Tomorrow WHO will call for a new policy in clinical trial transparency that is transparently absurd, absurdly transparent, and deleterious to the public health.
In its effort to develop worldwide standards of trial registration, WHO formally launched its International Clinical Trials Registry Platform (ICTRP) in April 2005. Tomorrow WHO plans to go public with its proposed final policy on which trials should be registered, and when. The policy will recommend registration of every “interventional study” (i.e. every trial for every intervention, whether marketed or not; whether randomized or not; and whether early phase or late phase).
Give me a break.
WHO wrongly claims that its policy is justified by the need to meet “ethical obligations to study participants.” Those obligations are already met in full, by disclosures to regulators, to independent review boards and ethics committees overseeing each trial, to every clinical investigator participating in each trial, and most importantly to every patient.
Ironically, while not remedying an ethical issue, WHO’s proposal may create one. In its call for registration of exploratory studies, particularly Phase I studies, WHO would fill the registry with vast amounts of data of no medical value. Every user would be compelled to sift this mountain of chaff to find the kernels of useful information; and might mistake the chaff for wheat. Phase I and other exploratory studies serve a narrow purpose and outside that context their results are inherently unreliable. Registering these trials or disclosing their results would at best confuse patients and encourage false hopes. At worst, where non-experimental drugs are being tested for new indications, physicians might inappropriately rely on disclosed trial information to make prescription decisions before confirmatory safety or efficacy trials have even been started.
From an ethical standpoint it is not at all clear what public health purpose is being served by this disclosure, nor which individuals it will benefit.
And then there are the myriad questions surrounding IP issues.
WHO’s policy of registering all interventional studies will make it harder or impossible for research based companies to secure important IP around selection inventions, manufacturing and formulation claims, and important new uses. Without this protection, sponsors may either abandon such research or else increase their precautionary patent filings at a time of high project attrition. This will drive up the cost of development, reduce the number of projects, and delay the progress of products to the marketplace.
The IOM has a better idea. In a recent workshop report they endorsed a more practical and beneficial guiding principle “Avoid reducing the incentive to do clinical research, whether public or privately funded.”
The net effect of the proposed WHO policy is that patients will wait longer for fewer and more expensive medicines, in exchange for a trial registry policy that benefits nobody.
That’s a Geneva Convention we can do without.