Change is underway – What we can learn from the ABPI study on disclosure of industry-sponsored clinical trials
20.11.13
The ABPI-commissioned study, published in the peer-review journal Current Medical Research and Opinion, examined industry-sponsored clinical trials for new medicines approved by the European Medicines Agency (EMA). Among its key findings is the fact that 76% of the 807 trials surveyed had some results disclosed within a year of completion or regulatory approval. This may come as a surprise to some, as previous figures have indicated lower rates of disclosure. It’s a sign of the improved effort being made by the industry.
Another optimistic sign of the progress is the fact that rates of disclosure are visibly rising: Almost nine in ten (89%) of the trials examined had disclosed results by 31 January 2013. We are making changes and that is good to see – because it was time for a change. There is no doubt about that. That’s what motivated my member companies to adopt the EFPIA-PhRMA Commitments this past summer – the plan to improve data sharing put forth by EFPIA and its US sister association, PhRMA. The Commitments were established following the belief that the pharmaceutical industry, which deals with the complexities of clinical trials data on a regular basis, is best suited to efficiently and effectively implement improved data sharing mechanisms. They are designed to safeguard patient privacy; respect the integrity of national regulatory systems; and maintain incentives for investment in biomedical research. By bringing these three points beneath one umbrella, the Commitments work towards public health interests.
With the Commitments taking effect in January 2014, we are now focusing on the concrete steps needed to ensure smooth implementation. Internal discussions on best-practice sharing are underway. To continue its pursuit of open discussion with diverse stakeholders, EFPIA is also organizing a webinar this coming December that will offer the opportunity to hear from leading companies on how they are preparing to implement the principles. The ABPI report shows that we are making progress. As we move forward with the EFPIA-PhRMA Commitments, I hope that we can boost these numbers even more.
When the US government launched clinicaltrials.gov (which has become the default disclosure site), and when industry commited to post summary results, we all made the mistake of not developing a universal “numbering” system. Companies disclose what studies they start, and after completion results may sometimes appear as an abstract followed by the full publication. And then there may be an extension study in which the patients are followed for long-term safety and efficacy. I know this can seem like piece-meal disclosure, but it is a normal and appropriate way to share results as they become available. Not having an agreed “numbering system” for trials make it difficult to track what is what. And when people do meta-analyses, or other secondary analyses, it may be even more confusing. I agree this is a weakness that we have to work on. It is also the reason why different surveys on reporting come to different results: it is easier for the companies themselves to figure out what is what: a survey that does not ask the companies “what is what” is deemed to come up with lower reporting rates.
Having said all this, I think we need to move to the next chapter in this debate. It is clear that (1) transparency about all clinical trials must improve, (2) it must be much easier for researchers to get hold of data and (3) industry can live up to its promises. That is why I am sure our Commitments will work.
