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Quantifying Tradeoffs in Clinical Development

One of the most difficult challenges facing Research and Development teams involves determining how to make tradeoffs between the speed, savings and success of a clinical trial. While some sponsors have to forego improved power in order to remain within strict resource limits, others sometimes increase their clinical development budget to accommodate unexpected gains in statistical power.

Complicating the picture is the fact that different members of an R&D team might have differing values that they place on speed, savings and success. While all three of these parameters affect the expected revenue from a trial (sometimes called the expected net present value or eNPV), we often find some members of the R&D team more concerned about completion dates, and others about investments in clinical operations, and so forth.

Given an element of subjectivity in determining the relevant value of speed, savings and success, Cytel’s statistical consultants suggest devising a quantitative scoring rule by which to rank different trial designs. This feature of Cytel’s Advanced Design Framework helps teams determine how much weight they place on each of the three parameters – speed, savings, probability of success – and then ranks orders trial designs in accordance with the score.

Once the scoring rule is in place, Cytel’s Solara software can then quickly run simulations over thousands of designs, and rank them in accordance with their score so that clinical development teams can quickly spot those that best reflect the needs of the sponsor.

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