New Transparency Proposal That Could Change Everything!

Among the many groups that have an interest in improving global healthcare, medical journal editors have enormous influence.

Journal editors have been pioneers when it comes to encouraging research transparency.  In 2004 editors from top medical journals authored an editorial requiring registration in a public trials registry.  This led to an unprecedented increase in the number of trial descriptions available to the public.

They made news again recently by proposing that researchers must publicly share the underlying data gathered to produce the results.  Think about it, raw clinical trial data available to every yahoo with Excel and an axe to grind….or, maybe it is the missing link that will propel medical research by providing data for new hypotheses and improving public trust and confidence in an industry that has taking some hits over the last few years.  For an interesting look at the problem, see Ben Goldacre’s “Battling Bad Science”.

But how will this happen?  Where will it be located?  Who will pay for it?  Can it be misused and/or misinterpreted?  There are many questions regarding the actual implementation and the proposal is open to general comments at by April 2016.

In short, it calls for responsible sharing of trial results data and the protection of trial participants and the rights of investigators and sponsors including the following:

1. Posting results does not constitute prior publication (allowing the data owners to publish elsewhere)

2. Any subsequent analyses must attest they used the data in accordance with the agreed upon terms of receipt (this seems yet to be fully defined or to be defined on a case-by-case basis).

3. Any subsequent analyses must reference the original

4. Any subsequent analysis must include a full explanation regarding how it differs from the original

5. Anyone who wishes to perform subsequent analyses should seek collaboration with those who collected the data

6. Appropriate credit must be given

There are still many details to resolve, and our initial reaction is to be a bit skeptical.  However, it is worth noting that there has already been a significant increase of information and medical research (both academic and industry) has yet to come to a grinding halt!

Image: primus1 / 123RF Stock Photo