Re: Tamiflu: 14 flu seasons and still questions
Adam Jacobs fears that RECs may not be able to enforce the type of up-front commitments to publish that I recommend by means of an agreed, boiler plate, non-negotiable statement.
His blog clarifies why he has difficulties. He imagines the commitment to publish is made by the individual academic researcher. In fact, I view the committment as being required by the pharma company which is funding the research.
If the company has not, one year after ending the study, made the publication arrangements it agreed to (to the REC which gave the original approval, on this basis), then the REC should be duty bound to alert the HRA.
The HRA should then send out a notice to all RECs that pharma company X is in breech of its agreement. New studies by company X would be blocked, and existing studies would be recommended for review and possible suspension.
Janet Wisely, on behalf of the HRA, may already be moving in this direction, having earlier written to the BMJ stating:
"We will do this (ensuring compliance) by routinely reviewing the final report to identify any failure to comply with researchers' declared intentions to publish, register or make study information or tissue available one year after the final report. We are currently exploring how best to implement these improvements and safeguards, and expect to establish a new system early in 2013."
Let my recommendation to the HRA be clear:
1. Specifiy what you want the initial commitment to say. Make it as watertight as possible. Make it part of the REC Standard Operating Procedure (in the handbook).
2. Make compliance a matter explictly for the pharma company in CTIMS trials.
3. Make explicit the sanctions the HRA will enforce, and make them onerous.