Background: The connection between participants and their research team can affect how safe, informed, and respected a participant feels, and their willingness to complete a research project. Communication between researchers and participants is key to developing this connection, but there is little published work evaluating how communication during clinical research is conducted.
Purpose: This paper explores what communications happen (and how) with research participants in Australia post consenting to participate in clinical research. It provides reflections from Australians working in clinical research about their current strategies, or those they would like to use, to communicate with research participants.
Methods: This exploratory, qualitative descriptive study reports findings associated with twenty semi-structured interviews that were undertaken with people who work in clinical research in Australia (such as staff in participant facing, site management, or sponsor representative roles). These interviews were conducted and analysed inductively using thematic analysis.
Findings: Research staff reported using a range of communication strategies which varied in implementation, uptake, and suitability between clinical research studies and sites. Four major themes were identified in the interviews: [1] staff use innovative pragmatism to communicate; [2] staff tailor the communication strategies to fit the participants' context; [3] the site, its systems, and staff training all impact communication; [4] successful communication requires collaboration between stakeholders.
Conclusion: There are a variety of communication strategies, methods and activities research staff currently employ with trial participants, which vary in purpose, method, resources required, and suitability between studies and sites. Thorough consideration of the participants' contexts and the capacity of research sites is crucial for the design of studies which allow for effective communication between the research team and participants. The authors encourage those developing clinical research projects to involve site staff and consumer representatives early in planning for communication with participants.
The connection between someone taking part in a clinical research project and their research team is important, and can change how safe, supported, and informed the person may feel throughout their experience. The Beyond the Form project was established to explore ongoing communication strategies in Australian clinical research: specifically, how research teams are currently communicating with their participants, and how they could improve communication. This paper reports on the findings from interviews with clinical research staff. We found a wide range of strategies are used to communicate, with differences linked to the type of research being done, the research location, and the target population taking part in the research. It was identified that it is important to consider the likely nature and needs of participants in a specific research project to make sure the communication is appropriate. Being flexible about how the research staff can communicate (e.g. via text, phone, email, mail etc.), and what they communicate (e.g. in more or less detail about the project), was also identified by research staff as important to research participants. The findings from these interviews, as well as other planned project activities will inform development of a toolkit to help researchers incorporate effective communication into protocol design, and recommendations for site staff and ethical review bodies to help facilitate these strategies.
Keywords: Clinical research; Clinical trials; Communication strategies; Research participants; Research staff.
© 2024. The Author(s).