ICMR signs pacts for clinical trials for four drug molecules

Sub: Sci

Sec: Health

Context:

The Indian Council of Medical Research (ICMR) has formalised Memorandums of Agreement (MoAs) with multiple sponsors under its ‘Network for Phase 1 Clinical Trials’.
The agreements mark an entry into first-in-human clinical trials for four promising molecules, the council said.

The four agreements:

Collaborative research over a small molecule for multiple myeloma with Aurigene Oncology Limited with Indian Immunologicals Limited
Coordinating a seasonal influenza virus vaccine trial with Mynvax Private Limited
CAR-T cell therapy advancement study for a new indication of chronic lymphocytic leukaemia with ImmunoACT.

Significance:

It is a crucial step towards establishing India as a leader in the clinical development of pharmaceutical agents.
The collaboration between ICMR and prominent industry and academic partners is a key milestone in the pursuit of affordable and accessible cutting-edge treatments for all citizens.

ICMR’s ‘Network for Phase 1 Clinical Trials’

The network is designed to enhance India’s capacity to conduct early phase clinical trials, supported by robust infrastructure and dedicated manpower at each trial site, ensuring smooth and effective operations.
The network comprises of four strategically located institutions across India
- King Edward Memorial Hospital and Seth Gordhandas Sunderdas Medical College, Mumbai
- Advanced Centre for Treatment, Research and Education in Cancer, Navi Mumbai
- SRM Medical College Hospital and Research Centre, Kattankulathur
- Postgraduate Institute of Medical Education and Research, Chandigarh.
They are supported by the Central Coordinating Unit at the ICMR’s headquarters in New Delhi.

4 stages of clinical trials:

Phase I:
- This is the first time where the new drug is administered to a small number, a minimum of 2 healthy, informed volunteers for each dose under the close supervision of a doctor.
- The purpose is to determine whether the new compound is tolerated by the patient’s body and behaves in the predicted way.
Phase II:
- During this phase, the medicine is administered to a group of approximately 10-12 informed patients in 3 to 4 centres to determine its effect and also to check for any unacceptable side effects.
Phase III:
- Purpose is to obtain sufficient evidence about the efficacy and safety of the drug in a larger number of patients, generally in comparison with a standard drug and/or a placebo as appropriate.
- In this phase, the group is between 1000-3000 subjects.
- If the results are favourable, the data is presented to the licensing authorities for a commercial license to market the drug for use by the patient population for the specified and approved indication.
Phase IV:
- Phase of surveillance after the medicine is made available to doctors, who start prescribing it.
- The effects are monitored on thousands of patients to help identify any unforeseen side effects.