Editorial: A Clinical Trial for the Food and Drug Administrations's Clinical 569 Trial Process

Abstract

The U.S. Food and Drug Administration (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 ongoing 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.