Who better to talk about the communication needs of research participants than people involved at all levels of clinical research? We have reviewed existing literature, gathered Australian perspectives, and engaged in workshops and pilot projects to develop resources that reflect the changing landscape and expectations of research participants.
White Paper
The team started by commissioning a rapid literature review of published evaluations of two-way communication in clinical research and relevant Australian policy and guidance documents. This review found that the effectiveness and impact of embedding effective communication is often not evaluated, with only 17 papers identified that met the criteria.
Evaluations of Communications (review)
The findings of the review confirmed an unmet need and were used as a starting point for interviews with research staff, developing materials for the participant workshops, and developing the scope for the pilot project.
Gathering Australian perspectives
The team interviewed 20 people working in Australian clinical research projects, including those in participant facing roles, site managers, sponsor representatives, and researchers. The purpose was to understand current communication strategies used in both observational and interventional clinical research projects. We asked about the benefits and challenges faced when embedding these strategies into their past projects, and how they would ideally embed communication into future projects.
The findings from the research staff interviews were also used to inform workshops with Australian clinical research participants about their experiences communicating with their clinical research team. Three workshops were conducted with 22 past participants, both online and in-person. They were asked about their specific experiences and what they would ideally like in future projects. This was framed both as general principles and related to specific communication strategies identified in the white paper or the staff interviews. The workshops were supported by a trained moderator from the Hunter Medical Research Institute.
Pilot project
Through developing the white paper, we were aware that there had been little work done on evaluating strategies to facilitate communication between clinical research teams and their participants. We were also aware that site staff work within the parameters of the protocol, their staff availability, site budgets and their site protocols (such as ethical and governance reviews). To investigate this further, the VCCC Alliance partnered with WEHI to develop a pilot project to evaluate participant communication preferences within a clinical trial.
The pilot project is a sub-study of an investigator-initiated project (FORECAST-II) testing a new way of determining which cancer treatment is most likely to be effective for each participant. The sub-study will ask participants about their communication preferences, track the resources required to deliver those preferences at both the site level and the sponsor, and measure the perceived benefit of these communications for participants.
Beyond the Form case study: Tracking preferences to deliver study updates