When addressing a complex topic like clinical trials, it’s easy to get lost in the fine points – especially for people like myself who have been in the pharmaceutical industry for many years. We’re passionate about the details – and sometimes forget that these can be meaningless to people without such an in-depth background in pharma. But I’m trying to simplify, as I continue to explain the EFPIA-PhRMA Commitments to Clinical Trials Data Sharing. This week I’m looking at the second commitment, which focuses on enhancing public access to clinical study information. The aim is to help patients and healthcare professionals better understand clinical trials results – which are used by the European Medicines Agency (EMA) and the Food & Drug Administration (FDA) in the US to approve new medicines and to decide whether approved medicines are still safe to keep on the market.
What will be shared with the broader public?
Biopharmaceutical companies will make available – at the very minimum – the synopses of CSRs (clinical study reports) for clinical trials in patients submitted to the FDA, EMA or national competent authorities of EU member states. This will be made available after approval by the EMA or FDA of a new medicine – or approval of a new indication (a different, new use for the medicine) for an already approved medicine in the EU or US.
What information is included in a Clinical Study Report? Will all of this info be available?
CSRs are enormous documents containing huge amounts of information, including: trial design; how the study population was selected; type and dosage of treatment administered; efficacy and safety variables; methods of analysis; summaries of adverse events; individual patient changes; and more. All patient results, from blood pressure to cholesterol levels, are listed from every doctor’s visit. With all this detail, a full CSR can contain thousands of pages. Much of this information is very sensitive and CSRs will be redacted accordingly to protect patient privacy; publication rights; and confidential commercial information.
Will full CSRs ever be made available?
In keeping with the first of the EFPIA-PhRMA Commitments, requests for full CSRs from qualified scientific researchers for legitimate research purposes will be considered and evaluated on a case-by-case basis. Full CSRs, including patient-level and study-level data (see my blog on Commitment 1 for more information) may be released on an exclusive basis to qualified researchers with a legitimate research plan.
When will this information be made available?
EFPIA and PhRMA member companies will make available CSR synopses filed with regulators on or after January 1, 2014 – this is when the EFPIA-PhRMA Commitments go into effect.