Randomized Consumer Trials
View Presentation *Scott Zeger, The Johns Hopkins University Keywords: Every useful medicine has a therapeutic window, a dosing regimen in which it provides greater benefit than harm. Society faces a dilemma in its development of drugs for chronic conditions. We approve drugs use after studies with 1,000-10,000 persons. Then, a successful drug is used by 1,000,000 to 10,000,000 persons. A drug that harms 1 in 1,000 or 1 in 10,000 persons goes undiscovered in controlled clinical studies. As has been demonstrated for chronic use of non-steroidal anti-inflammatory drugs (NSAID), it can also go undiscovered through decades of general use. Dr. Zeger’s talk discusses one potential solution to this dilemma, randomized consumer trials (RConTs). The idea is to create an incentive for larger, simpler, randomized treatment trials after initial drug approval. The design and analytic issues with an RConT are discussed. The ideas are illustrated with designs for a vaccine and new NSAID trial.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC