DEBATE: Patients should be part of clinical development. Regulations and a framework for user involvement in Denmark is a necessity
User involvement in clinical research is still an immature field in Denmark. This was the general impression after a seminar on this subject, which aimed to make a status on the development in this field and inspire for next step.
The debates at the seminar indicated that a framework, building capacity and administration from neutral authorities is necessary to strengthen a more systematic involvement of users in medical research. The systematic intervention is especially relevant in the Danish community, where we focus intensively on medical research and development both in public and private research.
The central message from the conference is that neutral actors should be involved to secure impartial support of a more systematic involvement of patients – user involvement in clinical research.
Why user involvement?
The aim of involving patients and users in medical research is to create a larger agreement between the treatments and the developed medicines and the experience, needs and demands of the patients.
Involvement of patients may contribute to a more experience based understanding of disease related problems, therapeutics and adverse reactions. This may also put focus on unmet medical needs as well as implementation new research based insights in clinical practice. This way user involvement may contribute to secure better solutions in the public health care system. Several of the attendants of the seminar furthermore pointed out that user involvement is an inevitable democratic imperative.
No matter from which starting point you look at user involvement, Jens Heisterberg, former Danish representative in the European medicines agency’s supreme committee for human drugs [CHMP], describes how even the presence of patients in the meeting room may influence. When patients participate in this powerful committee, the tone and spirit will change. This replaces an esoteric working jargon by a stronger receptiveness to what might be at stake for the patients.
International inspiration for a new framework
At the seminar Zoe Gray, director of the British institute INVoLVE, spoke. InVoLVE has facilitated user involvement in British health care research for 21 years. Zoe Gray stressed that it is necessary with clear guidelines and methodology to involve users at all levels in research. In a Danish context, there is not yet a common public framework for regulation and securing of patient involvement. Instead, we have the following challenges:
The Danish medical industry is among the actors who most actively involve users in development of medicine and treatments. This may create a question regarding the competence to act, when financial support from the medical industry means that patient organizations, sponsored by the medical industry, might be exposed as being in the pocket of the industry. Arguments were that the question of competence to act should be the same for patients and patient organisations ad for health care professionals who collaborate with the medical industry in various ways. A publicly facilitated framework for the collaboration between patients, patient organisations and medical industry would be helpful in developing the potential of user involvement, without risking that users would appear as ‘used’.
In practice, user involvement means a displacement of traditional roles it demands that both professionals and patients gain new competences that develop during the process.
At research units in Denmark, there are already initiatives, but there is no forum to collect and share experience.
Last but not lease, the missing public framework has resulted in a lack of clarity, when we discuss involvement. There is a huge difference between being a test person in a clinical trial, be involved in the prioritisation of research funding, take part in the approval of new drugs and treatments and be a partner in co-creation processes with the medical industry. Without clarity and a consensus, it is difficult to develop practice further, because we believe we talk about the same issue when we talk about user involvement.
The development is already happening
At the conference, the general agreement was that user involvement in medical research is an area, which demands a framework. As it happens now, there is a risk that an innovative and skilled medical industry, which mainly understands user involvement as a business model, will absorb the field. This is not always undesirable, but the debates at the conference point towards administration, capacity building and framework by impartial authorities as a necessity and that it is time to make this step.
The seminar was hosted by KORA, and was arranged in a collaboration between the three innovation networks BRANDBASE, Biopeople and lnfinlT and the GTS Institute Bioneer under the grant 'Biomarkers as emerging growth area in Denmark’ on 2. March 2017. The conference gathered researchers, patient organisations, and Danish and European expert in public authorities work as well as representatives from the medical industry. See www.biomarker.dk, www.brandbase.dk, www.biopeople.eu. www.kora.dk.