Coordination of Multicentre Trials:

CRU oversees the multicentre clinical trial conducted by the Indian Childhood Collaborative Acute Lymphoblastic Leukaemia (ICiCLe) group. This trial focuses on children aged 1 - 18 diagnosed with acute lymphoblastic leukaemia, ensuring systematic collaboration among multiple centers.

CRU also coordinates The Indian Paediatric Oncology Group collaborative multicentre treatment protocol for children and adolescents with relapsed acute lymphoblastic leukaemia.

Implementation Research:

Hub under ISCALL: Post the ICiCLe - ALL 2014 initiative, TATA Medical Centre serves as a central hub under the Improving Survival in Childhood Acute Lymphoblastic Leukaemia (ISCALL) framework. CRU acts as a clinical trial and statistical unit, facilitating comprehensive data management and implementation research efforts.

Research on Asparaginase:

CRU conducts critical studies on Asparaginase, a key chemotherapeutic drug for ALL. This includes pharmacological monitoring and identifying quality Asparaginase biogenerics; current efforts include population pharmacokinetic modeling to optimize individual dosing. Collaborating with biopharma, we are initiating a clinical trial to assess the safety and efficacy of a new indigenously manufactured recombinant Asparaginase biotherapeutic, assessing its safety and efficacy.

Toxicity Management:

ICiCLe sub - studies, managed by CRU, include toxicity assessments that utilize risk-stratified treatment strategies. These approaches aim to improve cure rates while minimizing acute and long - term treatment - related toxicities.

Clinical Decision Support System (CDSS):

In partnership with Tata Consultancy Services, CRU has developed a clinical decision support system (CDSS), referred to as ADAM, 'automated dose advice in ALL maintenance', to assist prescribers with drug titration decisions in accordance with the 'titrate to tolerance' principle to adjust oral antimetabolite drug dosages. In parallel, efforts are underway to refine drug treatment during ALL maintenance, including evaluating the use of biomarkers in drug titration decisions, examining the use of oral adjuvants to reduce toxicity and/or augment efficacy, and introducing alternative drug formulations to enable continuous uniform daily dosing.