Clinical trials: more transparency, better protection for patients
Pharmaceutical companies and academic researchers will be obliged to upload the results of all their European clinical trials to a publicly accessible database, under draft legislation informally agreed with EU ministers to be put to a vote on Wednesday.
The new legislation, designed to encourage research whilst protecting patients' rights, will replace an existing directive with simpler, more uniform rules. It makes specific provision for low-intervention trials, clarifies the role of ethics committees in the authorisation process and sets out the rules how to obtain informed consent from patients.
Vote: Wednesday 2 April
Procedure: Co-decision (Ordinary Legislative Procedure), first reading agreement
Procedure code: 2012/0192(COD
Press conference Thursday (tbc)