31 May, 12 | by BMJ Group
The regulation and governance of clinical research continues to be a key discussion for the clinical research community. Last year, following increasing pressure the government and regulators began to look at ways to reform the system to support and increase the amount of research taking place in the UK.
The good news is that we’re on course to transform health research in the UK.
But there’s still a lot to do to reduce study set-up times, and make sure there’s a collaborative approach to monitor and lead progress and strive for improvements.
These are the findings of our joint report called Transforming the regulation and governance landscape for health research in the UK—written together with the Academy of Medical Sciences (AMS) and the Wellcome Trust.
Our report assessed the government’s progress since an AMS paper published in January 2011 called for the regulation of health research in the UK to be reviewed.
In February this year we, together with the AMS and The Wellcome Trust, met with funders, industry, government, regulators, patient representatives, academics, and NHS organisations to discuss the progress that had been made in reforming and improving the bodies and structures responsible for clinical research.
The meeting also evaluated commitments in the government’s plan for growth, which pledged to improve health research regulation in the UK by setting up a single Health Research Authority (HRA) to simplify the approval process researchers go though when setting up projects.
There were updates on the progress of implementing other new initiatives including the NIHR Research Support Services to assist with improving governance issues and the clinical practice research datalink to assist researchers in accessing anonymous health records. This activity shows that the government’s continued willingness to support life sciences is making progress.
Regulators and government have clearly listened to criticisms from the research community and are improving existing systems. The Medicines and Health products Regulatory Agency (MHRA) has improved site inspections, alleviating the fears that once existed in trial site and quality assurance staff around unnecessary red tape—something which takes up a vast amount of time and energy.
But we need to keep up this momentum. We all want high quality research that also protects the safety of participants. And there remains an opportunity for the Health Research Authority to take a greater role in streamlining the whole process of research.
It’s also clear that patient and public involvement is essential. We’ve not yet integrated patient and public involvement throughout the health research process, and this needs to happen—from involvement in research design right through to regulation and governance processes.
It’s important that everyone in the NHS champions research—at all levels. The NHS is going through a significant period of change. We must use this as an opportunity to highlight the important role of research in delivering health benefits.
We also need to communicate the strengths of UK health research internationally. These strengths can attract substantial economic investment to the UK due to our world class infrastructure and expertise in clinical research.
We’ve got to monitor improvements in health research regulation and governance so we can assess progress.
And we need to develop better data as a community to understand how much, and what types of, health research we are doing. This will enable us to monitor how quickly we are getting studies set up compared with our international counterparts.
Achieving the above goals will take work and time. But continuing to work towards them will benefit both the people running studies and trials and the patients who volunteer to take part in them, saving more lives from cancer and other diseases.
Sarah Woolnough is director of policy at Cancer Research UK, with responsibility for policy development, public affairs, campaigning, and tobacco control. She is responsible for the charity’s policy development across a wide range of public policy issues—from medical research to cancer services policy. Sarah also leads public affairs functions in Westminster, Cardiff, Edinburgh, Belfast, and Brussels and a campaigning function that has successfully campaigned for improvements to radiotherapy treatments and tobacco control measures, including a ban on shop displays of cigarettes.
In 2010 Sarah was seconded to the Department of Health to develop the government’s new cancer strategy—Improving Cancer Outcomes: A Strategy for Cancer—which sets out an ambitious agenda to make our cancer services world class and commits England to saving an additional 5000 lives per year from cancer by 2015.
Sarah sits on a number of national working groups and is a trustee of the Association of Medical Research Charities (AMRC) and health charity Bliss.