A Clinical Trial for the Fda's Clinical Trial Process

Cancer Biotherapy & Radiopharmaceuticals, Vol. 20, No. 6, pp. 569-578, 2005

Posted: 28 Mar 2006

See all articles by Bartley J. Madden

Bartley J. Madden

Center for Advancing Corporate Performance

Abstract

The FDA is tasked with opposing goals which demand tradeoffs - the time and cost of clinical trials to assure safety and efficacy while also encouraging speedy drug advances and affordability. On top of that, there is no feedback mechanism to inform the FDA of the effectiveness of their tradeoff decisions. Dual Tracking is a proposed public policy field experiment that would provide needed feedback information. The proposal is rooted in the right of informed patients to choose among FDA-approved or new, experimental drugs still in clinical trials. All new drugs would continue along the FDA's clinical testing track. On a new track independent of the FDA (but only after successful FDA Phase I safety evaluations), drug development firms would have the option to legally contract with individual patients and their doctors to sell them a not-yet-FDA-approved drug. The contract would require on-going Internet reporting in a specified format of all drug-related experiences. The results of the Dual Tracking process compared to the FDA's process would constitute the critical information now missing.

Keywords: FDA, Dual Tracking, feedback

Suggested Citation

Madden, Bartley J., A Clinical Trial for the Fda's Clinical Trial Process. Cancer Biotherapy & Radiopharmaceuticals, Vol. 20, No. 6, pp. 569-578, 2005 , Available at SSRN: https://ssrn.com/abstract=892430

Bartley J. Madden (Contact Author)

Center for Advancing Corporate Performance ( email )

565 West Adams
Chicago, IL 60661
United States

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