Adaptive Clinical Trial Design
An approach to clinical trials popularized in the mid 1990’s, Adaptive-By- Design allows for adjustments and modifications during the clinical trial, making the study responsive in real-time. Increasingly popular, Adaptive design helps sponsors determine if the therapy is going to fail, and if so, to help it fail early, shortening timelines and reducing costs. Adaptive trials help expedite and improve efficiencies for identifying the clinical benefit of new therapies.
Compared to typical clinical trial designs, adaptive clinical trial designs are more complex. They require more detailed planning, experience, more interaction with regulatory authorities and require trial simulations prior to clinical study start-up. Statisticians can take existing or historic trial data for a particular disease area and create hypothetical scenarios that can inform the shaping of a tighter, better designed trial. Good planning hones each aspect of a trial making it responsive, integrative of candidate data, and improves return on investment.
Good design = Good data.
So, how do we launch a trial that is good by design? By making it adaptive.
What Makes a Clinical Trial Adaptive?
To cite a BMJ article, BMJ 2018;360:k698, what makes a clinical trial adaptive is:
- Key study design components can be adapted throughout the trial
- Trial planning involves several rounds of simulations
- Consequences and gains of possible trial adaptations need to be understood before initiation
- Statistical analysis plans are needed for both interim and final analyses
- Research question may change along with adaptations (for example, narrowing the population)
- Multiple trials (such as phase II and III) can seamlessly be combined in one adaptive trial
- New experimental treatments can be added rather than starting a new separate trial
Benefits of Adaptive Clinical Trial Designs
Although adaptive designs are more complex, investing in them can offer many potential benefits including:
- increasing the trial’s probability of success
- Faster “go/no-go” decisions
- reducing the overall time and cost of the trial
- reduced required resources
- Better dosing and frequency decisions
- Reduces time to market
- increase efficiencies
- delivering the right drug to the right patients, improving patient safety
- whether to stop a trial for ineffective or unsafe drugs more quickly
Our Adaptive Clinical Trial Design Process
McDougall Scientific’s over 35 years of experience will help you with strategic planning, design, simulation, implementation and analysis of your adaptive design specific to your research goals.
McDougall Scientific works across all phases of drug development and all therapeutic areas. Our experts are industry leaders with extensive knowledge of design, statistical methodology and regulatory requirements and offer a wide selection of services committed to the success of your goals.
Are McDougall Scientific’s services a good fit for your needs? Contact us to start a discussion around your requirements.