How practice based research networks facilitate clinical drug trials in German general practice

Problem

German medical regulations lead to clinical drug trials, being the most resource-intensive research projects in primary care. The conduct of those trials is challenging and can test the commitment of general practitioners (GP) and their teams as well as patient care. Since 2020, practice-based research networks (PBRNs) have been established in Germany at a national and regional level to provide a high standard of support for collaboration between researchers and practice teams when conducting clinical (drug) trials.

Approach

The aim is to demonstrate how the implementation of PBRNs helps to facilitate the conduct of clinical drug trials in German general practice and how the research infrastructure is used to support those involved using three examples

Findings

Since 2020, three large-scale investigator-initiated randomized controlled trial (RCT) have been initiated within the PBRN networks. One RCT investigates prednisolone versus colchicine in patients with acute gout (COPAGO). It is a multicenter, pragmatic double blind RCT with a parallel group design that includes 314 patients. Another trial investigates safety and effectiveness of prednisolone and vitamin B1, B6, and B12 in patients with post-COVID-19-syndrome. PreVitaCoV is a multicenter, double-blind, placebo-controlled trial with a factorial design in which four parallel treatment groups with prednisolone and/or vitamins B1, B6 and B12 are tested. The sample size comprises 340 patients. The third drug trial is a participation in the Primary Care Adaptive Platform Trial for Pandemics and Epidemics, an international project (ECRAID Prime) involving 999 primary care patients with respiratory infections from six European countries. The aim of the RCTs is to find new therapies for patients with respiratory tract infections. The PBRNs provide regular training to qualify the practice teams in clinical trials and incentivises participation in both training and clinical trials. The infrastructure also facilitates the recruitment of GP practices to participate in clinical drug trial. The practices are involved in the conduct of RCTs to varying degrees depending on study design and study-related workload. Several tasks are performed by the infrastructure e.g. by supporting practices on site via flying study team.

Consequences

Experience gained in these studies will be evaluated to determine which support was most successful in implementing clinical drug trials in German general practice. Implications for other countries such as the UK will be discussed.