Wednesday, 5 February 2014

Clinical trials: Clearer rules and better protection for patients

Thousands of clinical trials have not reported their results; some have not even been registered.  Information on what was done and what was found in these trials could be lost forever to doctors and researchers, leading to bad treatment decisions, missed opportunities for good medicine, and trials being repeated. 

All Trials is a campaign to ensure that the results of all clinical trials are registered and reported.  You can read more and sign the petition by following the link HERE!

There is one last hurdle remaining now in clinical trial reform. The Willmott Report will secure better regulation of clinical trials in Europe, for the benefit of all. It has already been approved by the MEPs Public Health Committee and will go before the European Parliament in April. If passed, the proposed regulation of clinical trials will become law. 

You can help achieve this objective by urging your MEP to vote in favour of the Willmott Report on Clinical Trials Regulation when it goes before the European Parliament on 2nd and 3rd April.   

You can find contact details for your MEP on your local council website.  

Here is the text of a letter I have sent to our MEPs.  Please feel free to copy, adapt and paste to make it your own.  I will report responses in due course.

Dear ....MEP

I am writing to urge you to support the Willmott Report on the Clinical Trials Regulation.

I have a personal interest in this matter.  In June 2009, my husband was diagnosed with mesothelioma - a cancer caused by exposure to asbestos, for which there is currently no cure. However, we are confident that one day researchers will find a way to deal with this killer disease.  Research and clinical trials looking for a cure for mesothelioma give us a glimmer of hope on a difficult journey.  

On 3 April 2014 you will have the chance to vote in favour of greatly increasing the transparency of data obtained in clinical trials.   Once the regulation is in force all pharmaceutical companies and non-commercial sponsors of clinical trials in the European Union will have to:

  • Submit a summary of results to a publicly accessible database, within a year of completing the research
  • Submit a summary understandable to a layperson
  • Submit the full Clinical Study Reports of trials when applying to put a medicine on the market
  • Register or publish old trials, if they want to use them to back up applications for new trials
  • Face financial penalties if transparency requirements are not met

These rules will apply regardless of whether the trial was successful, unsuccessful or inconclusive.

Around half of all clinical trials have not been published; some trials have not even been registered. If action is not taken urgently, information on what was done and what was found in trials could be lost forever, leading to bad treatment decisions, missed opportunities for good medicine, and trials being repeated unnecessarily.  

Please will you help improve patient safety, sound science and the advancement of medicine by voting in favour of the report on 3 April?  

I look forward to writing about this important step forward in the regulation of clinical trials on the blog.  With your support, I know it will happen.  

Thank you.

Kind regards,

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