The clinical trial for a herpes vaccine flouted just about every norm in the book: American patients were flown in to the Caribbean island of St. Kitts for experimental injections. Local authorities didn’t give permission. Nor did the Food and Drug Administration. Nor did a safety panel.
That’s why the trial — run by a startup that has since received funding from billionaire investor Peter Thiel — prompted widespread alarm and censure when it was reported last week by Kaiser Health News.
But in some respects, the herpes vaccine trial isn’t all that unusual. Nearly all drug makers seeking U.S. approval today rely in part on overseas locations and populations to test their drugs, the result of a decades-long push by industry to try to cut costs and speed recruitment of patients. In fact, a STAT analysis found that 90 percent of new drugs approved this year were tested at least in part outside the U.S. and Canada.
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I find STANFORD PROFESSOR Dr. John Ioannidis’ research incredibly inciteful and all Doctors evaluations to be so accurate. From previous CONUS/OCONUS MEDICAL Clinical Research & IT IMS Mgmt. Lead experience, there was then and I see there is a tremendous need today for USA CENTRALIZED, DESIGN & CONTROLLED INFRASTRUCTURES, UNIVERSALLY DEPLOYED, PROVIDE GUIDANCE & ACOUNTABILITY TO THE ENTIRE Clinical Trials and preclinical trials research.
There is not an amount or billions of $ that would unify the entire process unless it is one single infrastructures. Of course where a review safety board, lead investigator and clinical teams have their review and suggest qualified and approved deviation.
With technology mobility, drones, technology adaptability, and remote power source availability there is no excuse to run culture based trials, except where unknown data is not available such as birth date, or other MED-Bio- historical demographic input is difficult and should be then questioned.
In reading the article, most issues are related to trial recruitment, data collection, cultural demographic efforts. All true but we must not disregard, weight of results disparity based on sample collection, environmental extreme conditions, test conducted, chemistries, equipment used, instrument up-keep & historical review to qualification/validation and reporting methods. All are as much contributors as the meals injected prior to test, vitamin regime and any other cultural and biological, emotional impacting aspects.
I actually love how David Thiel’s funded experimental trial was planned. Aside from FDA or SAFETY REVIEW BD. approval, that Herpes trial standardized a lot of inherent geographical, cultural, issues. By providing a hook “Caribbean trip” for otherwise probably afflicted vs. neglected population.
Management would have wasted a lot of time and effort getting approval by either FDA or credentials worried Safety Board anyway. That was easy! Saved on already low standard (0.7%-1.9%) site inspections and providing trial and cohorts were run ethically and test were conducted accordingly, it looks like a promising model to me.