Rule Changes for Data Reporting

By the time this issue of Retina Today is published, it will have been over 3 months since the first trickle of data from the DRCR.net Protocol T study seeped out to the retina community. And yet, we still wait for a full release of information so that we can analyze the data set and make informed decisions about what it all means for clinical practice.

The full release of data from Protocol T is no small consideration. It is likely that its finer points will be debated at meetings and in clinic hallways for months and possibly years to come. There may be nuances and important implications for clinical practice—but the point is, we cannot begin adjusting our practices (if that is indeed necessary) until we can have a dialogue with all the facts out in the public.

There may soon be changes in how data from publicly funded clinical trials are reported. Both the Department of Health and Human Services (HHS) and the National Institutes of Health (NIH) have issued proposals to expand the requirements for publicly reporting data from clinical trials.1,2 A brief overview of these proposed rule changes was published recently in the New England Journal of Medicine.3

As the NEJM editorial points out, these rule changes evolve out of Title VIII of the Food and Drug Administration Amendments Act of 2007, which required the registration and submission of summary results information for certain clinical trials of drugs and devices to ClinicalTrials.gov. Briefly, the proposed rule changes would expand the number of trials and the kind of data being reported.

It is not clear if we could have been saved from the confusion over Protocol T had these rules been in place, although it is unlikely they would have had an impact. The current requirements for results reporting state that results data must be shared no less than 1 year after completion of the trial, and given that Protocol T reports a primary conclusion date of October 2014 on ClinicalTrials.gov (NCT01627249), there would have been no statutory necessity to report any part of the data set. Further, the proposed rules do not change the 1-year time window, nor do they address the need for reporting baseline demographics.

However, these proposed rule changes are at least a step in the right direction. And if the letter of the rule changes would not have changed anything, we believe the spirit of the rule changes (that is, greater transparency) would be of tremendous benefit.

All of us in the research community should take note of the opportunity to comment publicly on the proposed rule changes (the comment window closes on February 19, 2015). This is an opportunity to shape future policy with regard to data reporting from clinical trials, and hopefully save ourselves from confused releases of critical information that matters for how we treat our patients. n