For the past 5 years, there has been a major concern about the rising cost of research and development within the pharmaceutical industry. Also, the significant reduction of new chemical entity into the market. To overcome with these issues, adaptive clinical trials are used in a high rate.
USFDA defines an adaptive design clinical study as a study that includes a prospectively planned opportunity for modification of one or more specified aspects of the study design and hypotheses based on analysis of data (usually interim data) from subjects in the study. Analyses of the accumulating study data are performed at prospectively planned timepoints within the study, can be performed in a fully blinded manner or in an unblinded manner, and can occur with or without formal statistical hypothesis testing.
Current Challenges in adaptive clinical trials:
To deliver compliant clinical trials supplies across different patient populations whereas the short time frames required by adaptive trial designs to ensure the product quality and patient compliance is not compromised. Sponsors use interim data analysis to constantly re-assess their methodology. This often results in considerable changes being made to the study as it advances. Modifications mostly comprise of making changes to the dosage level of a specific drug. To make sure about the efficient distribution of materials. For instance, compliant deliveries of investigational products to various study sites present a significant challenge. Hence, there is a need to make sure that Current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), and the revised Good Distribution Practice (GDP) guidelines are followed. Another critical part of this process is to make sure that the drug is tracked throughout the clinical trial life cycle.
Benefits of adaptive clinical trials:
This could save both costs and time by eliminating the number of study failures, if and only if the adaptive clinical trials are used appropriately. Clinical trials designed with adaptive features can potentially result in more efficient decision-making within a drug development program, and provide a greater chance of responding to the clinical question of interest. Also, since the design allows investigators to assess results on a real-time basis, changes can be easily made to enhance the probability of a positive result.
Adaptive clinical trial designs lead to enhanced product development processes and enable improved patient safety. However, in spite of their wide-ranging benefits there are potential pitfalls for every clinical trial. Therefore, potential risks should be taken into account when opting for a specific approach.