On Monday the UK Government published its response to the House of Commons Science and Technology Select Committee inquiry into clinical trials. The Committee had made some good suggestions, especially around making “old data” from past clinical trials available.
The Government’s response to the Science and Technology Committee’s recommendations on past trial data is weak – it does not seem to have grasped the importance of having access to data from past trials, nor that some companies (e.g. GSK, LEO Pharma, Roche) have committed to providing access or are already doing so. Many of the treatments in use today are based on trials done 10-20 years ago, and without access to all the data from those trials, doctors and regulators cannot make the best treatment decisions.
The Government did say it:
- Supports prospective trial registration – The HRA has made this a requirement in the UK from 30th September 2013.
- Supports publication of summary results and Clinical Study Reports (CSRs) where available. However, we are concerned by the ambiguity in a part of the Government’s response relating to CSRs in which they say “it important that there is clarity about the data that should be included in CSRs to ensure that trial sponsors as well as the public can be reassured.”
- Will ask the HRA to undertake an audit of completed studies to more fully understand publication rates in the UK and look for further ways to monitor compliance to publish within the agreed conditions of REC approval.
- Supports the amendments to the Clinical Trials Regulation were which adopted by the European Parliament in May 2013. This includes an amendment that states that data in CSRs is not commercially confidential after marketing authorisation.
The Clinical Trials Regulation is currently being discussed in Europe in Trilogue meetings between the European Council, Commission and Parliament and AllTrials has been encouraging its European supporters to write to their countries’ health ministers, asking them to vote to keep the amendments in the final Regulation.
Also on Monday, good news from the Department of Health who released a statement stating its support for the AllTrials campaign. It said:
“The government supports the call for more transparency in clinical trial data. Transparency is important for patients, the public, researchers and the NHS, and can be achieved through ensuring that all clinical trials are registered on a public database such as the EU Clinical Trials Register. This means that everybody can see what trials are ongoing, the results of all clinical trials are published, and data from all clinical trials are made available.”
The full statement can be read here.