Strategic site management delivers faster enrolment and start-up times

A top ten pharmaceutical company needed clinical site support as it changed its pipeline to focus on complex oncology studies. Building strong relationships with the specialist clinical sites was critical to enabling fast enrolment of the subjects, that were essential to the successful progression of the studies. Our client selected ICON to support their transition into this challenging therapeutic area because of our focus on building long-term relationships with clinical sites to support recruitment initiatives and speed up study start-up timelines through our dedicated Site Engagement Liaison lead.
 

Clinical Research Associates (CRA) are usually tasked with managing the relationships with sites. However, this is just one of many tasks CRAs are responsible for, and site relationships often aren’t given the priority they should be.

With the shift into oncology, a new and more complex therapeutic focus for our client, came a need to develop strong relationships with new sites conducting the specialist studies. Our client’s experience was that they weren’t seeing enrolment of the right subjects and enrolment rates were not high enough to meetstudy timelines. Additionally, selecting patients who did not fit the study led to screen failure rates that further lengthened study timelines.

We knew we had to incorporate flexibility into our processes as our client undertook these changes to its pipeline and therapeutic focus. Moreover, we needed to have a thorough understanding of which patients would be the best fit based on inclusion/exclusion criteria - and to develop a strategy to attract those patients. Additionally, to ensure that clinical sites would want to partner with our client again in future studies, we needed to facilitate an easy and productive working relationship.

Our focus was on leading site relationships on behalf of our client through a strategically focused Site Engagement Liaison. This person was embedded into our client’s business, representing them with the sites and ensuring they fully understood the protocol and who we needed to recruit in detail. The Site Engagement Liaison monitored the recruitment across all sites and was able to share learnings from sites recruiting successfully with sites that were seeing challenges to ultimately improve delivery times. The Site Engagement Liaison became an integral part of the trial process by providing three-way communication between the client, CRA and clinical sites at all times. More importantly, they served as our client’s surrogate in building strong relationships with these sites, and in improving overall site engagement and performance.

Our Site Engagement Liaison offered the following support:

• Strategic site-specific subject enrolment plan 

Identification of barriers that impact multiple sites by conducting ongoing analysis and reporting, and by providing enrolment optimisation support. Before the study started enrolling, we pre-screened site’s databases for potential participants. Leveraging our experience in strategic planning and risk mitigation we created a plan that was tailored to each site’s potential, looking at specific recruitment processes and onboarding as well as recruitment and retention barriers, such as hesitancy and COVID-19 restrictions. Building relationships with the referring physicians in their network. This focus on finding the right patients for the study meant that we decreased screen failure rates and study timelines.

• Building long-term site relationships directly for our client

One of the greatest challenges to patient recruitment is when the study team don’t have time engaging with the site properly. Our Site Engagement Liaison acted as a single point of contact to connect all the clinical sites in the study. We integrate with our client to become an extension of their team. From there, we build a connection to sites by conducting site training and by streamlining communications. In addition to the clinical site, our team builds relationships within the surrounding community to improve access to patients.

• Employing a holistic view of enrolment insight

Our Site Engagement Liaison has oversight of enrolment on all sites and share insights between sites that are enrolling well and those that are moving slower. This strategic approach ensures faster enrolment and supports increased diversity in the subject population.

Through their flexibility and site-specific planning, our Site Engagement Liaisons have been able to speed up site activation timelines, shorten enrolment timelines, increase enrolment and subject retention, and improve overall site collaboration.

Our Site Engagement Liaisons have delivered a significant increase in enrolment and shortened study timelines for our client. While the study with this client is still ongoing,
we expect to deliver outcomes similar to the results of previous studies we have conducted for other clients, which, on average, have been the following: