Primary care involvement in clinical research – prerequisites, motivators, and barriers: results from a study series

Abstract

Background: Long-term reinforcement in the role of primary care and improvement the healthcare system as a whole requires the involvement of GPs in clinical research processes. However, many clinical studies fail due to failure to achieve sample population targets amongst GPs and their patients. This issue has been identified and discussed, but effective strategies to overcome it are still lacking. One of the reasons is that the positions, requirements, and experiences of GPs on participating in clinical research have hardly been examined up to now. Methods: The years 2021 and 2022 saw three quantitative and qualitative surveys amongst GPs in Germany with the aim of shedding light on the attitudes, experiences, and potential issues regarding the involvement of primary care in clinical research projects and participation in cluster-randomised controlled trials (cRCTs) in a general sense. This overview summarises and abstracts conclusions gained from the exploratory series of studies and compares the results with the current research situation. From here, this contribution will then develop an approach towards optimising the integration of GPs into clinical research. Results: Most of the GPs asked associated clinical research with opportunities and potential such as closing gaps in healthcare, using evidence-based instruments, optimising diagnostic and therapeutic management, and reinforcement of multiprofessional healthcare. Even so, many GPs unsure as to how far primary care in particular would stand to benefit from studies of this type in the long term. Respondents were also divided on willingness to participate in clinical research. GPs having already participated in Innovation Fund projects generally saw a benefit regarding intervention and cost–benefit relationship. However, some also reported major hurdles and stress factors such as excessive documentation and enrolment requirements, greater interference in practice routines, and sometimes poor integration into project processes such as in communication and opportunities to play an active role in the project. Conclusions: Results from the studies presented provide indications as to how GPs perceive clinical research projects and cRCTs as a whole and from their existing project experience, and on the requirements that studies would have to meet for GPs to be willing to participate. In particular, making sure that clinical studies fully conform with GPs would play a major role; this especially applies to freedom to make medical decisions, limitation of documentation obligations, interference in regular practice routine, greater involvement in research planning, and long-term reinforcement in the role of primary care. Clinical research projects and cRCTs should be planned, designed, and communicated for clear and visible relevance to everyday primary care.