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Evaluating Adaptive Trials: Do They Align with Your Study’s Goals and Requirements?

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Innovative clinical trial approaches, including adaptive study designs, can play a key role in improving the efficiency of new drug development within biotech and pharma clinical research. Adaptive trial designs, which allow for prespecified modifications to key trial parameters based on interim data (such as sample size, treatment arms, or endpoints), enable earlier decision-making and can reduce the overall time and cost of running clinical trials. Several factors have impacted the use of adaptive design clinical trials, including:

Complex Diseases

Adaptive trials can more efficiently test treatments for conditions with smaller patient populations or heterogeneous responses, such as oncology, neurological disorders, and autoimmune diseases.

Regulatory Innovations and Frameworks

Initiatives like the FDA’s Complex Innovative Trial Designs (CID) Pilot Program and the FDA Adaptive Design Guidance have encouraged sponsors to incorporate adaptive methodologies.

Risk Mitigation through Midcourse Corrections

Adaptive design trials allow for prespecified modifications during the course of the study based on the accrued evidence. Midcourse corrections, including increasing of sample size or targeting of the inclusion criteria in an enrichment design can reduce risk of inconclusive evidence observed from the trial.

Patient Safety

Adaptive trial designs can improve patient safety by minimizing exposure to unsafe or non-efficacious treatments.

Faster Timelines

Adaptive trials help shorten development timelines and accelerate decision-making by enabling early stopping for success or futility.

These factors have made adaptive trials a worthy consideration. However, adaptive trials are not for every clinical program. Careful evaluation is essential to determine if an adaptive approach aligns with your trial's specific goals, resources, and regulatory requirements.

Watch this short video as Robin Bliss, Vice President, Strategic Consulting at Veristat, shares four key questions that she likes to ask when planning an adaptive design clinical trial.

 

Would you like insight into determining whether an adaptive clinical trial is right for your program? Our experts can help. Contact us to arrange a call.

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