EFPIA-PhRMA commitments: Breaking down the basics of commitment 5
13.09.13
The fifth commitment says that “all company-sponsored clinical trials should be considered for publication in the scientific literature, irrespective of whether the results of the sponsors’ clinical trails are positive or negative.” What do you mean by “scientific literature”? Can the general public access this?
Scientific publications and academic journals often publish the results of clinical trials upon completion. True, these academic journals are most commonly referred to by researchers, healthcare professionals, and other specialists – and often they require a paid subscription to guarantee complete access. What’s more, the results can often be quite complicated and presented in specialist terms and jargon. That’s why the EFPIA-PhRMA Commitments also include a point designed to enhance access to clinical study information for the general public (Commitment 2).
Will you really publish negative responses?
Yes – this is one of the primary points of the Commitments and important to creating a better informed healthcare system. When we say “positive” or “negative”, this doesn’t necessarily mean that something particularly bad or good happened in the trial. This just points to whether the expected outcome was achieved (positive result) or not (negative) – whether the hypothesis set forth was met.
“At a minimum, results from all phase 3 clinical trials and any clinical trial results of significant medical importance should be submitted for publication.” – What are “phase 3” clinical trials?
Phase 3 clinical trials are those that are designed to test a potential new medicine’s efficacy – they involve larger trial groups (this could range from a few hundred to thousands of participants). The success of these trials (usually at least 2 are conducted) helps determine whether a drug receives regulatory approval and makes it to the market where it actually benefits patient.
Commitment 5 also specifies “This commitment also pertains to investigational medicines whose development programs have been discontinued.” Why should we care about the results of medicines where testing has been stopped and that therefore won’t ever be on the market?
This information can be useful to researchers and scientists as they continue to pursue advances in medicines development. As in pretty much any part of life, you can learn a lot from mistakes. Sometimes a medicine being tested doesn’t have the desired effect or meet the hoped-for “positive” outcome. But it may have other effects – and these may be useful for other purposes.
This won’t be my last word on the EFPIA-PhRMA Clinical Trial Data Sharing Commitments, or on the topic of responsible data sharing. After the exchange of ideas I was able to take part in at the August 27 event on clinical trial data sharing, I know that discussion and collaboration is the best way towards implementation of a responsible data sharing. And we will continue to contribute to the discussion.
