How To Work With A Research-Naïve Clinical Trial Site

By Amy Bland, COO, Curo Research

As the demand for diverse and inclusive clinical trials grows, many clinical research sites with no prior research experience are interested in participating. While these research-naive sites come with challenges, they also present tremendous opportunities for sponsors willing to invest in their development. Sponsors can turn these new sites into valuable long-term partners by providing them with the necessary training and support. This article explores the potential of new clinical research sites, their unique advantages, and the challenges they face, as well as offers actionable strategies sponsors can use to maximize their success.

The Upsides To Working With New Research Sites

New research sites bring unique strengths that make them an excellent choice for expanding clinical trials. One of their most significant advantages is offering sponsors access to untapped patient populations, particularly in suburban or rural areas often overlooked by established research networks. These regions frequently consist of diverse populations eager to participate in clinical research, offering sponsors an opportunity to improve inclusivity in their trials.

Engaging new sites also allows sponsors to reduce competition for patients. Compared to larger, more established sites juggling multiple trials simultaneously, newer sites typically focus on executing a single study. This dedicated focus can reduce or even eliminate competition for patients as well as translate into faster patient recruitment and more streamlined operations, ultimately accelerating trial timelines. Additionally, new sites often feature highly motivated teams eager to contribute to medical advancements.

The Challenges Faced By New Sites

Despite their potential, new sites have challenges that sponsors must address to ensure success. One major hurdle is the need for extensive training on clinical research regulations, SOPs, and protocol adherence. Without prior research experience, site staff may mishandle the complexity of clinical trial operations, leading to increased protocol deviations, especially during the first few enrolled patients.

Additionally, new sites often lack familiarity with essential systems, such as electronic data capture (EDC) tools and clinical trial management software (CTMS). They may require on-site support during critical milestones like the first patients’ randomization, consent, and follow-up visits. These knowledge gaps can lead to delays and demand higher resources; sponsors must anticipate an initial learning curve.

Another challenge is the unpredictability of site performance. Given a new site’s lack of a track record, sponsors may find difficulty gauging metrics like enrollment rates, subject retention, data quality, and protocol adherence. Sponsors must prepare for this uncertainty while building trust and confidence in the site's abilities.

Strategies For Maximizing Success With Research-Naïve Sites

Sponsors can take several proactive steps to support new sites and set them up for success.

1. Careful Site Selection

Selecting the right site is the first step toward a successful partnership. Sponsors should approach site selection as a candidate would for a job interview, which includes assessing responsiveness, communication, and capability. For instance, a site that promptly responds to requests but takes time to gather the required information may need guidance. However, delays combined with poor communication may signal an overwhelmed or underprepared team.

Considering staff longevity during site evaluations also can provide insight into stability. A site with at least one team member who has been with the organization for three or more years offers some assurance of continuity, a critical factor given the high turnover rates often seen at clinical research sites.

2. Comprehensive Onboarding

Once selected, new sites benefit tremendously from thorough onboarding and training programs. Sponsors can develop site-specific training initiatives that include:

• GCP Training: Incorporating real-world examples to make guidelines relatable and actionable
• Protocol-Specific Workshops: Highlighting common pitfalls and best practices tailored to the trial
• Mentorship Programs: Pairing new sites with experienced ones to provide guidance and support

Regularly scheduled virtual meetings can establish an ongoing support network, giving sites a platform to ask questions and share insights as the trial progresses. To further enhance communication, sponsors can provide updated contact sheets quarterly, ensuring that site teams always have access to the most current information.

3. Tools And Resources

Equipping new sites with practical tools and resources can help them navigate trial complexities more effectively. For instance, detailed checklists for site initiation, monitoring visits, and regulatory compliance can streamline processes and minimize errors.

An example checklist for site activation might include:

• Book a conference room for meetings.
• Ensure internet and electronic medical record (EMR) access.
• Block key staff schedules to ensure availability.
• Prepare required documentation and records for review.

These simple yet impactful measures can help new sites feel more confident and prepared, reducing the likelihood of avoidable delays or mistakes.

4. Building Strong Relationships

Establishing trust and open communication between sponsors and sites is critical for long-term success. Regular check-ins, prompt responses to site inquiries, and constructive feedback go a long way in building a collaborative partnership. Sponsors should view their relationship with new sites as an investment — not just for the current trial but for future collaborations.

The Bigger Picture

Embracing new research sites is about more than immediate trial success; it’s about driving growth and innovation in clinical research. According to Clinical Trials Finder, only 5% of U.S. physicians currently participate in clinical trials. Expanding the network of active sites can help increase enrollment, improve trial diversity, and ensure that more patients have access to cutting-edge treatments.

New sites bring fresh perspectives, untapped potential, and the ability to reach underserved communities. While the initial effort to onboard and train these sites may seem daunting, the long-term rewards for sponsors and the clinical research industry as a whole are undeniable.

About The Author:

Amy is the chief operating officer of Curo Research, where she is committed to promoting quality data collection, ethical patient treatment, and mutually beneficial relationships in clinical research.

With 13 years of experience — half of which was spent launching research-naive sites — Amy has developed expertise in starting and growing research programs. Her hands-on experience at the site level has given her unique insights into the challenges and opportunities faced by new research sites.

As a certified clinical research coordinator, Amy has been instrumental in achieving top enrollment rankings while maintaining over 90% data accuracy and follow-up compliance.

Her mission is to make clinical research accessible to any site motivated to learn, fostering an environment where research becomes a widespread and viable option for sites and patients alike.