Involving patients in clinical research

Traditionally, patients have been involved in research as “subjects,” or even “objects,” but definitely not as colleagues. In 1995 the BMJ argued that “patients should help to decide which research is conducted, help to plan the research and interpret the data, and hear the results before anybody else.”¹ How far have we come in the past four years in realising these hopes?

We need to recognise that patients (participants, users, consumers, what you will)²,³ have the experience and skills that complement those of researchers. They know what it feels like to suffer a particular disease and to undergo the treatments with their various side effects. They will have a good idea of which research questions are worth asking, and when a question should be framed differently.⁴ For instance, researchers at Mount Vernon Hospital hypothesised that moving follow up breast cancer clinics to primary care might relieve the burden on hospital outpatient clinics. After consulting women with experience of the problem, however, the protocol was redesigned to address the issue of easier access to specialists.⁵

Some progress has certainly been made in the United Kingdom in the past few years. Several conferences and projects have explored the possibilities for involving consumers in NHS research.⁶ This makes sense for both the health service and the pharmaceutical industry⁷—for if outcome measures are not relevant to patients why should they bother to take part in clinical trials?

So how does the partnership work in practice? The international Cochrane Collaboration has made a great effort to involve consumers from the beginning. The NHS Health Technology Assessment Programme too has made strides in involving consumers in its work.⁸ However, practical problems abound. Funding for consumer attendance at conferences is now easier to obtain, but so far there is none for the sometimes onerous task of assessing protocols. For academics this is regarded as all in the day’s work, but consumers have to take time off from other commitments and perhaps learn new skills before feeling competent to comment. In Australia consumers are attending training courses on science and advocacy to help them develop the necessary skills and are seeking funding to attend the project LEAD (leadership, education, and advocacy development) course in the United States, which is now seen as a prerequisite for women participating in breast cancer research activities funded by the US Department of Defense and the National Cancer Institute.

There are also major cultural differences still to be overcome. Yet with some imagination these differences can be dealt with. In this issue, for example, Macaulay et al review participatory research with communities and illustrate successful research partnerships with communities as diverse as a Mohawk community in Canada and a township community in South Africa.⁹ In the United States the Department of Defense funds about $150m worth of breast cancer research annually. This appropriation was initiated by consumers as a means of increasing breast cancer research while not affecting levels of research in other health areas. The US army already had a breast cancer research programme because of the impact of the disease on women in the army. Since congressional funding programmes are ring fenced, it was necessary to build on an already existing programme rather than divert funds from one area to another. In return consumers have made a major, although initially controversial, impact on the research process. In the first year the inclusion of consumers on both peer review and programme review panels was questioned, so an evaluation was undertaken. Preliminary findings from the quantitative data indicate an increase in scientists’ positive views of consumer reviewers and an increase in positive views among consumers, who felt that the concerns of patients were extremely influential in the review process.¹⁰ This model has now been incorporated into other American research organisations such as the National Cancer Institute.

In Australia consumers are being included on the management committees and scientific advisory committees of large research groups such as the Victorian breast cancer research consortium and are being consulted on specific issues such as informed consent by groups organising clinical trials in breast cancer. This latter involvement led to many suggestions by consumers for new research questions—such as, what is the prevalence of lymphoedema after surgery for breast cancer? For such activities to be successful, consumers must be well organised, skilled in advocacy, thoughtful about their approach and accountable to, and representative of, a range of people.

At a recent workshop in the United Kingdom, it was recommended that researchers requesting funding should show evidence that they have consulted consumers in drafting their proposals and should budget for the expenses of doing so. It was even recommended that there should be a majority of consumers on research committees: “Instead of being asked about their research priorities, they would be asked about what problems they see or experience, and supported to translate these into research questions.”¹¹ Other recommendations included acknowledging the importance of qualitative research methods for exploring many of the issues that matter to patients and providing lay summaries of research protocols and research findings.

The implications for medical journals are clear. Besides insisting on informed consent from trial participants,¹²,¹³ they should set new standards for consumer consultation at all stages of clinical research submitted for publication. Wherever possible, consumer peer review should be sought. Where there has been no consumer input into the original design (and obviously it will take some time for this recommendation to be implemented), journals should seek consumers’ commentaries on published papers. These are tough requirements, but they are likely to ensure greater rigour and relevance for future research.

Education and debate p 774