Sense About Science have launched a new campaign today All Trials Registered, All Results Reported which joins with Bad Science, Sense about Science, BMJ, James Lind Initiative and the Centre for Evidence-based Medicine to call for action to ensure all trials past and present, for all drugs in current use, are registered; and that the full methods and the results are reported. They have launched a public petition.
Medical Research Charities support the publication of results from research and clinical trials they and others fund to ensure that researchers and clinicians can access the very best evidence base to support their research and make treatment decisions. Publication of data is also important but involves some complicated practical issues that must be addressed – ensuring that data are shared clearly and accessibly in a useful format, while protecting the confidentiality of patients taking part.
AMRC is working with the rest of the medical research community to address these issues and will be seeking your input, as ideas develop.
Clinical trials are an essential step in turning a discovery in a lab into a treatment for patients. New drugs must go through a series of controlled tests to ensure they are safe and effective. Clinical trials, involving healthy volunteers or patients, help us establish whether a drug is safe and how well it works. This POSTnote gives a great overview of clinical trials.
Transparency about how these trials are conducted and the publication of the results is central to research, helping other researchers to learn from this information and make further advances. As well as the overall results of the trial, the detailed data gathered are very valuable for researchers.
Patients want the opportunity to be involved in trials of new treatments. They do this both in the hope that the treatment will benefit them, but also altruistically to improve treatment for others in the future. To ensure this can happen, the results and data from those trials must be shared.
There has been lots of focus recently on improving the availability of data from clinical trials.
The European Medicines Agency has recently announced that it will proactively publish clinical trial results and enable access to full data sets by interested parties. They are setting up working groups to look at some of the practical and policy issues involved in doing this.
GlaxoSmithKline commits to publishing a summary of every drug trial – whether a success or not – on its website and in October 2012 launched a scheme allowing researchers to apply to an independent board for access to the detailed data behind these trials. These data will be provided in an anonymised form through a secure website.
The British Medical Journal also recently announced that from January 2013, they will only publish scientific papers where there is a commitment to make the relevant anonymised patient level data available on reasonable request.
Medical research charities support the publication of results from research and clinical trials and aim to ensure through their Terms and Conditions of awards that the researchers they fund put their research findings in the public domain. (see section 16, Charities & Medical Research)
They also take steps themselves to ensure the results of trials are publicly available – for example Cancer Research UK runs a clinical trials database for patients which aims to list all cancer trials and studies recruiting in the UK – not only those supported by Cancer Research UK. Where trials have reported, they produce a lay summary of results.
However there are some issues that need to be addressed carefully to ensure results and the detailed data behind them can be shared practically and safely:
Practical issues include:
- Trials gather personal information about the individual patients involved – it is important that the data is published with their consent and in a form which protects their confidentiality, removing all identifiable information.
- Results of trials need to be published in a useful format – both how they are made available and how they are presented. The final results of a clinical trial might not be very clear and accessible except to an expert and they may need a lot of time and expertise to interpret. Detailed data even more so. How much information should be made available? Should lay summaries be produced?
- Data from trials can sometimes take a long time to analyse. How long should researchers have to analyse the data before it is published? Where do you start counting from – once a trial has recruited its first patient, there can be lots of unforeseen delays before it gets off the ground and data is collected, where should a sensible deadline be set? And should there be cases where this is flexible?
- How do we ensure all this trial data is findable – pulled together into something searchable so the latest information is actually available and useful for individuals making decisions about treatments or designing new research studies?
And more strategic issues:
- How can we ensure that there are incentives for private investors who fund a large proportion of medical research. Clinical trials are very expensive and we need private investment to fund and deliver them. We need to ensure that companies looking to commercialise treatments should be able to publish the results of their trials without compromising their ability to commercialise these products.
- How do we ensure that negative trial results are published? Results showing that a particular treatment is not effective are very valuable to researchers but they are not the exciting stuff that journals want to publish. If we want results and underlying data to be peer reviewed and made available, there needs to be a mechanism to ensure it can be published.
- Ensuring that this good practice is replicated in other areas of health research. The regulation of devices - including surgical implants, devices to deliver treatments – is governed separately to clinical trials of new drugs.
What are AMRC doing?
Engaging with issues around the publication of research results and data are part of a key strand of AMRC’s work, supporting our members to ensure high standards of research integrity in the work they fund and working to influence the research environment to speed the development of new treatments for patients.
We are currently gathering information from our members to respond to the Science & Technology Committee inquiry. We are also working with other organisations supporting medical research to feed into the discussions in Europe of the new EU Clinical Trials Regulation -just before Christmas we responded to the MHRA consultation on this which will inform the UK government response.