Driving site activation: How sponsors can enable research-naïve clinical trial sites

One day, I received a notification from MyChart that, based on my electronic health record (EHR), I was eligible for a trial at a large AMC. Once enrolled, I experienced first-hand how much time it takes for the busy site staff to engage with just one trial participant. For example, an RN being required to test me for a condition that is physically impossible for me to have due to a lapse in protocol logic, or the lack of a digital participant platform requiring the PI to play phone tag with me to check on a concerning side effect.

This experience exemplifies a critical challenge in pharmaceutical R&D: as trial demands increase, sponsors continue to rely on the same overburdened sites, resulting in delays and skyrocketing costs.

Today, most U.S.-based trials take place at a very small proportion of sites. In fact, an analysis of GlobalData’s trial database shows that nearly 63% of ongoing, U.S.-based trials take place at just 10 clinical trial sites. A 2023 survey report examines several challenges that can deter other sites from taking on more trial opportunities: staff turnover, patient recruitment challenges, and trial complexity.

Oft-proposed solutions to bolster site capacity include using EHR systems to support patient recruitment and data capture, simplifying protocols, and improving education about clinical research careers to attract new talent. These efforts are valuable but complex, requiring collaboration across pharma and biotech, healthcare providers, technology vendors, academic institutions, and other trial stakeholders.

Because of their complexity, it will take time for such initiatives to come to fruition, hopefully leading to a larger, more diverse network of experienced and efficient clinical trial sites in the future. In the near-term, though, there are three ways that sponsors can activate research-naïve sites: changing their site selection processes, minimizing the technological burden on sites, and taking a collaborative approach to patient recruitment.

Identify sites on factors beyond historical performance

A recent ACRP publication found that 20% of investigators will only ever do one industry-sponsored trial, with another study indicating that 44% of “one-and-done” investigators were not able to participate in additional trials despite their interest. This gap largely stems from sponsor processes, which rely on four main factors in site selection: access to and experience with the target patient population, research experience, and historical performance. These criteria disadvantage research-naïve sites that may have the potential to become trusted, long-term trial partners.

Beyond prior experience, sponsors should consider:

• Does the site have a more diverse population of patients?
• Does the site have greater access to patient populations required for other therapeutic areas, beyond the immediate trial need?
• Does the practice have a high volume of returning patients, and do they collect any patient experience data? Do these metrics suggest strong physician-patient trust, which could bolster enrolment?
• Are staff turnover rates low, allowing the site to retain talent that can better execute future trials?
• Does the site have existing infrastructure to support innovative trial models (e.g., platform, decentralized, pragmatic)? For instance, if the trial leverages a decentralized model, does the site already have a telehealth platform and remote monitoring equipment?

Sponsors can either gather this data directly from prospective sites during site selection or leverage broader platforms – such as clinical data registries – to understand patient populations across different practices.

Such efforts will require sponsors to rethink their site selection processes. PA has supported clinical research teams across the healthcare ecosystem with designing and implementing new ways of working – including helping an academic research site expand into a new therapy area, building a business case to drive adoption of platform trials, and working with a large pharma client to bring disparate clinical development teams into a single, streamlined function.

Choose trial technologies that minimize site burden

With 60% of site staff regularly copying data across up to 22 disparate trial systems per study, the proliferation of sponsor-provided technology platforms creates substantial site burden. Collaborating with research-naïve sites to overcome these technology challenges is critical for sponsors to build longer-term site relationships and encourage continued engagement in trials.

There are several ways that sponsors can ease the technological burden on sites. The first is by accepting existing site technologies for trial delivery whenever feasible. This may include eConsent, eSource, EDC, and other trial systems. In fact, GSK is currently developing a tool to assess site eConsent systems for use in their trials. In cases where a trial does require sponsor technology, sponsors must offer ongoing training and support. Amid 35%-61% annual turnover rates among site staff, sponsors should provide infrastructure to train new staff on an ongoing basis. Finally, sponsors can offer “Trial in a Box” platforms, which are designed to support research-naïve sites by providing access to online training, remote monitoring tools, and other resources.

PA recently worked with a global clinical research organization that operates thousands of trials per year to create a next-generation data platform that accelerates time to database lock and reduces site burden by improving data validation and monitoring through novel use of AI. These types of platforms can dramatically reduce both site burden and cycle times by improving data quality and completeness.

Take a collaborative approach to supporting patient recruitment

48% of sites identify patient recruitment and enrollment as a top issue, with nearly 80% of trials failing to meet their enrollment goals. While research-naïve sites can provide greater access to diverse patient populations, site staff may have little to no experience with patient recruitment and – at least in the short-term – may require sponsor support to develop recruitment infrastructure.

Sponsors can support sites with patient recruitment in several ways:

• Leverage digital recruitment strategies – including social media marketing and online disease communities – to create broader awareness about trial participation.
• Develop next-generation recruitment platforms. Many pharma companies have already developed such platforms – for example, Roche’s ForPatients and BMS’s Clinical Trials. However, new technologies like AI offer substantial opportunity to improve these platforms. For instance, PA recently helped a client transform their patient recruitment organization, with a focus on how they could leverage cutting-edge technologies like AI and consumer technology to fulfill enrollment targets.
• Partner with patient advocacy groups to drive trial recruitment. These groups can provide input on recruitment strategies, raise awareness of trials, and even recruit directly from patient registries. For example, one sponsor met their enrollment target in a matter of hours by recruiting directly from Friedreich’s Ataxia Research Alliance’s patient registry.

Clinical trials are ripe for transformation, particularly as technological advances give rise to self-optimizing trials and improve the integration of trials with care delivery – but technology alone will not fulfill the need for more clinical trial sites and better ways of working between sponsors and sites. Sponsors can deepen relationships with their existing site partners through several channels, including on-time payments, partnership-based CRA models, and centralized resources and trial documentation. Additionally, sponsors should look to build new partnerships with research-naïve sites through evolving site selection processes, reducing technological burden, and supporting recruitment.

This article was first published in Clinical Leader.