Clinical Researcher—April 2020 (Volume 34, Issue 4)
RECRUITMENT & RETENTION
Danielle M. Desser, MS, CCRC, ACRP-PM; Courtney Dean Alexander, CCRC
Like learning to grow an exotic flower, subject recruitment, retention, and engagement is a delicate process in clinical research and full of potential stressors. Having a dependable principal investigator (PI) alongside a clinical research coordinator (CRC) can relieve these stressors. Especially in this current, unprecedented time in clinical research—with pandemic conditions prompting rapid adaptations for subject follow-ups while adhering to protocols and retaining subjects within the guidelines—finding ways to lessen site burdens is more important than ever.
The saying goes: “You have one chance to make a good impression.” Is this true in clinical research? Scouring countless medical records in order to identify a patient who meets a protocol’s stringent criteria is the first step of clinical trial recruitment. Identifying patients who seem ideal for a study on paper is one factor, but there may be personal and environmental obstacles that preclude enrollment.
Certain patients are voluntarily engaged the first time the study is introduced. They may have been recruited by phone, heard about the study on the radio, or discovered it through research on the internet and then sought out the study site. However, given the medical benefits and risks, subjects also need time and family input in order to accept this important voluntary healthcare opportunity.
Further, the informed consent process requires an engaged PI and CRC working together, knowing the protocol thoroughly, and taking the time to answer any questions together to recruit a quality patient.
Once a patient has been successfully recruited into a research trial, the job is done…right? Not exactly. Clinical trials require, at times, lengthy duration of involvement on both the patient’s and the site’s side. However, how does one keep a patient engaged in a trial that requires daily diaries, paper drug accountability logs, and multiple visits to the site requiring extra effort on the patient than what they would generally incur?
The focus of retention is to keep patients engaged in wanting to participate in the needs of the trial, explaining the importance of the role they play, and capturing the much-needed data to move the trial forward. Retention requires a certain level of TLC, compassion, understanding, and going above and beyond the general call of the job.
Patients who are engaged and educated, and who understand the purpose of the trial, remain more engaged and responsive throughout the duration of said trial, and better at maintaining compliance for moving the trial forward.
Even for trial participants who thoroughly understand the impact they are making on the future of medicine, researchers need to take a step back and remember these volunteers have responsibilities in their lives outside the realm of the study. Protocol deviations will occur, due to environmental and social factors beyond your subject’s control, but documentation is vital.
Studies have adapted over to time to include motivational phone calls for helping keep subjects on track at completing their patient diaries, take their medications, or remember their next follow-up appointment. In long-term studies, it can be a challenge for study staff to remind subjects year after year that they have an investigational device or are taking an investigational drug requiring careful data-collection efforts.
Fortunately, sponsors have created patient cards and reminders for alerting participants about visits that might not be expected until a year later, but are nevertheless key to the ongoing study’s progress. When the sponsor and study staff are actively engaged at set intervals, retention and engagement in clinical trials occur and could lead to a subject participating in a future trial.
Patient recruitment, retention, and engagement are the driving forces for capturing the much-needed data for the clinical trials we conduct. Without recruiting ideal candidates who truly understand the need for them to be compliant, complete visits, and communicate routinely with site staff, the data captured are likely going to become unusable, incomplete, and costly to both the site and the sponsor. Retention of more subjects who don’t become “lost to follow-up” is our ultimate goal, so going above and beyond to keep patients interested, on board, and up to date is paramount.
Engagement is probably one of the biggest issues sites face, because there is no single, standard tool that engages every single patient. Sites, in the past years, have had to become more creative and more involved in the engagement aspect—from offering perks while onsite, “swag” provided by trial sponsors, and routine follow-up not built into the budget between visits—so patients don’t feel “lost” in the process.
In conclusion, efficient and effective recruitment, retention, and engagement by sites combine to form a significant contributing factor in the success of clinical trials, the award to sites of future trials by impressed sponsors, as well as patients who would enroll into more trials with the same site.
Danielle Desser, MS, CCRC, ACRP-PM, is a Clinical Research Site Supervisor for IACT Health in Suffolk, Va.
Courtney Dean Alexander, CCRC, is a Clinical Research Site Supervisor for IACT Health in Columbus, Ga.