Participant recruitment can be one of the biggest bottlenecks in clinical research.
In early 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 65 years old are more likely to take multiple drugs concurrently, making drug interactions of particular concern. Since older individuals can respond differently to drug therapy, obtaining clinical efficacy and safety data is critical in early development.
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.
How to choose a reliable CRO: Ask about these 5 things before you start your next program
In addition to identify appropriate clinical study participants, the right CRO partner can help minimize screen failures due to multiple exclusion/inclusion criteria. A CRO should 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
Here are five key factors you should look for - and ask - during the process of choosing a CRO partner for your early clinical program, with insight from our clinical teams in the US and UK.
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 with your CRO, whether they work with other partners, 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.
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.
When studies have stricter criteria or more screening procedures for qualification, recruitment will require more time. It’s important to find a CRO partner that provides a realistic, trust-based approach to recruitment rather than one that promises to quickly recruit every participant.
Determine what populations they can reach
Healthy eldery, post-menopausal women, and healthy smokers are just a few examples of hard-to-recruit populations that we have come across at Quotient Sciences. A CRO that has completed studies with these 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.
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.An experienced CRO partner can effectively target hard-to-recruit populations.
To determine how the CRO will prioritize your study, ask whether it is recruiting for multiple studies of the same kind concurrently. Ask about recruitment and screening timelines, and determine if full trial cohorts can be enrolled at one time or if there is a need to divide into sub-cohorts for admission. These could be indicators 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.
Find out more about Quotient Sciences' early clinical development services.
