New BMJ Policy Demands Data Transparency From Device Studies

“…it is no longer possible to pretend that a report of a clinical trial in a medical journal is enough to allow full independent scrutiny of the results.”

In short

The British Medical Journal (BMJ) has issued new policy details on the sharing of clinical data, which means that in future it will only publish trials in which the authors commit to making the relevant anonymised patient level data available on reasonable request.

Background

How one might view this new policy will depend very much on one’s perspective. The document can be read in full here, and it certainly doesn’t start well for advocates of the current set-up, the BMJ stating that “it is no longer possible to pretend that a report of a clinical trial in a medical journal is enough to allow full independent scrutiny of the results.”

And it’s tough to argue with the stance that says it a more contemporary view would advocate providing a transparent picture of underlying data if the purpose of clinical publications is to help doctors and patients make the best clinical decisions. The BMJ says these are “qualities that current peer-review processes cannot assure”.

The BMJ piece deals with the issues thrown up by the new policy, endeavouring to clear up issues like what level of detail is “relevant” and who decides what data request is “reasonable”.  It suggests “relevant” data is defined as encompassing all anonymised data on individual patients on which the analysis, results, and conclusions reported in the paper are based.

On “reasonable requests,” the BMJ says it is not in a position to adjudicate, but will expect requesters to submit a protocol for their re-analysis to the authors and to commit to making their results public.

Implications for medical device studies?

Well, clearly there are some. The BMJ defines a clinical trial as “a research project that prospectively assigns human subjects to intervention or concurrent comparison or control groups to study the cause-and-effect relationship between a medical intervention and a health outcome”. Specifically on medical devices it says its policy is aimed most squarely at what the US Food and Drug Administration calls class III devices, “those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.” Examples include pacemakers, stents, and prostheses.

What resonates for us is that by adopting a position that demands greater transparency of data the BMJ is very much in line with current thinking on regulatory approvals. Currently data used to support approvals in Europe is opaque or worse, invisible, even the headline study not requiring disclosure to anyone other than the approving body. That’s a guaranteed change and the BMJ stance will hopefully represent a further brick in the wall of cultural change when it comes to availability of clinical evidence across the piece.
Source: British Medical Journal