EPHA member – Cancer Research UK – presents its policy recommendations to reform the Clinical Trials Directive.
A new policy briefing by Cancer Research UK, ”Supporting research, protecting patients” has been launched during a meeting in the European Parliament.
The briefing contains a number of key recommendations to reform the Clinical Trials Directive, amongst them:
– option of coordinated assessment procedure for multi-national clinical trials
– restriction of ”investigational medicinal product” designation to therapies that are genuinely novel and investigational
– risk-based approach, ideally with the onus on the Sponsor to justify the assessement
– limitation of ”substantial amendments” to avoid over-reporting
– sponsorship of CTDs by multiple organisations should be allowed in order to share risk and responsibility
The proposed changes could make the CTD more efficient for researchers, and speed up the process without compromising patient care and safety, or the outcome of the trial.
Cancer Research UK event in the European Parliament
Chaired by Glenis Willmott MEP (S&D, UK) and designed as an information session for MEPs, their assistants, and other interested stakeholders, the event brought together the views of patients, academics, scientists, industry and policy-makers. Particular attention was given to the role of academia in clinical trials and the impact on patients.
The event showed how the current Clinical Trials Directive (CTD) has created burdensome bureaucratic processes that are not only very costly and time-consuming but effectively hinder the implemention of clinical trials, especially international (multi-country) trials that would benefit the study of rare diseases. Instead of contributing to making drugs safer and harmonising regulation and conduct across the EU, the Directive has created an increasing amount of red tape, e.g. the requirement of classing nutrients and licensed drugs as ”investigational medicinal products”, which implies having to log information on suspected adverse reactions multiple times. National drugs authorities are also interpreting the Directive in different ways.
Cancer Research UK Chief Scientist Peter Johnson underlined that if the Directive does not get amended it could threaten medical research in Europe as the current process is too complex and expensive and inciting drugs companies to go elsewhere.
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Next steps
Following a public consultation in 2011 (EPHA’s response), the Commission has scheduled adoption of the legislative proposal for 2012, and EPHA will continue to monitor the process throughout the year.
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For further information
– Clinical Trials – Major Developments, DG SANCO
– Cancer Research UK website
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