Participant recruitment can be a significant hurdle in clinical trials. With reduced patient foot traffic at hospitals, the challenge in recruitment will continue to grow in the current context. Currently, participants are typically recruited for trials by treating physicians, and/or clinical research associates as a part of the participant’s circle of care. eRecruitment can be a useful tool in recruiting study participants and can be categorized into two broad strategies, participant-driven and institution-driven. Participant driven eRecruitment involves the participant actively searching for resources and opportunities to participate in a clinical trial as part of their care. Institution driven eRecruitment involves “permission to contact” programs and identifying potential participants through database searches of EMRs. This strategy is often supported by new technologies, such as blockchain and artificial intelligence, that can improve how we identify and recruit participants in trials.
However, in many institutions patients are not automatically “opted-in” to be approached for research as a part of normal care. Further, many hospitals do not have the infrastructure to run artificial intelligence solutions and must vet privacy and security risks of such solutions. Acquisition and implementation costs for tools/systems to support EMR search tools and reporting. Organizational policies around use of social and electronic media for recruitment purposes are not well established.
Participant driven approaches must implement proper processes to support privacy during recruitment activities. Further, there may be a necessity of screening eligibility of potential participants after self-selection (e.g., when social media used for recruitment purposes).
- Strategies and Opportunities
Ethics and Regulatory:
- REB approval requirements must be met for in-house participant identification through EMR records (Permission to Contact programs).
- REB approval is required for external internet-based screening or participant recruitment processes.
Privacy and IT :
- IT infrastructure to support in-house participant identification through EMR data (Permission to Contact Programs) and/or external social media recruitment processes.
- Specific legal considerations exist for Permission to Contact Programs using an opt-out option.
- 3rd party platforms should be approved by the institution’s privacy and IT officers.
- Site IT infrastructure to support participant identification through EMR data, or social media recruitment strategies will be impacted.
- Organizational policy related to in-house participant identification through EMR records, privacy compliance, legal and liability issues must be considered and followed.
- Social media tools should align with established electronic search tools (clinicaltrials.gov).
Patient / Caregiver:
- Limitations in access to technology may contribute to equity issues. Hybrid approaches to recruitment that involve care providers may better support equity.
- eRecruitment may improve awareness and access to research opportunities that are currently limited by care providers awareness and access.
- Some hospitals have adopted opt-out permission to contact programs.
- Covidtrials.ca: Covidtrials.ca is a portal to match voluntary participants with a clinical trial. Prospective volunteers can visit the website and fill out an online registration form with their information. That data is then shared securely with the appropriate research teams, who can then contact the person directly if their profile matches the needs of the trial. Covidtrials.ca is a not-for-profit initiative of company called Think Research.
- Canadian Blood Services – COVID-19 convalescent plasma donor registry: Canadian Blood Services is part of Health Canada approved clinical trials to test the safety and effectiveness of COVID-19 convalescent plasma as a possible treatment to help patients with the virus. They have created an online registry where anyone who is interested in participating in the Health Canada approved clinical trials can sign up as a potential convalescent plasma donor. Registrants will be contacted if they are eligible.
- 3CTN Clinical Trials Navigator
Opportunity to improve access to/uptake of decentralized approaches:
- Explore patient registry approach to recruitment: e.g., therapeutic area specific approach (look at COVID registries and QC COVID registry, 3CTN example) such as life-threatening or rare disease.