Recently, there has been rise in the attrition rate in clinical research since drug development is an expensive and time-consuming process. Adaptive design clinical trial is a new concept, the regulatory agencies and industry has shown positive approach to this concept. It is a study that has opportunity for modification in the study hypothesis or design based on interim data collected from the participants of the study.
Types of Adaptive Research
The types of adaptive design in clinical trials include an a group sequential design, adaptive randomization design, a drop-the-loser design, a sample size re-estimation design, a biomarker-adaptive design, an adaptive dose finding design, an adaptive treatment-switching design, an adaptive seamless phase II/III trial design, a hypothesis-adaptive design, and a
multiple adaptive design.
Image 1: Types of adaptive clinical trial are represented.
Importance of adaptive research
Adaptive research trial is a method that promotes pre-specified modifications in the statistical procedures or design of an ongoing trial based on the data collected from the trial. The adaptive design trials boost clinical research by reducing the time factor and expenditure. Innovative and improved testing methods are drafted to bridge the gap between medical product development and basic scientific research. This in turn improves discovery, development and marketing of novel drugs. The adaptive design clinical research makes trials more flexible, fast and efficient. The investigators in adaptive clinical trial have the flexibility to identify the clinical benefit of the treatment under study while maintaining the integrity and validity of the intended study.
The adaptations and modification are pre-planned and based on data or information collected from the study.The accumulated study data is analysed at pre-planned intervals in the study and adaptation or changes are incorporated in the trial design or statistical procedure. Trial procedures include study dose, treatment duration, eligibility criteria, study endpoints, diagnostic procedures, laboratory tests, criteria for assessing and evaluating clinical responses. Statistical procedures are study design, study hypotheses, process of randomization, sample size, data monitoring, interim analysis, statistical plan and methods for data analysis.
Image 2: The adaptive clinical trial is pictorially described with an example.
Adaptive designs lack uniformity and require more computer-based simulations in clinical trials to develop the protocol and design. The data monitoring committee have to meet regularly to implement the changes and adaptations. Constant updating and reliable electronic data collection system is essential for such trials. Draft guidelines have been generated to meet regulatory requirements in adaptive design clinical trials. There is no need to file for protocol amendments since potential modifications are approved previously by the ethics committees and regulatory authorities which is an added advantage of adaptive design trials.
There is complete flexibility to modifying doses or treatments, introduce any new doses, react to unanticipated events, change endpoints, etc. With blinded data or limited participants that have access to the results, credibility of such results is maintained. Future prospects of adaptive design clinical trials are promising and encouraging for regulatory agencies, patients and industry. Although, there are challenges and obstacles associated with execution of adaptive design clinical trials, the application of these methods have made drug development process shorter, faster and cheaper.
Online Course in Clinical Research
James Lind Institute (JLI) provides an online program Post Graduate Diploma in Clinical Research that helps understand the conventional and advanced methodologies used in clinical research.
For more information please visit: www.jliedu.com