Adaptive Design Clinical Trials

Accelerate Clinical Development Success with Proven Expertise for Adaptive Clinical Trial Design, Simulation, and Execution

Adaptive design clinical trials are encouraged by Regulatory Agencies, including FDA, to expedite and improve efficiencies for identifying the clinical benefit of new therapies. Adaptive clinical trial designs are more complex than traditional clinical trial designs and therefore, require careful consideration, rigorous planning, and trial simulations before clinical study start-up. But, adaptive designs offer many potential benefits, such as increasing the trial's probability of success, reducing the overall time and cost of the trial, and delivering the right drug to the right patients.

Considering an adaptive design for your next clinical trial?

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Adaptive Design Clinical Trials - Defined

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Cross-functional expertise is required for the strategic planning, design, optimization, and implementation of your adaptive design. To embark on an adaptive design trial requires the ability to plan and communicate the design to the regulatory agencies and then to communicate and execute the study with the investigational sites and overall project team. Our experts will:

Utilize trial simulations to recommend various adaptive design options according to the disease area and company portfolio
Develop the adaptive design protocol and outline the strategy for working with regulatory authorities
Execute the adaptive design including trial monitoring, interim analysis, and suggesting necessary adaptations
Provide analysis and interpretation of the adaptive trial data
Manage the independent data monitoring committee (iDMC) activities

Benefits of Adaptive Design Clinical Trials

Reduces cost, time, and required resources - reducing time to market
Increases the chance study success via midcourse corrections
Mitigates risks by improving patient safety
Facilitates better decision-making

Considerations

Requires more intensive planning
Commands more frequent interaction with regulatory agencies
Improper execution can introduce bias
Confounding can result from adaptations
Certain adaptive designs may require larger sample sizes
Statistical significance (alpha) penalties apply

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Planning, Simulating, and Implementing Both Simple and Complex Adaptive Design Clinical Trials

Simple Adaptive Design Types

› Group-Sequential Design (GSD)
› Sample Size Re-Estimation (SSR)
› Adaptive Dose-Escalation Design (ADED)

Complex Adaptive Design Types

› Adaptive Dose-Finding
› Adaptive Randomization Design
› Dropping Treatment Arm
(or Pick-the-Winner Design)
› Seamless Phase I/II or II/III Design
› Population Enrichment Design
(aka adaptive enrichment, biomarker-driven design)

Planning Adaptive Design Clinical Trials

Expertise from start to finish

PLAN

Establish adaptive trial goals and outline the strategy for working with regulatory authorities

DESIGN

Develop the adaptive design methodology and design the protocol accordingly

SIMULATE

Utilize trial simulations to recommend various adaptive design options according to the disease area and company portfolio

IMPLEMENT

Execute the adaptive design trial - inclusive of trial monitoring, interim analysis, and making necessary adaptations. Provide final analysis and interpretation of the trial data.

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When to Consider Adaptive Designs for Clinical Trials

While adaptive designs can be advantageous in certain circumstances, they are not suited for every clinical trial. Adaptive designs are highly encouraged for clinical trials in the following applications: