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Forecasting Resources for Clinical Trials: An Art or a Science?

Project planners operate in a world of constant change and need tools that will enable them to quickly revise forecast scenarios that reflect the present and future research and development (R & D) environment. The resource calculation model presented here provides the project planner with a relatively easy method to calculate and revise clinical grant expenditures, and personnel and operational cost requirements for: 1. ongoing projects, 2. compounds in the R&D pipeline, and 3. future unknown compounds that are anticipated either from discovery or joint ventures with other firms. A portfolio of resources is constructed and forecasted out 8-10 years that can be revised to create various resource requirement scenarios for R&D strategic planning. To check the validity of the model, three projects that were selected for contracting out to contract research organizations (CROs) were costed out in the model and then compared to the pricing submitted in CRO bids. In each case, the estimates from the model were within 20% of the totals submitted in the CRO bids. The main issue, however, is not so much whether doing work in-house is cheaper than using CROs, but that one must be sure to include all costs, both obvious and “hidden,” and whether or not the resource calculation model presented here can be an effective tool for both sponsors and CROs.