September heralds two important events in the continuing discussions around clinical trial transparency. This month we have both the closing date of the European Medicines Agency (EMA) consultation on ‘Publication and access to clinical-trial data’ and here in the UK we also expect the report from the Science and Technology Committee inquiry into clinical trials and disclosure of data. But to those of us who are involved in discussions around clinical trial transparency the summer has been far from quiet in this area.
Here at the ABPI we have not only launched our Clinical trial disclosure toolkit. We have also brought together wider stakeholders with our Innovation Board at a partnership forum to discuss both ‘clinical trial transparency’ and ‘patient and public involvement in research’.
It is essential that we continue to engage the public and patients throughout the research process. Without patients taking part in medical research we can’t develop innovative new medicines and treatments for disease. So it is crucial that we do not lose the confidence of those who already participate, nor deter others from taking part in research. For me, calls for transparency should focus much more on the needs of these research participants, such as the information we provide before and after a study, fully informed consent and the provision of lay summaries of the results of the research results.
Therefore, I welcomed the inclusion of the importance of sharing these summary results with clinical trial participants in the ‘Principles for responsible clinical trial data sharing: Our commitment to patients and researchers’ launched in the summer by the wider international pharmaceutical community represented by the European (EFPIA) and American (PhRMA) trade associations.
As I mentioned in my last blog, “The purpose of clinical trial transparency needs to be clear – is it communication of the occurrence and results of trials to the general public or about facilitation of further research for scientists?”.
I’m pleased that we’re starting to really address both of these questions in partnership with the wider research community. The on-going dialogue to discuss, debate and tackle the issues surrounding transparency has led to a coalescing of views from all stakeholders towards a shared vision of what ‘responsible data sharing’ could look like. This was demonstrated to me by the AllTrials campaign stating that they are not calling for individual patient data to be made publicly available. I think we can all agree researchers have a commitment, both ethical and legal, to protect patient privacy.
As we move into autumn, I’m happy to say there are working groups, both national and international, who are settling down to work collaboratively to tackle the question of ‘how’ not ‘if’. Here at the ABPI we’re working with the PSI (Statisticians in the Pharmaceutical Industry) to develop a workshop looking at the technical standards for data sharing for old, current and future clinical trials.
Dr Bina Rawal
Director of Research, Medical and Innovation