The plan – which still needs to be approved – is designed to encourage drug companies to conduct more trials in Europe while safeguarding patient rights.
According to the European parliament the document – which had not been published when this article was posted – 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.
MEP Glenis Willmott said: "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.”
“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” Willmott added.
"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" Willmott said.
This was Echoed by European Commissioner for health Tonio Borg who said welcomed the agreement and said it "makes the final adoption of this Regulation possible before the end of the European Parliament's current term."
Commissioner Borg also said - although they are not as ambitious as the approach originally sought - the regulations introduces some significant measures that will encourage research in Europe, citing a streamlined application portal, single authourisation procedure and rules designed to give SMEs and academics, more legal certainty as examples.
Other new measures include:
- Improved conditions for conducting multinational clinical trials, which are key for rare and serious diseases;
- Strengthened rules on the protection of patients and informed consent;
- More transparency on the conduct and results of the clinical trial, thanks to a compulsory prior registration on the EU portal; and
- The possibility for the Commission to conduct controls in Member States and third countries to ensure the rules are being properly supervised and enforced.
Drug industry group EFPIA said it "welcomes the agreement on the EU Clinical Trials Regulation concluded by the legislators today. EFPIA believes this new legislative framework will allow for a more harmonised approach with a single submission, streamlined assessment and reduction of red tape. EFPIA sees this as a positive step towards restoring European competitiveness in clinical research in an increasingly competitive global market."
The news follows just 16 days after Pfizer announced its intention to start publishing downloadable, easy to read summaries of trials. At the time the firm framed the move as a way to empower patients, improve transparency and benefit independent researchers.
The move – which will also see Pfizer establish a web portal through which researchers can ask an independent panel for anonymized patient-level data – is in keeping commitments made by Big Pharma rivals like GSK and comes amid renewed calls for drugmakers to publish data from all trials.
Drugmakers’ publication habits were brought centre stage in April 2012 when researcher Peter Doshi suggested in an article in the PLOS their failure to make all trial data available – even the results of failed and discontinued studies – was hampering research.
This prompted regulators to pressure drugmakers to make more data available, which – despite suggestions that industry tried to resist by stoking concerns about patient confidentiality – ultimately resulted in Pfizer’s effort.