Manufacturing Institute; Akron Biotech; Alliance for Regenerative Medicine; American Society ...