<p>Involving Patient Groups in Drug Research: A Systematic Review of Reasons</p>

Abstract

Background: Patients have evolved from mere objects of study to active contributors to drug research in recent decades. Since individual patient's influence to change research processes effectively is limited, patient groups play an important role in the planning and conducting of pharmaceutical studies. Patient group engagement in drug research is usually seen as being beneficial from an ethical viewpoint as well as from the perspective of research practice, while potential disadvantages and risks have been discussed considerably less. Purpose: A systematic review of reasons was conducted to allow for an overview of the reasons for and against involving patient groups in drug research. Methods: The literature search was conducted in PubMed and Web of Science. Reasons concerning the influence of patient groups on drug research were extracted and synthesized using qualitative content analysis. The review's main limitation arises from a lack of critical appraisal regarding the quality of the reasons. Results: A total of 2271 references were retrieved, of which 97 were included in the analysis. Data extraction revealed 91 (73.4%) reasons for and 30 (24.2%) reasons against involving patient organizations in drug research, and 3 (2.4%) ambivalent reasons; amounting to 124 reasons. The main groups of reasons were clustered around the categories: quality of research, acquisition and allocation of resources, and the patient role in research. Conclusion: This is the first systematic review of reasons concerning the influence of patient groups on drug research. It provides a basis for a continuing debate about the value as well as the limits of involving patient groups. Due to the diversity of research projects there can be no general recommendation for or against patient group involvement. More research is necessary to assess potential advantages and disadvantages of patient groups' influence on other types of research (eg genetics).

Preventive pharmacological treatment in subjects at risk for fatal familial insomnia: science and public engagement

“…The engagement of patients as partners in healthcare research has gained consensus over the last two decades [ 51 , 52 ]. A number of reasons support the inclusion of patients as active partners in biomedical research and encourage funding to promote this participation.…”

Collective forward-looking responsibility of patient advocacy organizations: conceptual and ethical analysis

“…Such ethical issues arising within a PAO are accompanied by ethical questions occurring between different PAOs and other stakeholders. The involvement in politics [ 6 ] and research [ 4 , 5 ] and the cooperation between PAOs and economic stakeholders [ 7 , 8 , 20 ] can sometimes be problematic. Building financial relationships with industrial companies, for example, can help PAOs to pursue their goals [ 21 ] but might lead to pressure to conform to the funder’s interests [ 20 , 22 ].…”

“…Many organizations have committed themselves to support research. However, PAOs that want to foster biomedical research face many ethical questions, such as the extent to which they should encourage their members to participate in a study or the extent to which the specific interests of the PAO should influence the research designs [ 4 ]. Another problem for PAOs can be that external cooperation, for example, with politicians, might be characterized by tokenism [ 9 ].…”

“…The PAOs can play an important role in the planning and conducting of biomedical research. Many organizations have added contribution to research on their agenda and patients participation, for example, in the design of a research project is usually considered as ethically important in the current bioethical literature [ 4 ]. However, PAOs that want to conduce to research find themselves in difficult decision-making situations and are confronted with questions of responsibility.…”

“…Moreover, their activities are subject to ethical evaluations and linked with ethical concepts, such as responsibility. The involvement of PAOs in biomedical research [ 1 , 2 , 4 , 5 ], politics [ 6 ] and industry [ 7 , 8 ], for example, is seen as controversial and raises questions about the general character of their responsibility. Since PAOs are confronted with normative questions of responsibility in these exemplary fields of activity, they are expected to respond.…”