Introduction
Medical science is rapidly advancing, bringing with it increasing complexities in clinical research. In the last 15 years, we’ve witnessed an 86% increase in total data endpoints per trial. Nearly 40% of trials will enroll fewer patients than necessary, and in some cases, enrolling only a single patient. These sites are the most costly because they have technically been activated and require ongoing performance monitoring, data collection, and supplies. These challenges not only delay timelines to bring innovative therapies to market, but also delays payment for clinical trial sites, who are equally burdened with fixed operational costs. Thus, many sites are left to operate in the red.
Why do clinical trials commonly operate in the red?
The status quo in clinical development is that pharmaceutical companies sponsor clinical trials, meaning they pay for and ultimately take full responsibility of ensuring that the trials are conducted according to regulation. Some companies have the development infrastructure to manage all of the regulatory, data management, and safety reporting responsibilities, and work directly with clinical research sites that treat patients with an investigational drug. Other sponsors will contract with a contract research organization (CRO) to perform these duties. In either scenario, budgets are commonly negotiated on a “pay for performance” basis, where sites are paid on a per patient or per event basis.
Increasing complexity
Despite sites’ business acumen and ability to manage financial data and trial portfolios, there are persistent challenges with patient allotment and enrollment. This creates a detrimental feedback loop that worsens the issue. Small changes in strategy, intended to minimize the risk of under-enrollment, result in magnified effects that further accentuate trial complications. Sponsors are opting for therapeutic areas and drug classes that have the highest potential to make it to market. This means sites must navigate increasingly complex criteria, for which there are fewer eligible participants. Consequently, sites direct more resources to identifying participants, squeezing their already-tight margins for operations.
Another strategy that sponsors have adopted intending to de-risk enrollment is inflating the number of trial sites, while limiting the number of participants allotted to each site. This further compounds the resource strain for sites, which have fixed operating costs. This cycle not only strains site operations, but is also a catch twenty-two for sponsors, making it harder to conduct trials efficiently.
Pressure to get trials moving
Preparation is another pressing issue for clinical research teams. Because of the pressure to get trials moving, driven by the need to stay competitive, there has been an uptick in the number of unprepared study teams. Historically, about 20% of trials faced sponsor-driven delays, but this figure has increased dramatically, reaching 35-40% in 2021 and surging to 60% in 2022. This pressure to get started and show impact paradoxically increases the risk of starting trials without fully resolving potential bottlenecks, resulting in greater uncertainty and more protocol amendments required throughout the duration of the trial. These issues not only disrupt the trial process, but also inflate the overall cost.
Limited insight into real-world data
This is, in part, due to the fact that sites typically do have access to RWD required to assess trial feasibility (i.e., having an adequate number of patients within the site’s patient population that meet the eligibility criteria of a given trial). The capability of accurately identifying eligible patients prior to study startup is potentially transformative — with implications for next-generation clinical trial design, site selection, participant allotment, contracting, budgets, and negotiations, as well as site performance and payment.
Current challenges for clinical trial sites
- When negotiating participant allotment with sponsors, research sites often estimate the number of eligible participants within the healthcare system(s) they serve, without access to RWD or the chance to align with healthcare administrators on the unmet medical needs in their community. This compromises their ability to not only negotiate reasonable performance metrics and payment terms, but also limits impact on improving health outcomes.
- Sites have limited insight into eligible patients, which hinders their ability to smartly select trials that meet their strategic and financial objectives, including the selection of therapies that meet their patient populations’ needs. Better selections would yield better outcomes, increased cash flow and an improvement in their bottom line.
- Inadequate insights coupled with outdated, manual processes for identifying eligible patients, results in inefficient use of researchers’ efforts, high staff-turnover, and ultimately, delayed market entry for new therapies. These inefficiencies put pressure on clinical development teams and investigators.
The Clint platform as a solution
The Clint platform taps electronic health record (EHR) systems to automate trial feasibility assessment and patient identification. This capability enables sites to identify trial-eligible patients for data-driven trial selection and contracting, align trials with unmet medical need in the healthcare system(s) they serve, and ultimately provides more flexibility for research teams to allocate staff effort toward more critical, participant-facing operations, and ultimately scale their operations. Clint sets a new standard in clinical trials, ensuring that all trials are data-driven, timely, cost-effective, and impactful.
"We are looking across millions of patients, understanding their unmet medical needs, and looking across the drug development pipeline to match the patients to companies researching cutting-edge treatments.”
- Dr. Rajesh Dash, Stanford cardiologist, researcher, and Founder of Clint
Success story
A large cardiovascular trial leveraged the Clint platform to query over 11,000 patient records, identifying 939 eligible candidates and an additional 920 high-yield prospects. This precision allowed the research team to meet their enrollment goals 4.5x faster and save $48,000 in operational costs.
Conclusion
Many clinical trials operate in the red due to increasing protocol complexity, changing strategies for participant allotment, increasing pressure to compete, and a fragmented data infrastructure. There is significant potential for technological advancements, such as the Clint platform, to improve the financial health of clinical trials and operational effectiveness of research sites.
Authored by
Cassandra Broadwin, MPH, Jasmine LaCoursiere, MS, Malcolm Bohm, Rajesh Dash, MD
