The Cost-Benefit Analysis of Engaging Statistical Experts
Incorporating a statistical expert into a product development team is a strategic investment that brings immense value. It is not merely an expenditure, but rather a cost-benefit dynamic where biostatisticians’ expertise is pivotal. They bring knowledge that enhances efficiency and reduces the risk of expensive pitfalls and unforeseen delays in clinical trials.
Statistical experts can navigate complex trial data and expedite the development timeline, directly correlating to resource allocation and optimizing time and financial investments. By engaging such expertise, potential issues can be identified and rectified before they manifest into costly obstacles.
“A good statistician should make your process smarter and more complete.”
Essentially, according to CEO of Stat One, George DeMuth, a good statistician “should make your process smarter and more complete”. He continues, “What is not a good idea is waiting till after FDA pre-sub meetings to call in the statistician. In our experience at Stat One, most statistical issues raised by the FDA in these situations, we would have anticipated. Hence, you can end up losing part of the value of a pre-sub meeting from the get-go.”
Mr. DeMuth advises that early engagement with an experienced statistical group can be beneficial for the following reasons:
- The statistician can assist in your development by providing input on 1) study design, 2) sample size, and 3) best analysis practices.
- They can ensure statistical text of programs and synopses are accurate.
- They can help alert you to specific considerations:
- Choice of the best endpoint and associated analysis
- Strategies or approaches to mitigate the impact of missing data
- Strategies to address multiplicity of analysis issues
- Adaptive or interim design options
This proactive approach to trial management ensures a more navigable course through the unpredictable waters in product development, where every decision holds significant financial implications. The expert understanding and application of statistical principles by biostatisticians are not just beneficial but also cost-effective and financially strategic.
Integrating statistical insight into product development offers a compelling narrative of cost savings and resource optimization while aiming for meaningful and impactful medical advancements. With a focus on both data quality and expert statistics, Stat One proves to be an exceptional collaborator for leading your clinical programs to successful FDA approval and post-market strategy.
