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Clinical Pharmacology , Human ADME , First-in-Human , Healthy Volunteer Trials , Early Development , Translational Pharmaceutics

How to recruit specialty volunteer populations for early-phase clinical research

Clinical Manufacturing Aseptic Expertise at Quotient Sciences

Participant recruitment is one of the biggest bottlenecks in clinical research today. 

In early drug development, effective volunteer recruitment is critical for building a robust package of clinic trial data, ensuring scientific validity, containing study costs, and maintaining timelines. In studies that require specific types of volunteer populations, it’s important to develop a focused plan for recruitment.

Different populations may demonstrate widely varying responses to drug therapies due to physiological, lifestyle, or other disparities. To safeguard those for whom standard requirements may not offer sufficient protection, special populations provide an evaluation of factors such as dosage or dose interval modifications to address these differences.

For example, individuals over the age of 65 are more likely than younger individuals to take multiple drugs concurrently, making drug interactions of particular concern. Because older populations respond differently than younger patients to drug therapy, obtaining clinical efficacy and safety data for these populations is critical in early drug development.

Furthermore, growth in global pharmaceutical markets is driving drug development in Europe and Asia. Multi-ethnic approaches to clinical trial programs, such as ethnobridging for native Asian populations living in other countries, must account for cultural differences to satisfy international regulatory authorities.

If you’re a sponsor, it will be of utmost importance to work with a trusted contract research organization (CRO) that is transparent about timelines and can guide your expectations. 

An experienced partner can effectively target hard-to-recruit populations such as the elderly, post-menopausal, hypertensive, and healthy smokers, to name a few.

An organization that has completed multiple studies with similar types of populations will have a baseline understanding of recruitment challenges and can provide an honest assessment of the time expected to recruit the full cohort. When studies have stricter criteria or more screening procedures for qualification, recruitment will require more time. It’s important to find a partner that provides a realistic, trust-based approach to recruitment rather than one that promises to quickly recruit every participant.

In addition to identifying appropriate study participants, the right partner can help minimize screen failures due to multiple exclusion/inclusion criteria. 

Such a partner will demonstrate a successful track record with metrics including:

  • Number of studies completed
  • Database size and number of active healthy volunteers
  • Recruitment timelines and strategies for special subject populations 
  • Communicate effectively

Sponsors may consider the following five tips when it comes to interviewing and partnering with a CRO for their early drug development needs.

Inquire about the volunteer database

When rapid study startup is critical, a robust database provides an immediate starting point for recruitment. A large database demonstrates that the CRO has access to an adequate population of volunteers who understand clinical research and are amenable to participating. Consistent recruitment activities and a database of multiple trials also can help keep volunteers active.

Consider your CRO's location

Whether your trial must be conducted at a single site or multiple sites, you may want to consider the location of the sites available and their advantages and disadvantages. Facilities in larger cities tend to recruit from more ethnically diverse populations or those with better access to public transportation options. The longer the facility has been in existence, the more established relationships it will have with the local community and population.

Know what questions to ask your CRO's

To determine how the CRO will prioritize your study, ask whether it is recruiting for multiple studies of the same kind concurrently. If so, your study would compete with others for the same volunteers and consequently have access to a smaller pool of potential participants, which could delay your recruitment completion. Ask about recruitment and screening timelines, because extended timelines could indicate difficulty recruiting that population. Determine if full trial cohorts can be enrolled at one time or if there is a need to divide them into sub-cohorts for admission, which could be another indicator that the site has difficulty enrolling a specific population.

Employ best practices regarding patient safety

If you have concerns about volunteers participating in overlapping studies, work with a partner who uses a registry that tracks volunteers and their participation in trials, including the date of the last dose of a study drug. This information will help establish a sufficient wash-out period, during which the participant receives no active medication. Such registries are confidential and established through fingerprinting, and they enhance patient safety as well as facilitate data integrity.

Find a CRO that can integrate services

Look beyond the CRO’s ability to recruit large cohorts of volunteers and examine its track record of complete study delivery, including the expertise of its team of medical directors and project managers, as well as other capabilities. The right partner can also guide protocol development and study design to maximize your clinical data output, and rapidly deliver data and insights quickly to move you to the next milestone.

When you are looking for a partner who is dedicated to Phase I trials and early development, choose Quotient Sciences. 

To find out more about our clinical pharmacology capabilities, get in touch with us today.