Keys to Design a Successful Patient Recruitment Strategy

Recruitment strategy is critical to the success of any clinical trial, as it ensures adequate participation and enables meaningful results to be obtained. This article reviews the key elements of the systematic three-tiered approach that any effective patient recruitment strategy must address: creating awareness of the study to attract the attention of potential participants; fostering the enrollment process; and ensuring retention and engagement.

1. Creating Awareness

Most investigators maintain or have access to a database of patients they see on a regular basis. This database/clinic list often is the first place where potential patients are pre-screened against the protocol requirements. In some countries, pre-screening can only be conducted after ethics committee (EC) approval of the study. Therefore, it is important to understand this caveat while reviewing the expected enrollment figures of study sites within these countries. Some examples of techniques used to create clinical trial awareness include:

• Direct to patient advertising (e.g., through word of mouth)
• Electronic advertisement (e.g., mail shots)
• Internet (e.g., social networking sites, websites, web platforms)
• Patient advocacy outreach
• Patient recruitment agencies
• Patient referrals

The Principal Investigator (PI) may decide to approach colleagues (e.g., this maybe in the same department or other hospitals) who work in the same field as the indication under study and request patient referrals. Often, there are clinicians who are interested in conducting the trial and can be added as Sub-Investigators at the study site. In some cases, the PI may be afforded the opportunity to present the study to their colleagues as a means of creating awareness, which may also result in patient referrals. Some examples of techniques used to create awareness are listed below:

• Pharmacy campaigns
• Presentations (e.g., conferences, public health lectures, interviews)
• Print advertisement (e.g., posters, brochures, journal articles)
• Radio & television advertisement

2. Patient Enrollment

The doctor-patient relationship is vital in developing trust and confidence in the study team. This rapport may prove extremely important in whether the patient continues their participation in a study. The Informed Consent process is also an integral part of the clinical research process. This step ensures the patient is given enough time to review the trial information and that their concerns can be properly addressed. The ICF process is completed when both the doctor and the patient have signed the consent form. Subsequently, the patient will interact with the rest of the study team during study visits, until the end of the study.

3. Patient Retention & Engagement

The level of patient burden or inconvenience experienced by the patient whilst on the study may influence the clinical trial’s retention rate. To alleviate some of this burden, the following techniques can be employed:

• Caregiver inclusivity ensures those supporting patients are kept informed and involved in the study process and study requirements.
• Providing patient motivational tools such as thank you cards, birthday cards, milestone messages, bags to carry study medication or equipment, pens etc. All patient facing materials and tools must be submitted for EC approval.
• Patient prompts and reminders can be used to alert the patient about future visits. These can be through ad hoc phone communication or electronic alerts e.g., text messages and emails.
• Patient travel reimbursement should be incorporated within the budget during contract negotiations.
• Disseminating clinical trial results back to patients through patient portals.

Patient recruitment is everyone’s responsibility from CRAs, study nurses, Sponsor, CRO, pharmacy team and Principal Investigators. It is important that CRAs adopt a transparent and collaborative approach when interacting with study site staff. Experience shows that successful study sites are those who openly communicate with the Sponsor representatives about the challenges they are facing with the aim of working as a team to address any potential roadblocks. Thus, in addition to the three-tiered approach, it is vital to increase motivation at the study site level by applying some of the following techniques:

• Exploring together with the site team ways to get extra funding
• Provide proper training for First Patient In (FPI)
• Conducting motivational visits to discuss challenges and develop plans for addressing them
• Sharing good working practices from high enrolling sites via Investigator Meetings or Key Opinion Leaders input
• Circulating newsletters with study updates to keep the team informed on study progress, highlighting key developments and recognizing top performers or special milestones achieved.

The CRA should always discuss with each study site before implementing some of the techniques suggested to keep in line with local regulations and requirements.

Dr. Gillian Lakareber

From "A Guide to Patient Recruitment & Retention in Clinical Research: The 6 Core Outcome Factors Which Affect Patient Recruitment" is available in paperback and as an eBook for purchase on Amazon (https://www.amazon.com/Patient-Recruitment-Retention-Clinical-Research-ebook/dp/B09BXLM5V4) and 100% of the proceeds will be donated to charity for the education of children in rural areas across Africa.

About the Author:

Dr. Gillian Lakareber is a multi-award-winning clinical research professional with many years of experience in various roles within clinical research as a Clinical Research Associate, Patient Recruitment Specialist, Clinical Trial Manager and Project Manager. Dr. Lakareber has amalgamated her industry expertise in clinical research and theoretical knowledge from her Masters and Doctoral education to formulate a guide for the benefit of clinical researchers in this field. Dr. Lakareber is an ardent advocate in raising awareness of robust patient recruitment and retention strategies, with the aim of accelerating lifesaving interventions to patients.