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Decentralized Trials: Stakeholders Press FDA On Design Flexibility, Role Of HCPs, Harmonization

 
• By Brenda Sandburg

Dozens of stakeholders weigh in on FDA’s draft guidance for decentralized clinical trials. They question having a higher bar for DCTs, the new requirement for a task log, and the presumption data collected in these trials may be more variable than that from traditional trials.

Clinical Trials word cloud
Stakeholders offer advice on how FDA can improve its draft guidance on decentralized clinical trials • Source: Pink Sheet/Shutterstock

The biopharmaceutical industry and clinical research groups offered a slew of suggestions to the US Food and Drug Administration on how to improve its draft guidance on decentralized clinical trials. They called for the agency to allow flexibility in trial design, clarify the role of local health care providers, and work with other regulatory authorities to harmonize use of DCTs.

The draft guidance, issued in May, provides advice on how to design and implement DCTs, the responsibilities of sponsors and...

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Animal Testing: US And EU Regulatory Support Grows For Alternatives, But Validation A Hurdle

 
• By Eliza Slawther

In this first of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet how the use of alternatives to animal testing in drug development is gaining traction and discusses the challenges that exist.

HHS Wants Employees (And Public?) To Report Diversity, Equity And Inclusion Discrimination

 
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HHS Wants Employees (And Public?) To Report Diversity, Equity And Inclusion Discrimination

 
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