Why Clinical Trial Sites Are One of Endo’s Most Important Partners
Many people play important roles in the journey to bringing a medicine to market. One of the most critical players is the clinical trial site itself. This can be a large healthcare institution, a community hospital, or an independent doctor’s office.
In all instances, the teams who run the clinical trial—including recruiting the patients, providing treatment, and gathering the data—are often the unsung heroes of the process, and they provide the very foundation of the critical research and data necessary for all research.
Despite their significance, clinical trial sites face challenges that compromise their ability or desire to run trials.
Issue 1: Staffing
Under-staffing is a significant issue that has made headlines since the Covid-19 pandemic, but the issue began well before 2020.
“Nationwide, for every experienced clinical research coordinator seeking work, there are 7 jobs posted,” reported a Clinical Trials article titled “Now is the time to fix the clinical research workforce crisis.” It went on to state, “For clinical research nurses, the ratio is 1:10.”1. And the authors assert that the demand is expected to increase.
In addition to the supply–demand imbalance, staff members are expected to do even more, contributing to overworking and burnout. And while the industry strives to reduce complexity, the unfortunate reality is that protocols are becoming more and more complicated. For instance, the number of substantive amendments has significantly increased due to sponsors (the company responsible for the clinical trial) adjusting the eligibility criteria because of enrollment challenges. The amendments may lead to operational disruptions, such as adjusting processes and updating documentation, which can be very labor-intensive and time-consuming.
Issue 2: Technology
Sites also must remain fluent in the newest tools and technology that have become inherent to executing trials. And often, sponsors like Endo expect sites to adopt new technology to streamline trial logistics, compile data, and align with sponsor requirements.
Anyone who works with a computer or other technology knows how disruptive new applications can be, even if they’re an upgrade from the previous way of doing things. There’s the training, onboarding, and aligning with other daily systems and processes. And again, this additional burden is often uncompensated.
Issue 3: Money
As Rosalie Filling, Vice President & Senior Global Head of R&D Operations at Endo, said in a keynote address for the Innovation Network, “Who here works for free? Who here gets paid every quarter?”
What sounds unreasonable to most of us is standard for clinical sites. Typical ways of doing business often dictate quarterly payments for clinical trial sites, meaning that sites have to front their expenses for the trial including resource payment of their own accounts before receiving payment from the sponsor. And as mentioned above, sites are expected to do more and more without pay.
Endo’s Approach to Clinical Site Partnership
Endo understands the importance of clinical sites, as well as the burdens that trials can put on their operations. We make it a priority to engage sites in a more collaborative way and work together as true partners.
Our Clinical Operations Team, inclusive of a dedicated Site Relationship Manager, guides this process, building meaningful relationships with sites and helping to address issues and needs. Through this effort, we identified several ways to support the sites and become a partner of choice for these clinical experts.
Perhaps the most basic: timely payments. More specifically, the frequency of it and the identification of what deserves compensation. The typical practice of quarterly payments for clinical sites is unnecessarily burdensome. Like all businesses, they need consistent income to manage staff, projects, and other operations. Endo provides monthly payments so that sites can effectively run their businesses while working with us on a trial. Moreover, we are open to discussions to ensure that sites are appropriately compensated for the work that they do.
We also invited clinical trial site operations staff, such as study coordinators and site directors, to participate in a Site Operations Feedback Advisory Board—which is not standard industry practice for a mid-size pharmaceutical company. Through the advisory board, these representatives provided us with, including, but not limited to, additional insights and feedback on the operational aspects of a study including technology we are employing, vendors, data processing, and communication. This allows us to continue to live our value of innovation and re-invent how we work.
Across the globe, our scientists, physicians, nurses, regulatory experts, statisticians, data managers, medical writers, and clinical operations staff work together to deliver Endo’s R&D programs in medical therapeutics, sterile injectables, and high-value generics. We could not deliver these programs without our clinical trial sites; we appreciate and value the important work they do every day to help us innovate the service of patient health and help everyone live their best life.
Watch Rosalie Filling’s keynote address at The Gathering from the Innovation Network:
1. Freel SA, Snyder DC, Bastarache K, et al. Now is the time to fix the clinical research workforce crisis. Clinical Trials. 2023;20(5):457-462. doi:10.1177/17407745231177885
