Clinical studies are important for medical development. Patients are usually, however, only involved in a passive manner. Whether new diagnostic or therapeutic methods are effective is measured on them. The patients have no influence on the creation of a study in this function. “However, this is problematic, as this poses the danger that the needs and interests of patients are not figured into the research,” according Professor Gerhardus from the Institute of Public Health and Nursing Research. That is why patients and researchers are increasingly demanding that patients are actively involved in clinical research processes. They offer - independently of the researchers’ knowledge – a unique view on the research topic thanks to their own experience and are in this way experts in their own right.
Investigating the “Right Issues”
The involvement of patients can, amongst other things, help to make sure that the “right” issues are being investigated – those that are important for day-to-day life and of which the results can be transferred to the practical field of treatment. Professor Gerhardus emphasizes; “a large amount is pumped annually into research. However, we need more research that produces results that are needed and can be used. Patients’ involvement could help us to do this.” The involvement can be realized in a variety of ways. For example, patients could take on an advisory role in group discussions or work together with researchers in the study team over the entirety of the study duration. Alongside finding the right research issues, involvement can also help in designing information materials and results in such a way that they are easily comprehensible for the affected and that they provide support during decision-making, for example when deciding between two treatment types.
Involvement in Germany
Whilst patient involvement in other countries, such as Great Britain or the USA, has been established for a long time now, the topic is relatively new in Germany. For several years, large research sponsors (BMBF and DFG) have been making involvement a criterion for the financing of studies. This means that researchers submitting a clinical research proposal for financing must explain in which form patients will help to shape the study. However, to date there has been a lack of orientation for researchers and evaluators regarding the definition of involvement and how it can be successful.
Guidelines Published
In terms of the results of the BMBF-funded project, the Institute of Public Health and Nursing Research at the University of Bremen and the Bremen Competence Center for Clinical Trials (KKSB) have now developed the first German-language guidelines. The guidelines use practical examples to show how involvement can be planned and implemented. “The guidelines fill a gap,” emphasizes Dr. Imke Schilling, who was involved in the creation of them. The health scientist completed her PhD on the topic. Based on discussions with clinical researchers, she knows that most of them have not yet had any experience with the involvement of patients and wish for support. “There is still a great deal of insecurity, as patient involvement is something very new.” Now, orientation is finally here.
Futher Information:
https://www.ipp.uni-bremen.de/patient-innenbeteiligung (in German only)
Contact:
Dr. Imke Schilling
Institute of Public Health and Nursing Research (IPP)
University of Bremen
Phone: +49 421 218-68805
Email: Imke.schilling@uni-bremen.de
