
GUWAHATI: Researchers at the Indian Institute of Technology Guwahati, in collaboration with leading institutions worldwide, have developed an innovative multi-stage clinical trial method aimed at revolutionizing personalised medical care. This cutting-edge approach adapts treatment plans in real-time based on each patient's unique responses during trials, enabling highly tailored and effective healthcare solutions.
The research, conducted in partnership with Duke-NUS Medical School, the National University of Singapore, Singapore, and the University of Michigan, USA, focuses on Dynamic Treatment Regimes (DTRs) designed through Sequential Multiple Assignment Randomized Trials (SMARTs).
DTRs are advanced decision rules that adapt treatments dynamically as a patient's condition evolves. For example, if a diabetes patient does not respond well to an initial medication, the DTR might recommend switching drugs or combining therapies.
Multi-stage clinical trials are essential for developing effective DTRs, and SMART methodology enables researchers to test various treatment sequences to find the best fit for each patient. Unlike traditional trials, SMART involves multiple stages of treatment, where patients are reassigned to different interventions based on their responses at each stage. This adaptive approach not only enhances the precision of treatment but also allows for real-time adjustments, ensuring that patients receive the most effective care throughout their treatment journey to different interventions based on their responses. This dynamic approach not only enhances the personalization of care but also allows for real-time adjustments, improving patient outcomes and overall treatment efficacy based on their responses to earlier interventions.
Traditional SMART trials assign patients to treatment arms in equal numbers, even when some treatments prove less effective, based on interim data. This often leads to unnecessary treatment failures. Dr. Palash Ghosh and his team have developed an adaptive randomization method that dynamically assigns patients to treatment arms based on real-time trial data by optimally changing the patient allocation ratios in favour of a better-performing treatment sequence than in the trial.
Speaking about the research, Dr. Palash Ghosh, Assistant Professor, Department of Mathematics, IIT Guwahati, said, "Adaptive designs like this would encourage more patient participation in clinical trials like SMART. When patients see they are receiving treatments tailored to their needs, they are more likely to stay engaged. This approach also has vast potential for public health interventions, such as tailoring substance abuse recovery plans to individual needs as well as in other chronic diseases," stated a press release.
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