Earlier this month, representatives from research sites, sponsor organizations, CROs, and regulatory agencies gathered in Hollywood, Florida, for the 2023 Global Site Solutions Summit. In conjunction with the Society for Clinical Research Sites (SCRS), attendees came together to discuss best practices for research sites through ideation sessions, workshops, and focus groups.
During this year’s conference, Slope’s VP of Research Site Development, Matt Smith, joined other industry leaders for a breakout session titled “Survival of the Fittest: Strategizing Business Development.” During the panel discussion — which drew over 100 attendees — Matt and fellow panelists shared innovative methods for optimizing site business practices that enable researchers to develop a more robust clinical trial portfolio. In case you missed the conversation, here are three important takeaways.
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 only a small fraction of what the site believes that it can achieve.
So how can sites differentiate themselves in a competitive market? Matt and other panelists agreed that creating a site “credit score” that bolsters sponsor trust in a site’s ability to enroll patients for their trial is key. 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 3 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 2 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.
According to panelists, 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.
Panelists suggested 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.
Purely transactional sponsor-site relationships can hinder the potential for long-term partnerships. In order to build rapport and trust with sponsors, panelists recommended 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.
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.
Sponsors are eager to know what systems and processes sites are using to improve their operations. Slope offers an inventory management solution that helps sites avoid rush shipments and visit deviations due to lab kit shortages — coupled with a sample management solution that can eliminate concerns around adherence to the most current version of the protocol, and oversight of the biospecimen journey. Slope can support your business goals by driving efficiency and compliance, enabling better collaboration with study stakeholders, and capturing key inventory and sample data that will be significantly valuable to prospective sponsors.
To learn more about our clinical trial execution platform for managing clinical inventory and patient samples — which is free for sites — click here.