Participant Recruitment Resources

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Successful participant recruitment for clinical trials needs careful planning and resourcing. Here are some practical tips and resources to help improve your success rate.

Helpful Suggestions for Participant Recruitment

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.

Involving patient and consumer representatives in the early 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 be involved in research in different ways including as members of advisory panels, helping to design protocols, helping with drafting Participant Information Sheets and Consent Forms, and assisting in grant applications. Consumers can also assist with communicating clinical trial results to study participants and community groups. 

1 Clinials, 2021. 5 reasons why clinical trials fail to finish. Accessed 2 Aug 2024:  https://clinials.com/the-5-reasons-why-80-of-clinical-trials-fail-to-finish-and-how-clinials-will-change-that-stat/

2 Todd AL, Nutbeam D. More and better clinical trials in health care: focusing on people, not just systems and processes. Medical Journal of Australia 2023; https://doi.org/10.5694/mja2.51856

Some other helpful suggestions include the following:

·  Know your target audience: Identify your target population (demographics) and where they are likely to look for information about a clinical trial. For example, with the right approvals you might be able to look at medical records and health registries to identify participants who may be eligible for your trial.  They could be attending local hospitals or clinics, or be accessed through medical or allied health professionals. 

·  Develop a marketing plan that reaches your target population and their communication preferences.

·  Develop mechanisms to pre-screen and screen potential participants. You can have a screening process in place via a dedicated recruitment team at your site or facility, through email contact or through direct contact from research staff. Prepare a thorough screening sheet based on the inclusion and exclusion criteria contained in the trial protocol. If appropriate, ensure health or medical expertise is available to allow staff to seek answers prior to a screening visit being booked. Include cultural and language considerations when planning your discussions with potential participants.

·  Fast-track the process for 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
  • study information – some sites send the Information and Consent form to allow the participants to review prior to their appointment.

    • Contact the participants prior to their visit and confirm their appointment.

    ·  Develop and implement a tracking system for all referrals, screened and booked participants.  Always ensure participants’ confidentiality and privacy.

    Approaches to Improve Participant Recruitment in Clinical Trials

    1. Review the protocol’s inclusion/exclusion criteria to be clear about participant eligibility
    2. Reduce the number of assessments that are not part of usual standard care
    3. Engage with and educate external referrers
    4. Use a clinical trial app that helps people find your trial
    5. Review medical records and sit in on clinics to learn more about target participant groups
    6. Spread the word to colleagues about your trial
    7. Share trial information on hospital notice boards/clinics
    8. Advertise on websites
    9. Use social media groups
    10. Review participant screening sheets for screen failures and site recruitment rates to identify any necessary changes
    11. Develop and implement an action plan to reduce participant screen failures
    12. Create a recruitment toolkit that includes flyers, inclusion/exclusion pocket cards, participant brochures to help promote the trial
    13. Create newsletters and communication strategies
    14. Share the enrolment process and success of high enrolling clinical trial sites

    Initial Contact

    An important factor in recruitment success is how a participant is initially contacted. After all, without a successful initiation, a participant will not join a trial.

    Digital Recruitment

    As consumers and patients increasingly use online options for medical and treatment information, digital recruitment campaigns have become common place in clinical trials.

    If you are using social media and search engines, it is important to research targeted keywords for your participant populations. For social media advertising, tailor messages to your target audience: you need to send the right message to the right people.  Think about what language and key points will be most appropriate. You might also consider enlisting some help from a person with digital marketing experience.

    Clinical trial apps like ClinTrial Refer can also provide fruitful opportunities for recruitment.

    Use a patient database

    Evaluate your own patient database if this is available for your trial. Alternatively, your site might have designated staff for recruitment pre-screening, who can connect patients with clinical trial opportunities.

    Share your trial information

    Patients respect their clinicians and might prefer to hear about clinical trial opportunities from them. Patients also trust their recommendations and advice about participating in trials. Consider putting together materials about your trial designed specifically for doctors, nurses and other healthcare professionals.

    Use pre-existing relationships between your site and local hospitals or general practices to spread the word. Meeting with them face-to-face, or connecting with health staff at conferences or workshops can be a valuable way to get the message out.

    Connect with community and patient advocates

    Present to local patient support groups or community groups or attend community markets and fairs.

    Engage a clinical trial participant recruitment company

    If you lack the resources to undertake recruitment, consider engaging a recruitment company. Meet with several to discuss your budget and needs; they may offer digital advertising, access to a database, or connect you with a not-for-profit organisation that undertakes work in the therapeutic area being researched.

    Improving Participant Retention

    Once a person has been successfully recruited into a study, it is really important that they complete the trial.  To help retain trial participants, ensure you:

    • Schedule appointments appropriately, send reminders, use open communication
    • Send reminders to complete tasks such as participant diaries, home-based activities or tests, and/or interviews
    • Implement communications that streamline the information flow for participants and provide after-hours support
    • Regularly follow up with participants and ask for feedback to check they are OK
    • Share relevant information directly with trial coordinators and other team members.