Three Practices to Unlock Success for Clinical Trial Sites

It should come as no surprise to research sites that trial sponsors are fighting tooth and nail to find the perfect research partners, especially in competitive therapeutic areas like oncology and rare disease. At the same time, these very same sites are juggling mounting responsibilities and expectations in their clinical trial operations. In this competitive and demanding landscape, how can research sites navigate these operational and business development challenges, ensuring that they are a top pick for the most coveted study opportunities?

Based on my decade of firsthand experience supporting research site growth and development in various capacities, I have formulated a series of best practices for sites that are looking to optimize their business strategies in order to develop a more robust clinical trial portfolio. 

Build a “Credit Report” for Your Site

In life, lenders require lessees to have a credit score that demonstrates their financial dependability. But in the context of clinical research, many sites lack a comparable equivalent that showcases the full scope of their capabilities to study sponsors. When investigators bid for a trial, they typically fill out a feasibility questionnaire that offers a prediction of how many patients they can enroll based on the clinical indication, enrollment criteria, and more. Most sites, however, struggle to provide any proof to support these enrollment numbers, so sponsors and CROs will formulate their own conservative estimation of the enrollment at a specific site that is typically only a small fraction of what the site believes that it can achieve. 

So how can sites differentiate themselves in a competitive market? I recommend creating a site “credit score” that bolsters sponsor trust in a site’s ability to enroll patients for their trial. Pulling enrollment metrics from previous trials in the same therapeutic area or clinical indication is one way to demonstrate credibility, but the presentation of the data matters. For instance, if a sponsor reaches out to a site about an Alzheimer’s study, but this site only enrolled three patients in their last Alzheimer’s study, they should attempt to contextualize this data. Perhaps this site was only contracted with the previous sponsor to enroll two patients, so this site has a 130% contract-met percentage — and on studies with low enrollment, this institution could have been a top enroller. By qualifying their data, sites can tell a compelling story about their ability to recruit and retain patients for a specific clinical trial. It is important, however, that sites set achievable goals. Overpromising to a sponsor and then not being able to deliver on that promise can harm a site’s reputation and have negative implications for a sponsor relationship.

Sponsors are interested in more than just patient enrollment numbers. Patient demographics are also crucial to study sponsors who are looking to test the safety and efficacy of their drug on a diverse population. Being able to demonstrate access to heterogeneous populations based on factors like age, ethnicity, sex, and more can position a site as a valuable player on a trial. Sponsors also want to know what a site’s current pipeline looks like — not just to gauge a site’s level of expertise in a certain therapeutic area, but to also determine if the institution is supporting any other trials in the same indication that could potentially compete for the same patients.

I suggest presenting data in the form of a site C.V. or a standardized report that offers prospective sponsors an overview of the expertise, diversity, and patient accessibility that their organization can contribute. This document can include a list of standard information and capabilities such as equipment on hand, staff experience, and any other differentiators that demonstrate success and quality of work. Evidence of patient engagement on the institution’s website and across other forums is also critical, as this may bode well for enrollment and retention. 

Invest in Sponsor Relationships

Purely transactional sponsor-site relationships can hinder the potential for long-term partnerships. In order to build rapport and trust with sponsors, I recommend that research sites seek out opportunities to offer additional support to sponsors, ultimately fostering a deeper and more mutually valuable relationship. 

The following practices can enable sites to differentiate themselves as partners rather than vendors. 

1. Ask prospective sponsors about their “ideal site profile” so that they can then identify opportunities to address specific study needs. For instance, site networks with facilities in multiple countries can evaluate their patient demographics across their entire operation, offering insights to sponsors as to which countries they should include in their trials.
   
2. Ask principal investigators or site directors to offer their expertise to sponsors by providing feedback around protocol design elements that could limit enrollment or complicate site processes.
   
3. Be vocal about resources that would help your site operate better. Perhaps sponsors can support staffing or enrollment with additional external recruitment efforts. 

These efforts can be supported by “zippering” — the process of aligning site staff with their cohorts on the sponsor side who may have similar roles, similar backgrounds, and/or similar interests. Through this approach, sites are no longer relying on one or two individuals to own the sponsor relationship — they’re relying on various touch points throughout their organization, each one focused on fostering a different facet of a broader relationship. Everyone at the site can impact study selection, so maintaining a positive relationship with sponsor and CRO counterparts across the entire organization can maximize credibility. 

Site management organizations (SMOs) should supplement your relationship, but they shouldn’t replace it. SMOs can offer a strong value to sites who are looking to bring in more studies and build relationships with sponsors and CROs. They can help you make introductions with sponsors, but they should not be a standalone siloed business development vehicle.

Demonstrate to Sponsors What You Are Doing to Reduce Risk

Sponsors are eager to know what systems and processes sites are using to improve their operations. A centralized inventory management solution can help sites avoid rush shipments and visit deviations due to lab kit shortages, while a site-led sample management solution can also eliminate concerns around adherence to the most current version of the protocol and oversight of the biospecimen journey. By implementing this kind of technology, sites can demonstrate efficiency and compliance that will help them achieve their business goals. Enabling better collaboration with study stakeholders, and capturing key inventory and sample data, will also be of significant value to prospective sponsors.

In navigating the competitive clinical trial landscape, research sites face the challenge of not only meeting sponsor expectations, but also showcasing their distinctive capabilities. Presenting what makes them stand out in a site credit report will help them differentiate from the crowd. Emphasizing relationships over transactions will help sites deepen relationships with sponsors. Finally, sites can leverage technology to reduce operational risk, thereby eliminating concerns in the minds of the sponsor. By adopting these practices, research sites can strategically position themselves as top picks for the most coveted study opportunities.