Even though the COVID-19 pandemic raised global awareness of clinical trials, most adults have never seen an advertisement recruiting volunteers to participate. In the U.S., half of the adult population is unaware of the clinical trial process and the numbers are even lower in most other countries. No surprise then that worldwide, clinical operations professionals have a long-standing patient recruitment issue. They experience several challenges enrolling and retaining study volunteers who face persistent societal and logistical barriers to entry. Since low enrollment is the major cause of early termination of clinical trials termination, including patient perspectives early on is vital for sponsors who need to capitalize on their R&D investments. However, sponsors must deal with new challenges posed by the pandemic to screen, educate, engage, and enroll patients remotely.
Misconceptions as barriers to participation
Patients rarely enrol in clinical trials for many reasons including those related to how clinical studies are perceived by lay persons. Some patients believe that no studies related to their condition exists in their area. They may also think that trials are only conducted in large cities, leaving out those living in rural areas who must travel great distances for care. Would-be study subjects sometimes worry about the level of respect they will receive as participants and whether they will be treated as guinea pigs. The patients may even be cautious of surrendering control of their treatment during the length of the study. So, it’s important to address these concerns when recruiting for a patient-centric trial.
Diversity, equity, and inclusion
Research findings are most meaningful to the groups studied in a clinical study. In this regard, women, minorities, children, and other underserved groups are insufficiently represented in clinical trials. However, certain groups, such as children, the economically and educationally disadvantaged, the imprisoned, and those struggling with addiction are potentially vulnerable to coercion to participate or entirely excluded. Additionally, for many patients, language barriers limit communication with the clinical trial staff. To ensure more inclusive trials, safeguards must be included throughout the clinical trial process to guarantee the protection of the rights and welfare of diverse participants. Refer to this article for our perspective on the need for ensuring diversity, equity, and inclusion in clinical trials.
Reasonable inclusion and exclusion criteria
The inclusion and exclusion criteria must be defined in the study protocol. No individual or group should be excluded from the eligibility to take part in the study without a valid reason. On the other hand, no individual or group should be included unless they are likely to benefit from the research. In executing this strategy, clinical trial sites responsible for patient recruitment should exercise due diligence when it comes to identifying the right candidates for their study.
Key elements of a successful retention strategy:
For a retention strategy to be successful, the investigators should keep the below elements in focus:
- Treating participants with respect
- Identifying and overcoming barriers to retention
- Making sure that participants feel appreciated and establish rapport with them
- Including retention strategies in the budget
- Be persistent and document all attempts to contact the participants
- Consider amending the protocol or other procedures that participants find disagreeable due to religious, deeply rooted personal beliefs, or other reasons.
Retention is an ongoing process
Even if the recruitment goal is reached, it’s often short-lived victory. Researchers can expect to lose about 30% of study participants who drop out from brick-and-mortar clinical trials. It’s key to remember that retention is an ongoing process. It is a shared responsibility, and all clinical staff must be trained to understand the importance of maintaining up-to-date contact information of the participants. Sometimes, patients outlast staff members, so mastering long-term engagement and trust building are crucial to patient retention. It’s also important to make sure that informed consent materials are easy to understand, so that the participants know exactly what to expect from the trial. Afterall, the participants must complete the study to ensure that the data and information can be included in the final analysis.
Reasons for dropouts and finding workable solutions
Having spent a sizeable effort recruiting participants, you’ll want to make sure they stick around for the life of the study. Some dropouts are unavoidable, but a multitude of things can occur that pose a threat to your retention rate. The luckiest investigators receive formal notice, while others just get ghosted—dropouts just disappear, never again showing up for appointments or returning any communication. Whenever notice and feedback is given, there is an opportunity to learn about why participants leave.
Being aware of how the patient is feeling is the first step toward addressing factors that lead to attrition. Think of retention as an ongoing relationship that needs constant nurturing. To foster this relationship, two-way communication needs to be established with the participants. There should be a single point-of-contact (SPOC) that they can trust and turn to with any questions and concerns. It is optimal to address patient concerns immediately, objectively, and empathetically.
Accommodate patient schedules, meet them where they are
When trying to bring patients into a clinical trial, it’s important to allow them to schedule their appointments. Although this may seem simple, remember that most people have jobs and family commitments. In addition, patients may be apprehensive about being involved in a lengthy trial that may last several months or more. During the recruitment process, it’s important that investigators listen to the patient’s concerns so that they can assess how best to accommodate them. Finally, consider flexible scheduling. Extended or weekend hours may accommodate more patient schedules and increase their likelihood of keeping appointments and continuing with the protocol.
Maintain a positive attitude and retain enthusiasm
For your participants to have a positive attitude about the trial, your staff also needs to have a positive attitude all through the study. A lot of excitement is built up at the start of a clinical trial, but the excitement can diminish over time, especially in long-term studies. Keeping patients interested in the trial begins with the study staff. Making sure that your staff maintains enthusiasm could benefit participation.
Embracing shifts in clinical trial designs in the new normal
The COVID-19 pandemic accelerated the adoption of patient-centric clinical trials. In traditional brick and mortar trials, patients were expected to visit sites multiple times. Sponsors are learning from factors that delayed or halted clinical trials during the pandemic including lower than ever access to study participants. In the new normal, sponsors will need to lean into technological advances that helped successful studies gain and maintain access to volunteers who have competing interests for their time and focus on addressing prevalent barriers to participation. Adopting compliant clinical operations technologies can improve recruitment and optimize resources to avoid shutting down in the future.
Digital strategies to accelerate remote patient enrolment
There are several available digital strategies for operating and participating in clinical trials, but they each have their limitations. Despite the large market, few eClinical tools provide flexible, modular, compliant solutions that reduce cost, increase speed, and ease the logistical burdens associated with study participation while improving the user experience for the staff and trial volunteers. The Jeeva™ eClinical Cloud is one such platform. It is a human-centric, bring-your-own-device (BYOD) software-as-a-service (SaaS) platform that allows volunteers to conveniently complete clinical trials from wherever they live or visit. The Jeeva™ eClinical Cloud enables hybrid and fully decentralized clinical trial protocols at scale and embraces the potential of digital technologies to generate reliable clinical evidence, minimize risk, ensure compliance, accelerate patient recruitment, retention, and maximize patient diversity, equity, and inclusion.
To keep up with the demand for new therapies in a post-COVID-19 world, clinical researchers, CROs, biopharmaceutical sponsors, academic medical centers seeking longevity will need to adopt proven digital strategies that increase the chances of study success. Filled with features that patients and staff prefer, such as automated enrollment workflows, eConsent, electronic patient-reported outcomes (ePRO), electronic clinical outcomes assessments (eCOA), bi-directional communication, adverse event reporting, and multi-site reporting from a single dashboard, Jeeva™ helps clinical researchers manage studies with a simple per-user subscription basis. Whether short-term or long-term, cross-sectional or longitudinal, interventional or observational studies, the Jeeva™ eClinical Cloud can be accessed on any browser-enabled mobile device and rapidly configured to fit most clinical trial protocols.
There is so much more to recruitment and retention than what one article could cover. Hopefully, the information given here serves as a good starting point to build up your recruitment and retention strategy.