Recruiting Clinical Trial Participants

A recent report suggested up to 80% of clinical trials struggle with participant recruitment, and around 30% of participants drop out of a trial after they commence.¹ Australia has a relatively low per capita trial participation rate compared with other countries, with estimates of around 0.4% in Australia compared with 1.5% in the United Kingdom and around 2% in the United States.²

Recruitment difficulties increase trial costs, drain resources, and delay the implementation of evidence-based outcomes into policy and practice. The factors contributing to these challenges are complex and involve multiple stakeholders, including investigators, patients and families, hospitals, administrative staff, sponsors, contract research organisations and clinical trial research teams.

1. Know your target population: Identify key participant demographics such as age, gender, health condition, and location.

• With the appropriate approvals you could use medical records and/or health registries to identify eligible participants attending local hospitals or clinics. The Centre for Health Record Linkage (CHeReL) can provide access to linked health data for people across NSW and the ACT, while the Australian Institute of Health and Welfare (AIHW) collects national data.
• Review medical records and attend clinics to learn more about target participant groups.
• Engage with and educate external referrers.

2. Partner with consumers: Involving patient or consumer representatives in the early (design) stages of your research can help shape your participant recruitment strategy and identify more effective ways to target, approach and invite potential participants. Consumers can:

• Join as members of trial advisory panels or as research partners.
• Assist with protocol design and recruitment planning.
• Help draft and review Participant Information Sheets and Consent Forms (PICFs).
• Suggest different places and ways to approach potential participants.

3. Develop a marketing plan: Tailor your outreach to match your target population and their communication preferences. Understand where they are likely to seek clinical trial information.

• Create a promotion toolkit (flyers, inclusion/exclusion pocket cards, participant brochures).
• Promote the trial to your colleagues, medical or allied health professionals.
• Share trial information on hospital notice boards/clinics.
• Advertise on websites.
• Use social media groups.
• Leverage clinical trial apps that help people find your trial.

4. Pre-screen and screen effectively: If resources permit, use a dedicated recruitment team at your site or facility, to screen participants via email or direct contact from research staff.

• Prepare a thorough screening sheet based on the trial protocol inclusion and exclusion criteria.
• Where appropriate, ensure health or medical expertise is available to allow staff to seek answers prior to booking a screening visit.
• Consider cultural background and language when planning your discussions with potential participants.
• Develop and implement an action plan to reduce participant screen failures.
• Analyse screen failures and site recruitment rates to identify areas for improvement.
• Share the enrolment processes and success of high enrolling trial sites.

5. Fast-track screened participants: Book an appointment at the site and send a confirmation email to the participants with the relevant information including:

• Date and time for appointment.
• Map/directions to the study site and parking or travel instructions.
• Pre-visit instructions.
• Trial information – some sites send the Information and Consent form to allow the participants to review prior to their appointment.
• Confirm their attendance prior to their visit.

6. Track referrals, bookings and recruitment targets: Implement an appropriate tracking system that protects participants’ confidentiality and privacy.

• Monitor referrals, screened participants and booked study visits.
• Regularly review recruitment rates to ensure recruitment targets are being met.
• Develop a contingency (“Plan B”) strategy in case recruitment needs to be improved.

Remember: Meeting recruitment targets is critical to ensuring the study is adequately powered to detect a statistically significant difference.