EFPIA continues its active involvement in the important issue of responsible clinical trial data transparency and welcomes the opportunity afforded to comment on the EMA draft Policy 0070 on Publication and access to clinical-trial data (EMA/240810/2013, referenced as ‘draft Policy’ in these comments).
EFPIA recognises the potential scientific and public health benefits of providing greater access to information from clinical trials. Biopharmaceutical companies are indeed committed to advancing public health goals through responsible sharing of their clinical trial data in a manner which is consistent with the following imperatives:
• Safeguarding the privacy of patients;
• Preserving scientific rigor and the trust in the regulatory systems; and
• Maintaining incentives for investments in biomedical research.
Download the full EFPIA comments here.
An executive summary of the EFPIA submission is available here.