We are all painfully aware of the time and money required to move a therapeutic into the marketplace: the only promises are that it will be long and expensive. Adaptive clinical trials: a systematic examination of data to allow interim adjustments in the study design, can efficiently streamline the process.
Among many good reasons to consider the use of adaptive trials, a number of advantages stand out:
• Ability to identify faulty design assumptions;
• Power to test multiple study approaches;
• Malleability to allow the addition of emergent data;
• Flexibility to react to unexpected findings;
• Most importantly, the collective power to shorten development time.
Further, there are a variety of scenarios when inadequate information exists at the time that the protocol is designed, necessitating an adaptive approach. Examples include the following:
• Unknown dose-response effect;
• Unclear event rates;
• Unidentified discontinuation rates;
• Indefinite population variances;
• Uncharacterized special populations.
The use of adaptive clinical trials, though, introduces many new complexities to clinical research. Thus, the successful planning, execution and analyses of these novel studies depends on the availability of a robust, fully integrated suite of software. Key disciplines that are required would include:
• Data management (including EDC);
• Clinical trial management;
• Adverse event coding;
• Report generation;
• Statistical consultation.
DZS is proud to couple their top notch clinical research capabilities with their proprietary ClinPlus® suite of clinical management software. This powerful combination of experience and technology is potently engineered to optimize drug development, fully supporting the consistent delivery of solid, reliable data, obtained using adaptive clinical studies.