A collaborative research effort between IIT Guwahati, the National University of Singapore, and the University of Michigan has led to the development of a new multi-stage clinical trial method designed to personalize treatment plans in real time. This breakthrough aims to improve patient outcomes by dynamically adapting treatments based on individual responses, moving away from the traditional one-size-fits-all model.

Key Highlights:
Real-Time Treatment Adjustments:
The method tailors treatment plans based on each patient’s response during the clinical trial.

Dynamic Treatment Regimes (DTRs):
Helps adjust treatments as the patient’s condition evolves.
Enables switching drugs or combining therapies based on intermediate outcomes such as blood sugar levels in diabetes patients.

SMART (Sequential Multiple Assignment Randomized Trial) Methodology:
Unlike traditional trials, patients are reassigned treatments based on their response to earlier interventions.
Reduces unnecessary treatment failures and optimizes therapy choices dynamically.

New Adaptive Randomization Method:
Developed by the research team to improve treatment allocation efficiency.
Assigns patients to treatment arms based on real-time data, prioritizing better-performing treatment sequences.

Potential for Broader Public Health Applications:
Can be applied to chronic diseases, mental health, and substance abuse recovery programs.
Currently being explored in collaboration with Indian medical institutions for managing mental health issues using traditional Indian medicine.

Statements from Leaders or Officials:
Dr. Palash Ghosh, Assistant Professor, Department of Mathematics, IIT Guwahati:

• "Multi-stage clinical trials are essential for developing effective DTRs. Unlike traditional SMART trials, which allocate patients equally across treatment arms, our adaptive randomization dynamically assigns patients based on real-time trial data, increasing their chances of receiving effective treatments."

• "By focusing on both short-term and long-term outcomes, this method will enhance patient care and reduce treatment failures, making clinical trials more effective and patient-friendly."

The next phase of the research involves conducting SMART trials in collaboration with Indian medical institutions. This approach is expected to enhance the effectiveness of mental health treatments and optimize patient care for various chronic diseases. With a focus on personalized medicine, this innovation marks a significant step forward in modern clinical trial methodologies, ensuring that treatments are tailored to each patient’s unique medical needs.