Rapid Accurate Modelling of Vaccine Studies

Introduction

The Covid-19 pandemic impacted the world and drove a tsunami of vaccine trials. At the peak of the pandemic there were over 80 coronavirus vaccines in trials and over 180 in pre-clinical studies. Speed was of the essence.

While Biopharmaceutical companies have improved their clinical trial processes and tools over the last 10 years, a critical component of the process has been largely ignored. Sponsors use of Excel for budgeting is burdensome and time-consuming. There is a heavy dependence on CRO budgets to determine costs and plans for these critical trials. With a goal of breaking this long cycle, the clinical outsourcing team of a biotechnology company, focused on infectious diseases, turned to Strategikon’s Clinical Maestro® platform to help them respond quickly and confidently. Clinical Maestro is a SaaS-based platform that digitizes business operations processes, provides an efficient, accurate alternative to Excel and reduces or eliminates reliance on CRO provided budgets. While designed for clinical trial budgeting and outsourcing processes, it has been specifically tuned for Vaccine studies.

The challenge

The biopharma company had done their research and had a clear plan with three primary objectives:

Create reliable vaccine study budget scenarios quickly
Perform side-by-side scenario analyses to efficiently identify impacts on study budget and timelines
Quickly access financial projections and spend curves for different study scenarios.

Comparing the biopharma’s specifications and Clinical Maestro assumption defaults was the first step in creating a baseline budget to be leveraged in CRO negotiations at the RFP level. One difference found: CROs define tasks differently resulting in variation in calculated study assumptions (ex. # of CRF pages, TFLG re-runs), impacting the direct labor cost. Alternatively, Clinical Maestro’s default assumptions are driven by study phase, protocol complexity, and normalized metrics providing a reliable specification set to be utilized in the proposal due diligence process. The platform standardizes bid grid and task structure simplifying comparisons across scenarios & CRO bids.

After the analysis, the biopharma and Strategikon determined that an “intensity” factor should modify the budget definition to account for specific therapeutic factors. This new factor is a combination of several components which determine a higher or less complex study.

This “intensity” factor reflected a number of unique elements of the vaccine operating model, which was centered on achieving speed, and had a significantly higher impact on cost than the complexity of the protocol. These elements include speed of enrollment in multiple countries for a large number of patients, high frequency of internal & Sponsor meetings, and rapid site activation timeline. Combined, the “intensity” resulted into a high allocation of resources in the study start-up and close-out space. This unique model required tweaking the cost model and fine-tuning assumptions to reflect the correct cost allocation and provided a strong foundation for CRO negotiations.

Results

Strategikon and the biopharma company worked closely together to develop a number of cost scenarios that reflected the protocol complexity, the operational intensity and the specifications of the study. As a result, the biopharma company created the most likely cost model that reflected the unique study needs. Upon completion of proposal due diligence, when comparing with the winning CRO bid the results were spot on, demonstrating the flexibility, accuracy and versatility of the Clinical Maestro PORTFOLIO™ as the industry’s most advanced cost modeling software solution for clinical trials.

Phase I variance was 0%
Phase II variance was 2.25%
Refinements to Clinical Maestro algorithms bring accuracy to +/-1.5%
Clinical Maestro can be fined tuned for other therapeutic areas.

Conclusion

The Pandemic highlighted the need for flexibility and granularity in study budgeting, especially around scenario planning of complex operating models, such as vaccine development. Beyond the vaccine study modeling, Clinical Maestro was used extensively during the Pandemic to develop “what if” scenarios that included changes of country mix and timelines which were essential for impact analyses on time and cost in support of critical decisions. The collaboration with the biopharma company further led to fine tuning the Clinical Maestro therapeutic area-specific cost models and demonstrated the importance of strategic collaboration in advancing planning accuracy and leveraging the intelligence in the CRO negotiations.