Article | June 22, 2020

Trial Design In The Time Of COVID-19: Complex And Efficient

Source: Advarra

By Luke Gelinas, PhD, IRB Chairperson

Trial Design

The immense negative health, social, and economic impact of COVID-19 demands a wide array of clinical trials evaluating diverse therapies for ameliorating and preventing the disease. To date, government and industry funders have been quick to respond. In a recent webinar, US Food and Drug Administration (FDA) representative Janet Woodcock estimated that the FDA has received over 950 inquiries or proposals for COVID-19 drugs, with 72 of those currently being evaluated and over 200 in the planning stages.

While these numbers are encouraging, Woodcock expressed concern about the ability of the research community to evaluate all of them. “Although we may not run out of patients, unfortunately,” she said, “we may run out of research personnel and time availability to do that in this way of having separate development programs.” Woodcock went on to extol the virtues of “adaptive” and “platform” trials as a way of eliminating less-promising investigational treatments quickly and speeding development of COVID-19 therapies, as exemplified in the current UK-based RECOVERY trial.

Such designs have gained favor recently with regulators and sponsors but remain under-utilized. Moreover, many IRBs may be unfamiliar with reviewing them. The current circumstances give us a chance to reflect on their features and benefits, challenges for IRB review, and strategies for facilitating adoption.

VIEW THE ARTICLE!
Signing up provides unlimited access to:
Signing up provides unlimited access to:
  • Trend and Leadership Articles
  • Case Studies
  • Extensive Product Database
  • Premium Content
HELLO. PLEASE LOG IN. X

Not yet a member of Clinical Leader? Register today.

ACCOUNT SIGN UP X
Please fill in your account details
Login Information
I'm interested in newsletter subscriptions.
ACCOUNT SIGN UP

Subscriptions

Sign up for the newsletter that brings you the industry's latest news, technologies, trends and products.

You might also want to: