https://orcid.org/0000-0002-3146-273X
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).
Abbreviations
PG, patient group; SR, systematic review; BRT, broad reason types; NRT, narrow reason types.
Availability of Data and Material
A list of all publications included in the SR and a detailed list of all reason type occurrences in each publication are part of the additional material. Further data and material can be requested from the first author.
Author Contributions
All authors contributed to data analysis, drafting or revising the article, gave final approval of the version to be published, and agree to be accountable for all aspects of the work.
Funding
This work is part of the joint research project “PePPP” and is supported by the European Social Fund (ESF), reference: ESF/14-BM-A55-0050/16, ESF/14-BM-A55-0045/16 and ESF/14-BM-A55-0046/16, and the Ministry of Education, Science and Culture of Mecklenburg-Vorpommern, Germany. The funding bodies had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. We acknowledge support for the Article Processing Charge from the DFG (German Research Foundation, 393148499) and the Open Access Publication Fund of the University of Greifswald.
Disclosure
All authors report grants from the European Social Fund during the conduct of the study. The authors declare that they have no other competing interests in this work.