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Date:
05-06-13

Author:
Empower

A clearer picture for clinical trials

A clearer picture for clinical trials

Britain used to be a leading light in drug development, pioneers in discovering new compounds and life changing treatments. As part of that combination we were also a leading force in drug trialling; but this is no longer the case. To put this into its wider context, the number of drug trials started in Europe has dropped by a quarter since the mid-2000s, and that was from an already declining base.

This decline obviously has a direct effect on the number of new treatments making it to patients. As our campaign moves forward and we have had an increasing number of informed conversations with key stakeholders from pharmaceutical, regulatory, political and patient groups, we have been building a more detailed picture of the log jam that holds back drug development.

Part of the bureaucratic system that has had a cultural impact on the conducting of clinical trials has been an EU Directive that started out with laudable aims. It was designed with the valid goal of protecting patients from excessive risks when trialling experimental medicines and treatments. However, it is widely acknowledged now that the rules went too far and were arbitrary in nature.

Last week Glenis Willmott, a British MEP, has led the charge to draft new rules to simplify reporting procedures and enhance the transparency of trial data. 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 authorisation is complete.

This is a brave decision as it may not prove popular with everyone; I fully acknowledge the administrative burden that will come with making all this data available in a coherent form. But if it speeds up research in the long run then the toil will be worth it. The EU Commission will need to be even handed in dealing out fines (as per their new powers) to those who do not comply immediately – one can never turn a tanker around quickly. 

The move to have low-risk clinical trials covered by a general compensation system is interesting – again it should boost industry confidence to invest.  For other clinical trials, the sponsor would be deemed liable for damages, but could make use of “a national indemnification system which all Member States should set up to reduce high insurance costs.” This is of particular interest to the Empower campaign – the Halpin Protocol (under consultation) focuses on this objective. Professor Sir Peter Lachmann, a good friend to Empower, is leading the consultation process and will be looking at this area specifically. I will continue to update you on his progress.

Speaking of friends we have had a series of excellent meetings with Joining Jack, the Duchenne Children’s Trust and Teenage Cancer Trust over the past couple of weeks. We have so much common ground and I look forward to working with them closely. I hope through Empower: Access to Medicine we can bring the patient community together to fight for a common purpose.

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