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Adaptive Design for Clinical Trials

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

Adaptive design clinical trials are encouraged by the FDA to expedite and improve efficiencies for identifying the clinical benefit of new therapies. Compared to traditional clinical trial designs, adaptive clinical trial designs are more complex and therefore require careful consideration, rigorous planning, and trial simulations prior to 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.

Veristat will provide you with the expertise in 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 then to communicate and execute the study with the investigational sites and overall project team. This is where Veristat can help you. 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

Adaptive 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.

Types of Adaptive Clinical Trial Designs
Adaptive Dose-Escalation Design (ADED)	Adaptive Dose Finding
Adaptive Randomization Design	Dropping Treatment Arm (or Pick the Winner Design)
Group Sequential Design (GSD)	Population Enrichment Design
Sample Size Re-Estimation (SSR)	Seamless Phase I/II or II/III Design

Benefits of Adaptive Clinical Trial Designs

Reduces cost, time & required resources
Increases the chance of a successful study via midcourse corrections
Reduces time to market
Mitigates risks
Improves patient safety
Facilitates better decision-making

Considerations for Adaptive Clinical Trial Designs

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

When to Consider Adaptive Designs

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: