Project Title: Establishment of an objective evidence on the importance of clinical trial engagement on the recruitment and retention of participants in clinical trials.
Project Description: Community engagement is regarded as an essential component in clinical trials. It is a complex, dynamic, and interactive relationship between researchers, policy-makers, and the community. Many funding agencies require investigators to have an effective community engagement plan in their proposals, and it is regarded as an ethical requirement of most ethics committees before the trial protocols can be approved. However, there is a scarcity of studies that have objectively assessed the impact of these practices... Community engagement is regarded as an essential component in clinical trials. It is a complex, dynamic, and interactive relationship between researchers, policy-makers, and the community. Many funding agencies require investigators to have an effective community engagement plan in their proposals, and it is regarded as an ethical requirement of most ethics committees before the trial protocols can be approved. However, there is a scarcity of studies that have objectively assessed the impact of these practices on trial-related (such as rates of recruitment and retention) and community-related (such as community trust and support or sense of community ownership) endpoints, taking into account different types and phases of trials and underlying socioeconomic, cultural and local administrative contexts. Such evidence is necessary in order to inform researchers, funders, and local authorities about how best to engage the community in clinical trials and to help inform the development of best community engagement practices. In addition, developing a comprehensive set of community engagement goals and indicators of their successful implementation would assist investigators, ethics, regulatory authorities, and sponsors determine the minimal community engagement practices required to ensure the successful implementation of clinical trials. Using an in-depth review of the literature and focus group discussions with relevant stakeholders, we will develop a clinical trial community engagement conceptual framework and establish the best community engagement practices (benchmark community engagement plan). We will also develop an implementation assessment tool to assess the degree of implementation of the best community engagement practices of individual clinical trials. Finally, we will conduct a randomized controlled study where participating trials will be randomized to implement either our benchmark community engagement plan (intervention) or their pre-planned community engagement (control). To facilitate this activity, we will work very closely with principal investigators during the development of the protocols to include the benchmark community engagement plan in their protocols and supervise its implementation to ensure maximum compliance. Using our implementation assessment tool, we will score each trial on a number of activities and outcomes that constitute the benchmark best practices. We will assess the effectiveness of the benchmark plan using recruitment and retention rates as an outcome of interest, determine enhancers and inhibitors of successful implementation of community engagement, and establish a minimum list of essential engagement practices for successful implementation of clinical trials.
Principal Investigator : Ally Olotu
Department Name :
Time frame: (2021-02-28) - (2025-02-28)
Wellcome Trust (Normal)
External Collaborating Partners
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