The pharmaceutical industry has always been challenged by the uncertainties of clinical trial recruitment, but the COVID pandemic further complicated matters. The recruitment and retention of clinical trial subjects became even more challenging, causing delays and profound downstream impacts. Captario SUM®, the pharmaceutical portfolio management platform, conducted a case study in 2020 to demonstrate the impact of COVID-related delays on portfolio value over time, highlighting the importance of the order of entry and sales for pharmaceutical companies.
Captario’s client was developing a biomarker-driven asset for refractory patients with a rare, orphan disease. Since there were no targeted therapies for this specific indication, the overall opportunity for launching a pharmaceutical was modest. However, the development landscape for this unmet disease remained highly competitive, with a potential competitor targeting a similar patient population on track to launch during 2024. The client faced challenges in recruiting patients for their pivotal trial, leading to uncertainty about their launch window and decreasing confidence as the pandemic progressed. The key question posed to Captario was: “What will the monthly recruitment rate need to be so that we are first to market?"
Captario used its portfolio management platform, Captario SUM®, to construct a model that mirrored the clinical development plan for this asset, including key studies, decision points, and underlying assumptions. Using an expression for the primary driver of time to market, trial duration, Captario was able to make trial duration dependent on both the number of clinical trial study centers and their monthly patient recruitment rates. This allowed the client to directly observe the impact of patient recruitment rate on launch timing and ultimately order of entry.
In collaboration with the client, Captario introduced a commercial sales forecast into the model. This enabled them to directly observe the impact of recruitment rate on market share and consequently sales and net present value (NPV). Captario found that if the client maintained their current recruitment rate, the probability of being first to market was very low. To have a shot at being first to market, the client would need to significantly increase monthly recruitment, which would require additional coordination and expense. The near-term recruitment cost expenses would be substantially outweighed by downstream sales if they can beat their competition to market.
In conclusion, clinical trial recruitment for pharmaceutical companies is always a difficult endeavor, and the COVID pandemic exacerbated this challenge. Captario’s portfolio management platform provided modeling, simulation, and visualization capabilities that enabled the client to quickly and easily identify the recruitment rate required to be first to market in a competitive marketplace.