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Acknowledging eligibility’s inherent cost and complexity
The eligibility screening process is a critical step in the success of any trial, not only to enroll qualified subjects to ensure new drugs are safe and effective for patients but also to contain the overall cost of bringing promising new therapies to market. Finding the right trial participants is a significant financial burden for sponsors, costing between $129 and $336 per enrolled patient (or upwards of $90,000 annually) depending on the trial phase.¹ In addition, sponsors generally lack visibility into enrollment progress and topline insights that could streamline the process and help avoid costly mistakes. For example, if some sites are slow to hit their enrollment targets, the trial must be extended. As a result, that could cost sponsors millions of dollars per day, not to mention losses related to delayed revenue.
At a high level, eligibility involves diligent data collection and stringent process control to enroll the right subjects and ensure trial viability. This endeavor also requires a thorough knowledge of compliance protocols, clinical expertise and detailed project management. Together, these capabilities make it possible for sponsors to meet the precise criteria established for clinical trials that are backed by huge investments in research, time and other resources.
The promise of digital to improve efficiencies
Cloud-based platforms are potential game-changers for eligibility screening. They can streamline the collection of detailed eligibility data from all over the world in one location, so authorized stakeholders can make an informed decision. This is accomplished by leveraging modern technologies like artificial intelligence (AI) to automate complex and custom workflow configurations. Technology can transform arduous, error-prone processes into something akin to TurboTax, guiding users through standardized steps and remedying issues as they arise to ensure enrollment success.
In addition to streamlined data collection, sponsors have long desired integrated data quality tools and the ability to see in real-time how many trial subjects are eligible for a trial. This transparency virtually eliminates the need for sponsors to fly monitors to individual sites to inspect the quality and accuracy of eligibility information and ensures the right subjects are selected to help guarantee trial viability. This is important considering sponsors dedicate an average of 25% of their budget to source data verification.2
Regulatory compliance is also improved with a more modern, tech-enabled approach. Instead of toggling between disparate systems to cobble together an eligibility audit trail, cloud-based platforms offer a single source of truth with a clear view of the specific data that informed an eligibility decision. For example, traditional approaches provide no easy way to trace a specific lab value that determines a patient’s eligibility to participate in a trial. This information is valuable, particularly if enrollment protocols are revisited at any point, or past medical decisions need to be reviewed.
Conclusion
Centralized data management and automated workflows reduce the number of failure points inherent in existing, manual eligibility processes. The more personnel, systems, amendments, and moving parts, the greater the chance a clinical trial will be delayed or risk non-compliance. Increased technology adoption can help manage the first, crucial step of determining participant eligibility and set an organized, traceable, and fully transparent clinical trial in motion with the right participants.
There is a lot at stake as globally distributed trials are backed by years of research and tens of millions of dollars. Scientifically viable protocols, digital source data verification, transparency, and easy access to decision rationale will inform and assure all stakeholders while reducing costs and increasing efficiency and regulatory compliance. With the move to digital, sponsors will finally be equipped to spot potential issues early, pivot as needed, and accelerate time to enrollment targets with confidence.
Resources
- Effort Required in Eligibility Screening for Clinical Trials. Lynne T. Penberthy, Bassam A. Dahman, Valentina I. Petkov, and Jonathan P. DeShazo. Journal of Oncology Practice 2012 8:6, 365-370.
- Impact of source data verification on data quality in clinical trials: an empirical post hoc analysis of three phase 3 randomized clinical trials. Andersen JR, Byrjalsen I, Bihlet A, et al. Br J Clin Pharmacol. 2015;79(4):660-668. doi:10.1111/bcp.12531
Judith Narisi
Judy Narisi, RN, BSN, is the senior director, adjudication services and specialty solutions at Clario, leading the project management and operational teams to ensure that each client benefits from knowledgeable and experienced adjudication team support. Trained as a critical care RN, Judy began her research career in 2004 as a study coordinator moving into safety event case management and then event adjudication in 2006. Since then, she has successfully managed a team that has been effective in rescuing several large programs and contributed to the approval of several pharmaceutical drugs supported by the adjudication of thousands of events. Judy received her nursing degree from Gwynedd Mercy University in Pennsylvania.
Filed Under: clinical trials, Drug Discovery
