Strategically formulating a plan for the effective management of patient recruitment and enrollment for clinical trials streamlines processes. There are recurring factors that impact successful completion of these activities, regardless of the targeted patient pool or indication. According to the National Institute of Health, “When choosing a recruitment strategy, one must consider the study population and the appropriateness and cost of the recruitment method before beginning the trial. There are many different recruitment methods, including media (i.e., television, radio and newspaper), physician referrals, press releases, fliers, random mailings, cold calls and internet. Patients are unlikely to enter studies that they find difficult to understand and that require multiple follow-ups. “ 1. There is a solution to navigating these challenges: realizing that when it comes to driving patient recruitment and enrollment in clinical trials, there are preceding and succeeding procedures, and everything connects.
Basic, high-level processes for a site implementing a clinical trial include:
- Completing a FQ (Feasibility Questionnaire)
- Negotiating a contract and budget
- Signing a CTA (Clinical Trial Agreement)
- Executing the study start-up
- Recruiting potential participants
- Actively enrolling and retaining patients
- Finalizing study close-out
Working towards meeting enrollment goals is mid-stream.
“Think of the feasibility questionnaire like a resume,” advised Marisol Ocasio, Director of Patient Enrollment at Elligo. “Sponsors and CROs are looking for a site’s credentials and it enables them to know if a site is the right fit for the study.” As a site, it’s important to derive an accurate enrollment estimate. Approaches include an in-depth analysis of the protocol, database search for inclusion/exclusion criteria and copious research on the indication itself.
“Not every study is a good study for you,” Marisol counseled. “It’s OK to walk away from studies. Sometimes, when you’re looking at your study pipeline, walking away may be something that’s really hard to do. It’s important you make decisions based on data, and not impulse.” Take time when filling out the FQ to ensure your site has the necessary infrastructure, resources and personnel in place to support the trial. Once you receive the final protocol, circle back to the FQ to review and if needed, make updates to initial enrollment predictions.
Sites can increase their database potential by treating it as a “goldmine” that needs constant upkeep. Have a dedicated recruiter maintain patient engagement and verify that contact information and medical history data is current.
Once a site has been selected by the sponsor or CRO, contract and budget negotiations commence. Keep in mind that when negotiating a contract, time is money. It’s advisable to not focus entirely on the per-patient budget and increased fees. Understand whether the enrollment goal is fixed or competitive. When evaluating a budget, make sure the following items are included:
- Chart review
- Pre-screen logs
- Network referrals
- Source development
- Advertising
Other marketing channels to use to promote the study include traditional/digital advertising, social media, national patient databases and community outreach.
Enrollment is the time to connect with potential patients, address their concerns and alleviate their anxieties. This is also when study protocols are assessed in order to formulate pre-screening questionnaires, based on inclusion/exclusion criteria and other complex protocol requirements. Almost 80% of clinical trials fail to meet enrollment timelines (Drug Development Tech, 2012) and 48% of sites under-enroll (Tufts, 2013). Elligo provides cost-effective, strategic assistance to clinical trial sites at study start-up or when a site is in need of additional support. Enrollment Center specialists help alleviate the pressure seamlessly and professionally on study staff with a comprehensive suite of recruitment and retention services.
Study close-out should not be the end of your patient communications. Conduct interviews and surveys to ensure that patients have had a positive experience. Continuing to engage with them will increase the likelihood of them returning to your office and participating in other clinical trials.
Conducting successful clinical trials that have a patient-centric focus and produce good, quality data is the goal for research sites, sponsors and CROs alike. Recognizing that there are myriad moving parts to the process, each requiring diligent attention, is key to propelling site and study success.