EFPIA-PhRMA Commitments

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EFPIA-PhRMA commitments: Breaking down the basics of commitment 3

29.08.13

The debate on clinical trials data sharing so far has focused largely on a broad, general transparency – on making CT data available to the more general public. But there is another, more specific group of individuals whose interest in the results of clinical trials is even more pressing – the patients who take part in the trials themselves. Sharing trials results with the patients who participate in them is the aim of the third of the EFPIA-PhRMA Commitments, and in my view it is one of the most important.

Don't patients who participate in clinical trials already find out about the results?

Of course, “informed consent” is part of any clinical trial and helps inform and protect patients who take part in clinical trials. Through the informed consent process, researchers provide potential and enrolled participants with information about the clinical study. This ensures the person understands the potential benefits and risks of taking part in the study, as well as alternatives. At the end of a study, patients can be informed of the end result – but not necessarily of all the details of the study itself (i.e. the information contained in a clinical study report, CSR – see my blog from last week for more information on CSR’s and what they contain).

What will be shared with trial participants according to the third EFPIA-PhRMA Commitment?

The third of the EFPIA-PhRMA Commitments is dedicated to providing all clinical trials participants with a factual summary of the trial’s results. The goal is to help inform and educate patients about the clinical trials in which they are participating.

Patients are, after all, our most valuable stakeholder, as I’ve said many times before. My industry wouldn’t exist without them. Their input is essential – and to get their input, we need to be sharing this information with them.

Richard Bergström was appointed as Director General of the European Federation of Pharmaceutical Industries and...