Designing a trial to meet the minimum FDA requirements is not sufficient to ensure product success. Health Advances combines an understanding of regulatory requirements and processes with a critical market perspective to formulate a practical, robust clinical strategy that will change the treatment paradigm and drive adoption. Major elements of our clinical trial strategy and benchmarking practice include:
- Documenting clinical and scientific benchmarks of product performance and supporting data for competitors and recent product filings in the related area(s).
- Identifying new or proposed regulatory guidelines or rulings that will impact expectations for future trials.
- Identifying the key users and/or purchases of the product and understanding how they will evaluate the new product, including the level of performance along several dimensions such as safety, efficacy, ease of use, etc., that will be required to move them to change current practices.
- Evaluating various trial design options and prioritizing the options by comparing the likely duration and cost of each, as well as the probability of success given available product and market information and the likelihood that the results, if successful, will be sufficient to gain adoption and to what degree penetration is likely to occur with various claims possibilities.
Health Advances is focused on helping our clients determine the optimal clinical trial strategy and is not biased in any way by the implications for follow-up trial management work, since we are not a CRO. If a small and fast trial is the best first step in the overall development strategy, then that will be the recommendation.
View our Clinical Development Strategy case examples.
See an example of a client case on clinical development strategy for inflammatory bowel disease.