Agreed. It isn’t clear what the issue is here.
If the research protocol states 3 years of data collection it’s technically unethical, without submitting an amendment, to collect data beyond 3 years as the patient hasn’t agreed to this. Sure, in hindsight the data should have been collected for longer but at the time of study design 3 years probably seemed appropriate. It’s really difficult to say how long to follow up - forever? Sure, but would be financially unfeasible.
We do have a yellow carding system in the UK - the medicine and health regulatory authority (MHRA) run this and it’s for submission of adverse drug reactions as well device issues. But again, not sure how helpful it would have been for the instances of participant death after 3 years. Seems harsh on the doctors who carried out the research, unless I’m not reading this correctly.
The doctors who carried out this research are, it sounds, blatantly in the wrong, for they withheld the data that appears to make clear that stents have worse outcomes past year 3 until after the guidelines were written while they had already gathered this data before the guidelines were written.
Sure they cannot openly share all their data because it is private, but it is very suspect that they do not share the external review that found them at fault
As Prof John Ioannadis points out in the article, there are wide systemic issues in the trials and guidelines process.
This depends on jurisdiction of course, but in a lot of cases you can't share data that wasn't consented for that use originally - anonymized, de-identified, or otherwise.
Chasing down previous patients for retrospective consent would be difficult to impossible.
