Five Elements Impacting Recruitment and Retention: How Strategic Site Partnerships Can Prevent a Cascade of Challenges

Recruitment and retention may appear to be simplistic in their primary functions. However, for these two processes to be successful, they must be applied in a way that resonates with the individuals that are stepping up to participate, whether that be out of a desire to impact the health of others or to provide treatment options for their own health condition. By adding people to the equation, we are adding variables of infinite complexity. Thus, an absence of process or lack of experience in one area can significantly affect others, leading to a cascade of problems that undermine recruitment and retention plans.

This highlights the need for strategic collaboration. By understanding the interconnected nature of these processes, sites, sponsors, and CROs can better strategize and optimize their operations, leading to more successful and efficient clinical trials.

Five Elements Impacting Recruitment and Retention

1. Study team capacity: Multitasking is a myth

Effective recruitment, screening, and retention require a consistent and focused approach. Multitasking is a myth, and a potentially detrimental one when it comes to clinical trials and those volunteering to participate. Different tasks require different skill sets. For example, the skills that are necessary to identify and pre-screen potential participants are different from those required for data entry and documentation. The skill to interact with people and connect are not the same skills needed to review data for completeness.

Thus, it is imperative that study sites have adequate resources matched to the requirements of the study to ensure they have a team with the appropriate skill sets for the study.

2. Site priorities: Balancing research and patient care

WCG’s 2023 Site Challenges Survey found that 51% of respondents work on more than 26 studies at any one time, and 21% manage more than 150 trials at once. That means many sites are working across a very large portfolio of studies alongside their patient care responsibilities. Patient care will take precedence in a medical setting over trial conduct. For people wearing two hats, the care demands of the day will typically dictate the day-to-day priorities. Proper planning would expect that a portion of the workload for a study will be deprioritized on a regular basis.

Balancing study responsibilities requires a systematic and realistic approach, often necessitating additional resources or support systems to manage trial operations.

3. Protocol complexity: It continues to increase

Clinical trial protocols have become increasingly complex. While this is great for the advancement of medicine and science, it makes the conduct of clinical trials more demanding. For example, Phase II & III protocols average 263 procedures per patient, supporting approximately 20 endpoints, and it takes 10 months longer on average to complete a clinical trial in 2023 compared to 2018.¹ It’s little surprise that 36% of respondents identified complexity as a pressing concern, behind only staffing and staff retention (63%) and trial enrollment (48%). As disease demographics evolve and the focus on patient safety intensifies, this complexity will continue to grow.

Sites are scaling their operations to meet these elevated requirements and are increasingly relying on sponsors for fit-for-purpose solutions.

4. Study technology: Disconnected tools

Technology has revolutionized clinical trials and it continuously creates additional challenges for study teams. The surplus of tools used across sites, sponsors, and CROs creates a lack of interconnectedness and requires additional focus to ensure systems are updated accurately. Often, study teams are being asked to learn new tech for each study and are becoming fatigued with technology. Sites, dealing with a wide range of studies, must adapt to various technologies. What was previously seen as a positive has quickly become a pain point.

Sites are already accountable for their own systems, such as EMR and CTMS. Asking them to learn a new system per new study is a substantial ask when aggregated across 10 studies, or more. Site study team adoption of technology for a study is directly proportional to the value that technology brings and the support provided by the sponsor requiring it. When requiring a study team to utilize a new technology, sponsors should include resources dedicated to managing these systems effectively whether that is in-sourced or outsourced. In the end, the study teams need to know where to go if technology doesn’t work as intended.

5. Operational structure: Bridging the gaps

As protocols grow in complexity, sites that are otherwise well qualified to perform on a study may lack specific equipment, a core specialty, or diagnostic tools. This makes it difficult to align day-to-day site operations with the sponsor objectives. It could even mean not being able to utilize that site, potentially missing the opportunity to tap a necessary patient demographic.

Sponsors and CROs should include in their start up planning resourcing to provide the support required to fill these gaps. Such support can be the difference between a successful trial and one that fails to meet its enrollment targets.

Support, Training and Communication

Addressing these challenges requires a unified approach. Site study teams have agreed to sign up for a clinical trial and conduct that trial per the protocol. When a study also requires new technology or accelerated timelines, expecting those study teams to tackle those challenges in isolation will not yield the best results for your study.  

Begin with an open line of communication to ensure that site capabilities align with sponsor expectations. If everyone agrees and focuses on the trial’s outcome as the goal, then it becomes easier to achieve that goal when those challenges arise. And they will arise.

For some sites the solution is simply a lack of bandwidth to dedicate the time necessary to ensure successful recruitment or retention. In these cases, additional resources applied to the site may be the answer. However, for most sites the answer is more complex. It is usually a combination of factors which ultimately result in the site’s inability to prioritize a given study to match the ever-decreasing study timelines. Stretched and taxed resourcing puts even more importance on training. Every study and site need training to conduct a study. Efficient training helps studies run smoothly while minimizing staff frustration and burnout. A properly trained team is better able to set priorities and manage complex protocols. They are also able to better optimize new technology.

WCG Can Help

The demand of clinical trial volume and complexity often outpaces site capacity and expertise. As a result, many sites may experience challenges supporting clinical research.

WCG can leverage our industry experts to review your study design to provide fit-for-purpose solutions that are designed to help you meet your study objectives. We combine strategy, tailored approach, and a passionate team of professionals that are ready to help you meet your goals.

Want to learn more? Contact us today to chat with our experts.

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References:

1. WCG Data Intelligence Platform & Tufts 2022 CSDD