Pharmaceutical companies and academic researchers will be obliged to upload the results of all their European clinical trials to a publicly accessible database, under a provisional agreement reached between Parliament and Council of ministers on EU rules on clinical trials of medicines.
The draft, designed to encourage research whilst protecting patients' rights is to replace an existing directive with simpler, more uniform rules. The new text makes specific provision for low-intervention trials, clarifies the role of ethics committees in the authorisation process, and details how to obtain informed consent from patients.
"For too long, unflattering studies on new medicines have gone undisclosed. Around half of all trials are never published, usually those with negative or disappointing results. It is vital we know about negative outcomes, otherwise trials can be conducted repeatedly before it becomes public knowledge they are ineffective, or even dangerous", said Glenis Willmott (S&D, UK) who is steering the legislation through Parliament.
“The transparency requirements are part of a wider piece of legislation which will streamline the rules on clinical trials across Europe, facilitating cross-border trials to enable larger, more reliable trials, as well those studying rare diseases. The improved rules should ensure Europe maintains and increases the number of skilled jobs in clinical research, whilst continuing to improve treatments for patients” Ms Willmott added.
The new law features simplified reporting procedures, and empowers the European Commission to do checks. Once a clinical trial sponsor has submitted an application dossier to a member state, the member state would have to respond within fixed deadlines.
MEPs amended the draft to improve transparency, by requiring that detailed summaries be published in a publicly accessible EU database, with full Clinical Study Reports published once a decision on marketing authorisation for the tested drug is complete or the request for marketing authorisation has been withdrawn. Fines would be imposed on sponsors who do not comply with these requirements.
"We are determined to finalise this before the European elections in May. This legislation will set the global gold standard for transparency in clinical trials, and I call on all EU governments to support the agreement" Ms Willmott said.
The legislation will need final approval from the European Parliament.