After last week’s event on clinical trial data sharing, I am more convinced than ever that communication– with a variety of stakeholders and the broader public – is the key to finding the best way towards a responsible transparency. An open exchange of opinions and ideas is needed to raise and answer the tough questions – and there are many difficult questions to consider when discussing a complicated issue like clinical trials data sharing. With that in mind, I’m today continuing my series of blogs on the EFPIA-PhRMA Commitments – our industry’s proposed solution to a means of clinical trial data sharing that will best benefit patients and public health.
How will you ensure that companies are following through on the Commitments?
The fourth of the EFPIA-PhRMA Commitments is dedicated to affirming the procedures that each of EFPIA and PhRMA’s member companies is committing to follow for clinical trials data sharing. Following the fourth commitment, companies will certify on a website – open to the public – that they have established policies and procedures to implement the Commitments.
EFPIA will make it binding for its member companies to implement the commitments. This will be done through a revision of the EFPIA Code, or maybe as a new one. I will wait a few months for input from all stakeholders, and for more practical experience in companies, before drafting the binding rules.
Will a common set of guidelines for implementation of the Commitments be established?
Not every company will have the same policies and procedures for implementation. Pharmaceutical companies are complex, global organisations with diverse procedures, research projects, and databases – and it is up to each company to know how to best implement the Commitments, based on the systems and data they have in place.
The Commitments are meant to serve as a common baseline for all EFPIA and PhRMA member companies to follow to improve sharing of clinical trials data. By bringing so many companies together under the Commitments, we’ve accomplished something that is – in my view – quite big. Getting such a diverse group of companies to agree is not easy. Some companies may choose to share more than others; the processes that each company implements to improve data sharing may be different. But we are in agreement that responsible data sharing supporting public health initiatives is a must. On that point, there is no argument.