Community-First Approach to Sickle Cell Disease Clinical Research

The ASH Research Collaborative’s approach to sickle cell disease clinical research builds trust by shaping research priorities, clinical trial processes, and protocols based on input from the community of those directly impacted by hematologic conditions, for whom the trials are conducted. Trust is critical in recruiting participants into research and education programs. Engaging the community at the design stage builds that trust and demonstrates fidelity to participants’ interests, helping ensure that the ultimate research results are credible to the community that the research is intended to benefit, while education ensures that participants are empowered to make informed decisions about their treatment and participation in the trials. How does this build trustworthiness? This engagement strategy emphasizes relationship-building that facilitates listening to and acting on community needs.

How It Works

The ASH Research Collaborative’s (ASH RC) shared vision for community engagement includes potential participants, their caregivers, and SCD-related community and faith-based organizations. Community advisory boards and volunteer working groups are locally based, near the clinical research sites, and are the foundation of our network. Involving the community early and in a meaningful way allows us to foster a culture of collaborative engagement and research, co-create educational materials with the community, implement community-first approaches to research, and empower the SCD community to make informed decisions about their care.

ASH RC’s shared vision for community engagement will address many of the common barriers faced in clinical trials research by helping the community to overcome barriers to participation, involving the SCD community in research design, and education on informed decision-making.

The Community Advisory Boards (CABs) are foundational to the success of this network. The goal is for our CABs to provide a safe and supportive platform for community members to assemble and discuss matters regarding the priorities of the local and national community and provide input on clinical trials processes and protocols.

Our CAB model consists of the local CAB, where members of the community who are central to the clinical trials sites are located. Two representatives from each local CAB will be elected to participate in the ASH RC’s National CAB. This approach helps to make sure that there is a bi-directional flow of information from the local to national level.

Members of the National CAB will also serve on our Initial Protocol Working Group, where all protocols brought to the Network will be evaluated before filtering down to the local CAB community.

Skills and Competencies

Our comprehensive community engagement program involves:

  • Hosting a series of community-based workshops, designed to understand the experiences of the community;
  • Leveraging our community advisory boards and volunteer working groups to assist us in creating community-first research by providing their input on clinical trials processes and protocols;
  • Raising awareness and educating the community by conducting needs assessments and landscape analysis; and providing fun and engaging national digital and social media campaigns;
  • Connecting the community to resources and platforms to access customized education and outreach materials for participants, caregivers and providers; and
  • Utilizing best practices for participant engagement to improve research experiences.

Origins

To address local SCD community clinical research needs, we started with asking questions such as:

  • What is the “best way” to engage the SCD Community at the local level?
  • How do SCD community members who do not have access to an Academic Medical Center participate in clinical trials?
  • How do we shape the future of SCD research to ensure that what is important to the community is relayed to help researchers design community-first clinical trials?
  • Do you feel that a cure for SCD should be the number one priority for researchers?
  • Outside of a cure, what SCD symptom would your ideal medication address?

We are at a crossroads with SCD research. Although there is a rich therapeutic pipeline for SCD research, many programs continue to face participant enrollment and retention issues.

The answer to these questions is found in our comprehensive approach to community engagement.

Effectiveness

ASH RC’s approach to community engagement has been successfully implemented in other disease states such as HIV/AIDS and Cystic Fibrosis. The HIV/AIDS community was very instrumental in the development of “patient-centric” research, constructing CABs to provide meaningful insight to research teams and building trust among those living with the disease and the broader research community.

The nearly 500 participants in our 2019 SCD community engagement workshop series contributed to a report featuring the valuable insights provided on clinical research. This report will be used to communicate the needs and preferences of the broader SCD community. The paper was submitted for peer review and will be published soon.

Each sponsor submitting research protocols for review to become a part of the network will be given the report to review, furthering our commitment to create a community-first clinical research network.

The report will be a living document, owned by the SCD community. The workshop series was the first step in initiating the constant discussion of the SCD community’s research priorities. As we receive feedback from the CAB community, we will update these priorities, ensuring that our community engagement plan is in alignment
with the current needs of the SCD community.

Scalability

To ensure the best reach to the broader SCD patient community, we have adopted our community engagement model with scalability in mind.

The structure of the CTN uses the hub and spoke model with the Clinical Trial Unit (CTU) serving as the clinical research hub containing multiple Clinical Research Sites (CRS). Each participating CTU will have a designated Principal Investigator, CTU Coordinator and a local community advisory board (CAB). This model is being utilized across the country, where SCD research sites are participating in the ASH RC SCD Clinical Trials Network.