Investigator-Initiated Trials Didn’t Bounce Back After COVID-19, What Can We Do About It?

By Kristin Surdam, Sr. Director, KOL & Strategy @ Florence Healthcare

Having worked in the clinical research industry for 15+ years, I’ve seen a lot of obstacles come our way in the effective operations of clinical trials. Most recently, the Great Resignation has impacted our capacity as an industry, though investigator-initiated and grant-funded trials seem to have been hit the hardest. 

Investigator-initiated trials are critical for translational medicine and often bring bench science into the clinic to provide new therapies to patients. Challenges in the industry have always been plentiful, but I have also seen us assess, adapt, and overcome obstacles for the betterment of our industry. Those experiences are what spur confidence in our ability to find solutions to this challenge.

According to a recent NCI survey of 64 Cancer Centers, investigator-initiated trials (IITs) in particular have failed to make a comeback post-pandemic. Accrual rates for IITs are lingering at a 20-25% deficit in enrollment for the last three years, due in part to a sparse workforce. Some sites surveyed have lost upwards of 50% of their clinical trial staff to higher-paying or more flexible, remote positions, which has further tightened the capacity gap at these institutions. A significant percentage of those departing transitioned into roles at pharma and CRO companies, which typically offer remote work and higher pay.

Despite the pressures of a widening capacity gap throughout 2022, academic medical centers have an opportunity to seize innovative solutions that can begin to close the gap. Improving operational efficiency allows site staff to focus on patient activities, such as enrollment into investigator-initiated and grant-funded trials.

Strategies Sites Can Harness to Increase IIT Capacity and Effectiveness

One way to improve operational efficiency is to rethink staffing strategies, which can boost investigator-initiated trial performance by proxy. This may include automating redundant or manual tasks and identifying work packages that can be delegated to lower-level resources. 

Taking advantage of open APIs for successful integrations, implementing new site tech to streamline study operations, and investing in patient engagement platforms can all help reduce administrative burdens, resulting in more time for coordinators to focus on patient recruitment and visits.

In addition to these steps, academic medical centers could also consider increasing their partnerships with other institutions. engaging in partnerships with other institutions could lead to a sharing of resources and knowledge that can further accelerate trial recruitment and completion.

The Sponsor and CRO Role in Helping Sites with IITs

Sponsors and CROs can also play a crucial role in supporting IITs. As financial investors in many investigator-initiated trials, sponsors often provide investigational products and use IIT study results to support New Drug Applications. Most academic institutions running investigator-initiated trials also run industry-sponsored trials. 

When sponsors and CROs invest in quality site enablement tools for their sites, capacity is organically grown and sponsors and CROs indirectly affect the progress of IITs and grant-funded trials. Through the provision of site-centric tech, streamlined workflows can reduce or eliminate redundancy while allowing sponsor-investigators to drive up enrollment efforts on their own trials.

The Vendor’s Role in Supporting Sites with IITs

It’s also important for vendors to understand the financial constraints most IITs operate under and work collaboratively with institutions to support crucial grant funded studies. Vendors of all types can find creative ways to help sites overcome traditional challenges facing investigator-initiated trials.

While a vendor’s approach may differ based on the type of service or product offered, Florence elevates IIT operations by offering complimentary access to our platform for those studies, ensuring that customers can provide their investigators managing an IIT the same level of software that industry funded studies generally receive.

Collaboration and the Future of IITs

One of the most important things that academic medical centers, sponsors, and CROs can do is to create a culture of teamwork and collaboration. By working together, we can overcome the challenges that the Great Resignation has presented to the clinical trial industry. Collaboration across stakeholders can include sharing best practices, working together to address common challenges, and creating new approaches to patient recruitment and engagement.

It is clear that if all stakeholders in clinical research work collaboratively to find innovative solutions, we can ensure the ongoing success of clinical trials and accelerate the delivery of cutting-edge therapies to patients.

About Kristin Surdam

Kristin is a clinical research professional with more than 15 years of experience in phase I – IV multi-center clinical trials, at both the site and sponsor levels. Kristin has earned industry certifications as both a Certified Clinical Research Coordinator and a Project Management Professional, demonstrating her proficiency and commitment to the industry.  In addition, Kristin holds a Master of Science in Leadership and serves as a Key Opinion Leader and Subject Matter Expert at Florence Healthcare, working to drive forward clinical research technology, streamline study operations, and ultimately condense the time to market for new therapies.

About Florence Healthcare

Florence’s Site Enablement Platform provides site-centric automated and integrated workflow technology that connects sites, sponsors, and CROs for every step of a clinical trial. Florence powers over 5.5 million research workflows every month across more than 12,000 sites in 45 countries, advancing cures and accelerating research. Its SiteLink solution is deployed by 3 of the top 5 pharma and CRO companies to the sites in their studies to enable remote start-up, monitoring and site management capabilities.