Position PaperPatients and health professionals working together to improve clinical research: Where are we going?☆
Introduction
The question: ‘Should advocates be involved in the design of clinical trials?’ was explored in a Europa Donna Workshop at the 5th European Breast Cancer Conference in March 2006. An advocate is an ‘intercessor or defender’, or ‘someone who pleads the cause of another’. I, as an Independent Advocate for Quality in Research and Healthcare, was asked to talk about patient involvement in research. I also defined myself as a patient; a patient–researcher; an observer, and a commentator on this rapidly developing phenomenon of ‘patient and public involvement in research’. A letter on bmj.com (March 2006) coined the terms ‘emancipated patient’ and ‘experienced patient’ in preference to ‘expert patient’.1
Words such as ‘advocate’ and ‘patient involvement’ should be used with precision.
Words in common usage are often used carelessly: semantic interoperability should be striven for.2, 3 Wright and colleagues in their paper in the current issue of Health Expectations are similarly at pains to achieve precision when they define ‘participatory research’4 when they describe development of this activity. They also confirm that methodologies and recruitment strategies can continue to evolve5 even in the course of work.
The rôle of involved patients was neatly defined by Roger Wilson, Chairman of the UK National Cancer Research Network Consumer Liaison Group. (NCRN CLG). He wrote:
‘Members are nominated because of their individual experience, not because of their connections, even if their connections were the route by which they were contacted. Members of the CLG are appointed as individuals.
There are very good reasons for this approach. First, the experience of cancer, whether as patient or carer, is very personal and it is that first hand experience that NCRN/NCRI needs to capture. Secondly, the role of many charities is advocacy, maybe not exclusively, but certainly part of their activity. The aim has always been that representation in the peer review process should be as an equal, not as an advocate (which, by definition, is external to the process).’6
Advocates can advocate externally FOR research (or other matters), but not from WITHIN research teams. A ‘new professionalism’ in relationships with doctors is being sought7: it has to be defined, learnt and cultivated.8
Section snippets
The establishment of the CAG-CT
Europa Donna Workshops provide a vehicle not only for health professionals and patients to learn from each other, but also to provide stimulus and ideas to newer member countries who may be glad to learn of the experiences of those who have been active for some years. With this in mind, it is hoped that this brief sketch of an early UK initiative might prove valuable and instructive.
The unique requirement for equality and individuality of input was emphasised at the first meeting of the
The work of the CAG-CT
The CAG-CT began work at its first meeting by commenting on the draft of a feasibility study examining the use of HRT in women with early stage breast cancer. This work shaped development of the multi-centre national trial of HRT in Women with Early Stage Breast Cancer. [ISRCTN 29941643],11, 12 (See INVOLVE website database, Project No. 44. www.invo.org.uk).
We successfully applied for funding from the NHS Research and Development Cancer Programme in 1995 against a call for proposals in their
Addressing general uncertainties
I want to emphasise that, in this project, the CAG-CT’s breast cancer patient–researchers undertook this work, not through personal, individual interest in the effect of use of HRT in conjunction with a diagnosis of breast cancer, but because they appreciated the general high level of uncertainty about this. They knew that clinicians, and huge numbers of breast cancer patients, many of them suffering from extreme menopausal symptoms as a result of the treatment itself, were confused and
Endorsement for and recognition of our activity
New joint approaches of working together in research endeavours require promotion, endorsement and evaluation if they are to be taken seriously. Endorsement of the CAG-CT initiative was given by the House of Commons Health Select Committee in their Report on Breast Cancer Services (HMSO July 1995): ‘We believe that patient involvement at all stages of a trial, including initial design, is essential, and that initiatives such as the Consumers’ Advisory Group for Clinical Trials are to be
Patient and public involvement in research today
In the UK, research activity involving patients has gathered momentum in the last 10 or 15 years to a point where major funders now require that research teams involve patient and the public in their projects as active participatory researchers.4, 21 Evidence suggests that benefit from their participation outweighs the drawbacks.22, 23, 24, 25, 26. Clinical research has become more sensitive, more relevant (to the patient), and of greater benefit to society and the NHS as a result.
Users are no
The future
Patients and clinicians must now work together to shape the therapeutic research agenda,4, 8, 16 and to develop and use new models of engagement. Together they must identify and order the priorities for research about topics that matter to patients, to lift them to the top of the agenda. The UK leads the way in promoting collaboration in the research process from pre-trial through to dissemination and implementation: many models are available on the database of INVOLVE.29
We can now extend this
Research governance
Research governance is necessary to protect patients, professionals and organisations, but its introduction and implementation in the UK has been a shambles.38, 39 Everyone must strive for regulatory processes that are sensible, fair, appropriate and adequate.
Adherence to the letter of the law, rather than its spirit, combined with lack of flexibility and common sense, has resulted in unethical and unacceptable delays for researchers in the UK,40 and loss of morale.41 A way forward to ensure
Conclusion
When the composition of any group of stakeholders changes, the power dynamics are altered. As an initiative develops over the course of time, it goes beyond the scope of originators to influence or shape – what Epstein describes as the ‘rebounding pathways of influence and engagement’. We have probed into the hitherto closed ‘black box of science’ in the search for reason and compassion when we test treatments.10 This is a ‘new approach to the study of the politics of knowledge-making’ – a
Conflict of interest statement
No conflict of interest.
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Today‘s patient: passive or involved?
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Involving consumers in designing, conducting, and interpreting randomised controlled trials: questionnaire survey
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Meaningful engagement of the patient in rare cancer research: sarcoma as an exemplar
2021, Current Problems in CancerCitation Excerpt :Sarcoma as a group of cancers is rare and presents an opportunity to illustrate the importance of including the patient perspective when planning research especially in rare cancers. In the late 1980s, it was noted that patients should be involved in the development of cancer research.1,2 The specific insights that are most valuable as well as how to best gain these insights continue to evolve over time.3-6
Randomised controlled trials of palliative care - a survey of the views of advanced cancer patients and their relatives
2008, European Journal of CancerCitation Excerpt :The necessity for consumer involvement in the design and conduct of controlled trials is well recognised. Such involvement is likely to improve the relevance to consumers of the questions addressed and the results obtained.31,32 If the results of this survey are used to guide future trial design, it might increase the likelihood of successfully completing RCTs and thus decrease the uncertainty surrounding many of the interventions used in palliative care.
Clinical trials - A brave new partnership: A new doctor-patient working relationship in research
2008, International Journal of SurgeryCitation Excerpt :He pushed the boundaries with his 1993 Lancet paper “new approach for recruitment to randomised trials”17: this was met with excitement in my editorial commentary, but also with robust challenge.18 It led on to organised, productive, brave new partnerships in research, not just in breast cancer,19 but also generally. [Ductal Carcinoma In Situ (DCIS)]
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2008, British Journal of AnaesthesiaBeyond scientific rigour: Funding cancer research of public value
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2009, Journal of Radiotherapy in Practice
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From a presentation given at the 5th European Breast Cancer Conference (EBCC) Nice, France, 21st–25th March 2006 in a Europa Donna Workshop 24th March 2006, entitled: ‘Should advocates be involved in the design of clinical trials?’ against the given title: ‘Patient involvement in research (including the work of the Consumers‘ Advisory Group for Clinical Trials (CAG-CT)’.