EMA Enlists GPs’ Help To Generate More Real-World Evidence
The generation of more real world evidence on medicines is one of the aims of a newly announced collaboration that will see family doctors playing a bigger role in providing data for the European Medicines Agency to use in its drug evaluation activities.
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Biopharma companies are reluctant to rely on real-world evidence trials, but while uncertainty remains about how these novel studies will be accepted, US and other regulators are encouraging drug developers to take a chance – and some have taken on the challenge.
Pharmacoepidemiologists and statisticians at the European Medicines Agency used databases of electronic healthcare records to support decision-making by its scientific committees using real-world evidence.
The two countries want the European Commission’s proposals to be more closely examined for their possible negative effect on pharmaceutical investment decisions. The industry federation EFPIA says it is surprised more EU member states aren’t taking the same stance.