Science and Technology CommitteeWritten evidence submitted by the Royal College of Physicians

The RCP welcomes the opportunity to respond to the House of Commons Science and Technology Committee’s inquiry into clinical trials and disclosure of data.

The RCP is progressing its work in relation to this issue, and other ethical issues relating to the relationship between health professionals and the life sciences industry, as part of the Ethical Standards in Health and Life Sciences Group (http://www.eshlsg.org/). This is a cross-sector group, consisting of 20 organisations, that aims to evolve the relationship between healthcare professionals and commercial life science organisations to ensure that it meets the expectations of stakeholders and creates a platform for increased collaboration and partnership for the benefit of patients. The group is underpinned by the belief that the best way to improve this relationship is through collaboration and draws its membership from the health and medical community and the pharmaceutical, medical device and diagnostic industries in the UK.

We welcome the committee’s inquiry into this important issue and the opportunity to provide input. The RCP is committed to raising standards and clinical research is vital to improving patient care. We welcome the government’s commitments to place research at the heart of the NHS. Clinical research studies are a vital part of establishing whether a medicine or healthcare product is safe and effective. It is important that UK retains its world leading status in health research and remains an attractive place to carry out clinical trials. We welcome efforts to improve the EU legislation on clinical trials to ensure that genuine harmonisation is delivered across the EU, as outlined a recent joint statement, to which we were a co-signatory, with other supporters and funders of health research.1

We are supportive of the objective to see full disclosure of clinical trials results. In 2012, the ESHLSG published a statement on clinical trials transparency, “Clinical Trial Transparency Principles and Facts”.2 This document is currently under review; however it stresses our belief that investigators involved in clinical trials have an obligation to report the trial in a timely and non-biased manner. There is a moral responsibility to study participants and society to share results freely—and thus assist in the development of further research involving better trial design, fewer patients and to avoid unnecessary duplication.

There are a number of legal and voluntary accountabilities that currently exist to deliver clinical trials transparency. Unfortunately, not all of these measures are as effective as they should be and the evidence demonstrates that the results of many clinical trials are not published in a timely manner. Greater adherence to these procedures, accompanied by monitoring to assess compliance and appropriate sanctions to drive positive behaviours, could play an important role in progressing towards greater clinical trials transparency. The committee will need to consider how this can be achieved and whether further measures are also needed.

Serious consideration needs to be given to how we can achieve and enforce effective clinical trials transparency. Indeed, this is a topic of current discussion for the ESHLSG. Implementing a system of full disclosure will have implications, for example in terms of cost, time commitment and feasibility. This should not, of course, deter efforts to deliver transparency, but will require development of realistic goals in terms of what should be published, when and how. In addition, the legal and voluntary accountabilities currently in place do not address the important issue of retrospective data publication, which is key to enabling decision-makers to draw conclusions based on all the evidence and consequently to make decisions that are in the best interests of patients. Serious consideration is therefore also required as to how retrospective publication should be delivered.

The potentially forceful influence of health professionals should also not be underestimated. Those who take part in trials are in a position to hold the companies to account and to ensure they are delivering on transparency. We see such principles as key to the collaborative approach of the ESHLSG.

The ESHLSG’s work to evolve the relationship between healthcare professionals and industry will only succeed if it is built on transparency. The ESHLSG is currently also working to address such transparency in additional of areas, including:

The disclosure of financial relationships that exist between the life sciences industry and health professionals. We are currently carrying out a consultation on this topic.3

Pharmaceutical support for medical education. We recently undertook an online survey seeking views on this topic from healthcare professionals, to inform our work.

February 2013

1 http://www.rcplondon.ac.uk/sites/default/files/documents/2012_joint_statement.pdf

2 For more: http://www.eshlsg.org/our-work/#clinical-trials

3 For more: http://www.eshlsg.org/our-work/#payments-to-health-care-professionals

Prepared 16th September 2013