From my time working at 3M and most recently at Kinevant Sciences, I wanted to share my perspective of a concept that improves overall financial forecasting of manufacturing and executing clinical trials. Time can be the most material variable of a clinical trial budget. The learning curve is a concept that should be incorporated into operational and financial forecast models. Incorporating the impact the learning curve has on operational activities from the initial RFP will contribute to improved financial accuracy and minimize variances to budget.
The Learning Curve.
Even the best manufacturing organizations in the world like 3M will have a learning curve when producing a new product. It takes a few iterations to work through issues and minimize the time it takes to produce the same product. Similarly with clinical trials, activities across a multitude of sites will experience a learning curve. While the first couple of site activations might be cumbersome, after a few successful activations the clinical team / CRO will be able to proactively address common issues experienced and reduce the time to activate a site.
The learning curve has a direct impact on the financials because the rate at which sites are activated is not linear. Having a clinical trial financial forecast that accounts for a learning curve could be beneficial in two ways.
- Minimize variances to budget with increased accuracy of site activation variable expenditures.
- Critically evaluate the quality of study startup timelines provided by CRO’s during the RFP process.
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