Involving Patient Groups in Drug Research: A Systematic Review of Reasons

Christoph Rach,1 Jan Lukas,2 Regina Müller,1 Matthias Sendler,3 Peter Simon,3 Sabine Salloch1 1Institute of Ethics and History of Medicine, University Medicine Greifswald, Greifswald, Germany; 2Translational Neurodegeneration Section (Albrecht-Kossel), Department of Neurology, University Medical Center Rostock, Rostock, Germany; 3Department of Medicine A, University Medicine Greifswald, Greifswald, GermanyCorrespondence: Christoph RachInstitute of Ethics and History of Medicine, University Medicine Greifswald, Ellernholzstr. 1-2, 17487 Greifswald, GermanyTel +49 3834 865780Fax +49 3834 865782Email christoph.rach@posteo.deBackground: 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).Keywords: patient organization, drug research, patient and public involvement, systematic review of reasons, bioethics