As both the complexity and cost of clinical research have expanded in recent years, the benefits of a structured and inflexible clinical trial design have diminished. Increasingly, sponsors are incorporating elements of adaptive design in clinical research, allowing researchers to analyze data mid-stream and then use that information to refine research strategy and modify trial design as necessary without compromising the scientific integrity of the trial. This approach, while more complex, can work to keep a clinical research effort on track while having a potentially positive impact on factors including cost, patient safety or trial duration.
The use of adaptive design in clinical research programs requires an enhanced focus on many critical elements including clinical monitoring, statistical analysis, regulatory compliance and investigator education and support. With extensive experience in the planning and execution of clinical trials incorporating adaptive design elements, PROMETRIKA is able to help sponsors access the benefits of this option while minimizing risk. We provide the statistical knowledge and expertise necessary to evaluate data from ongoing studies. Our evaluations provide the insights necessary to make important decisions related to stopping a study based on outstanding efficacy or futility, sample size re-estimation, and outcome-adaptive randomization. We can also coordinate services as necessary under the auspices of an IDMC.