EFPIA-PhRMA commitments: Breaking down the basics of commitment 1
13.08.13
It’s clear to me that the pharmaceutical industry needs to do a better job of communicating about its work to the public. It’s a problem I’ve been aware of for some time. It’s why EFPIA has launched its own transparency platform, and it’s why we’ve put out a series of videos (also on the transparency platform) where I try to explain the complexities of clinical trials in a simple way. By enhancing data sharing with researchers, the first of the EFPIA-PhRMA Commitments aims to facilitate legitimate scientific and medical research in a way that will best benefit patients. But here’s the thing: To a lot of people out there – people who aren’t involved in the pharmaceutical industry or the medical field, people who haven’t been following the data sharing debate – basically the average patient – to these people, it might not be so clear what the Commitments are exactly saying. I’m not sure that the terms “patient-level” vs. “study-level” data carry meaning for everyone. With this blog, I hope to explain the first of the EFPIA-PhRMA Commitments in a way that everyone can understand.
What will be shared? Under the first of the EFPIA-PhRMA Commitments, biopharmaceutical companies are prepared to share the following information for medicines and indications that are approved in the US and the EU:
- Patient-level clinical trial data – this refers to individual data that is collected from patients during a clinical trial, and could include things like lab results, demographic data, and details about adverse effects experienced by the individual.
- Study-level clinical trial data – when the different data from many different patients taking part in a clinical trial is brought together, this is referred to study-level data. Study-level data requires researchers to compile and organise the individual patient-level data in an objective way, without analysing the data.
- Clinical study designs and protocols from clinical trials – these documents are the “how to” when it comes to running a particular study. A protocol tells researchers essential information they need to conduct the study such as what drug to give which patient when, what measurements they need to take, and how to deal with adverse events.
Who will you share it with? This information will, upon request, be shared with professionals engaged in legitimate scientific and medical research. This information will not be shared with competitors, in the interests of protecting the huge investment that pharmaceutical companies make into R&D. This is ultimately also in the benefit of patients, as this protects innovation – which is the tool pharmaceutical companies need to deliver new and improved medicines to patients.
Who will decide what legitimate research is and which individuals should be allowed access to data? This will be determined by a scientific review board, to be established by each company independently, which will include scientists and/or healthcare professionals (who aren’t employees of that company). The board will be responsible for reviewing data requests to check that they meet the criteria outlined in the Commitments, as well as the qualifications of the person requesting the data, to ultimately determine if the data request fulfills the aim of serving legitimate medical and scientific research.
