The history of the clinical trials process

Readers with an interest in how we got to today’s clinical trials processes for evaluating new drugs for the treatment of prostate cancer and other diseases might be surprised by what’s in an article in this week’s New England Journal of Medicine.

Rankin and Rivest provide a brief but illuminating history of some of the earliest types of clinical trial process (as far back as the late 1500s). They also address the relationship between such trials and formal permission (usually by a ruler or someone acting on a ruler’s behalf) to promote a particular drug for a specific clinical use.

You would be wrong to think that the close modern link between drug development, drug approval, and drug marketing was any type of 20th Century phenomenon — although it has obviously evolved significantly since the thalidomide disaster across much of Europe and other countries in the late 1950s. A disaster that the U.S. Food & Drug Administration was able to prevent here in America.

2 Responses

  1. The Thalidomide disaster doesn’t apply to advanced prostate cancer. Those of us with the advanced cancer aren’t capable of fathering children anymore, and we have virtually nothing to lose in trying a new drug for Stage IV advanced metastatic prostate cancer.

    But I personally would never allow them to put me on a trial where there is any possibility of receiving a placebo instead of the trial drug, as a “control.” On a placebo, the cancer would be uncontrolled, and there would be no physical benefit to myself or anyone else by allowing the cancer to progress.

  2. Dear Eric:

    I don’t think anyone has done a trial in advanced prostate cancer for years in which patients only got a placebo. Almost every trial that I can remember since about the late 1980s has compared the investigational therapy to “standard care” + a placebo (but the placebo was only used so that neither the doctors nor the patients knew what they were getting, which is an essential component of a randomized, double-blind trial).

    And, with respect, what happened related to thalidomide is at the very heart of how all drugs get tested today before they can be approved.

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