Science and Technology CommitteeWritten evidence submitted by INVOLVE

Key Points

Public involvement in research is critical to its quality and relevance but also to ensuring that it is conducted to the highest standards and in the public interest

Lack of disclosure of clinical trial results has been a perennial issue of concern to patients and the public.

Reducing research regulation is equally important to patients but not if it is at the expense of issues of importance to them

We welcome the work being done by the Health Research Authority (HRA) to address issues around bureaucracy but also transparency of reporting etc. We welcome the HRA’s forward-thinking attitude to patients and the public.

All research funders should commit to making sure that research participants receive the results of trials they have taken part in as well as how the research has improved knowledge into their condition.

We welcome the work that NIHR is doing in partnership with INVOLVE and others to make information on open trials and the results of trials more openly accessible through the provision of plain English summaries.

The UK Clinical Trials Gateway (UKCTG) is a potentially important vehicle for making clinical trial results and data more publicly available.

INVOLVE welcomes the opportunity to submit written evidence to the House of Commons Science and Technology Select Committee inquiry into clinical trials and disclosure of data.

INVOLVE is the national advisory group for the promotion and advancement of public involvement in all forms of health and social care research. Established in 1996 we have been funded by the National Institute for Health Research (NIHR) since 2006 and remain one of the few publicly funded organisations for public involvement in research across the world.

The perspectives of patients and the public are crucial to any discussion on clinical trials. They are key as both participants in trials and ultimately as the people for whom the research is aimed to benefit.

Active public involvement in research and research governance is vital to ensure that the interests of patients and the public are considered alongside those of researchers and clinicians. For example they can bring a patient perspective on important issues such as consent, anonymity, risks, safety, transparency and the acceptability and relevance of research. Whilst the public as well as researchers recognise the importance of streamlining and reducing bureaucracy this needs to be done in a way that is acceptable to patients and for patient benefit.

INVOLVE’s primary focus is on improving and strengthening public involvement in the design and delivery of research. Nonetheless, over the last decade, we have built up considerable knowledge and expertise in the issues and concerns of patients and the public about the conduct and impact of research more generally. This includes the registration of clinical trials and reporting of trial results.

It has been a perennial complaint of clinical trial participants that they are very rarely told the results of trials they have taken part in and how it has benefited medical research into their condition. Where they take it upon themselves to track down results and any accompanying data they often find it impossible to do so. As patients and the public become more knowledgeable about their condition through the web and other sources, we believe it is imperative that ways are sought to improve transparency in this area so that patients, with their doctor, can make appropriate treatment decisions informed by the latest evidence available.

What evidence is there that pharmaceutical companies withhold clinical trial data and what impact does this have on public health?

At our recent INVOLVE Conference Sir Iain Chalmers presented evidence published in an article in the Lancet that research is underreported with for example over 50% of studies not publishing in full and over 50% of planned study outcomes not being reported. (Chalmers, I and Glasziou, P. (2009), Avoidable waste in the production and reporting of research evidence, 374: 86–89)

For the public to trust and have confidence in research and to improve patient care and treatment, there needs to be far greater openness and transparency in the publishing and accessibility of research findings. Researchers should be required to make all research findings publicly available as well as to feed back findings to participants. Patients who participate in clinical trials do so with the wish to improve treatments and outcomes for the future. If such research isn’t published then both their time and contribution as well as any learning for future research and treatment is wasted.

It is disappointing that, to the best of our knowledge, the pharmaceutical industry has taken no proactive steps in recent months to meet with and discuss the concerns of patients and patient groups on this subject. In our view this has only compounded the perception among many patients and the public that the industry is not acting in their best interests. We would welcome and hope that the Select Committee will encourage a more open dialogue among all relevant parties.

What is the role of the Health Research Authority in relation to clinical trials and how effective has it been to date?

The Health Research Authority and NRES have to balance protecting and promoting the interests of patients and the public alongside addressing unnecessary bureaucracy in research governance.

Since the establishment of the HRA in 2011 they have been proactive in their aim to create a unified approval process and to promote proportionate standards for compliance and inspection within a consistent national system of research governance. They have also recently announced plans to develop an HRA policy framework for transparent research, looking at registration, publication, dissemination, access to data, access to tissue and providing information on study results to participants.

Since 2006, INVOLVE has worked closely with NRES to support and develop the role and contribution of the public to ethical review and research governance. With the establishment of the HRA they have continued to work with ourselves and others to ensure that patient and public perspectives are integral to the way that they operate and are in the process of developing their strategy for public involvement. We also welcome the steps that HRA is taking to improve the evidence available on public attitudes to research regulation generally with its recently announced Sciencewise public engagement project.

How could the occurrence and results of clinical trials be made more open to scrutiny? Who should be responsible?

The NIHR is working to improve guidelines and policies to ensure that all NIHR funded research is reported fully and publicly available when the research has been completed. Similar guidance and self regulation is needed for the pharmaceutical industry and other funders. However, in addition there is a role for the Health Research Authority and MHRA working with patients and the public to regulate and monitor the reporting and publishing of research.

In view of the new statutory duties on all NHS organisations to advance and promote research (Health and Social Care Act 2012, and the Government’s welcome drive to increase research participation among patients, we would also support any steps to ensure that patients are told the results of trials they have taken part in and thanked for their role in making research happen. This sort of commitment can only help to encourage more patients to choose to take part in research.

Finally, the UK Clinical Trials Gateway (CTG)—one of the few patient-facing pledges in the Government’s Life Sciences Strategy—has the potential to be the central point for accessing and recording the progress of all clinical research, providing publicly available information on current research as well as the outcomes of the research in an accessible language and format.

A recent NIHR commissioned survey showed strong support for the idea of the Gateway among patients and the public. Nonetheless respondents identified a range of improvements and modifications to UKCTG with transparency a common theme. For example, in recent months INVOLVE has been leading work as part of an overall drive to include both plain English summaries of all studies as well as plain English summaries of the findings of research. This would help to raise public awareness of both the nature of research being undertaken as well as the extent of reporting of research findings.

February 2013

Prepared 16th September 2013