Recruiting specialty volunteer populations for early-phase clinical trials.
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.
Because of physiological and lifestyle disparities, different populations may demonstrate widely varying responses to drug therapies. To safeguard those for whom standard requirements may not offer sufficient protection, special populations provide evaluation of factors such as dosage or dose interval modifications to address these differences. For example: One estimate says that 15–20 percent of people over the age of 65 take multiple drugs concurrently, which makes drug interactions of particular concern. Because geriatric populations respond differently than younger patients to drug therapy, it is imperative to procure clinical efficacy and safety data for these populations in early drug development.
Furthermore, expanding sales growth in global pharmaceutical markets is driving drug development to Europe and Asia. Therefore, 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.
Recruitment of special populations can be especially challenging, but following a few basic practices will improve your results. In addition to identifying the appropriate study participants, the right partner can help minimize screen failures due to multiple exclusion/inclusion criteria.
Work with an experienced partner
An experienced partner can effectively target hard-to-recruit populations such as the elderly, post-menopausal, hypertensive, Type II diabetics, healthy smokers, obese and Japanese subjects.
Such a partner will demonstrate a successful track record and can provide metrics regarding:
- Number of studies completed
- Database size and number of active healthy volunteers
- Recruitment timelines and strategies for special subject populations
- Communicate effectively
If you’re a sponsor, it will be of utmost importance to work with a CRO that is transparent about timelines and can guide your expectations. An organization that has completed multiple studies with similar types of populations will have a baseline understanding of recruitment challenges. Such a partner can thus 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. Therefore, 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.
Inquire about the 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. Furthermore, consistently recruiting and performing multiple trials keeps the volunteer database active.
Consider the 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. For example, facilities in larger cities tend to recruit from ethnically diverse, large populations that have 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
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 an integrated solution
When you need volunteers for your study, look beyond the CRO’s ability to recruit large cohorts of volunteers; examine its track record of complete study delivery, including the expertise of its medical directors and project management capabilities. The right partner can also provide guidance on 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, rely on Quotient Sciences. With a proven track record that spans more than 30 years, we offer numerous resources to drive the success of your program:
- Over 1,300 Phase I studies completed
- 245 beds globally
- Industry-leading Phase I medical directors
- Ability to rapidly recruit large cohorts of volunteers
- 99 percent of studies start on time
- 98 percent enroll with full cohorts