CLINICAL TRIAL UNIT (MCC-CTU)

National BiopharmaMission is An Industry-Academia Collaborative Mission of the Department of Biotechnology (DBT) for Accelerating Early Development for Biopharmaceuticals; to be implemented by Biotechnology Research Assistance Council (BIRAC).

 

The Mission Programme is a Pan-India Programme with the main aim of making India a hub for the design and development of novel, affordable and effective biopharmaceutical products and solutions. This Program would aid in enhancing India’s innovation research and product development capabilities, especially by focusing on development of vaccines, biologics and medical devices for combating public health concerns.

Clinical trial is an important step in the product development path requiring multiple trial sites. Indian Biotech companies face numerous challenges in identifying trial sites which have the required infrastructure, capacity, trained manpower, harmonized processes and background data on disease incidence at institutional, local, regional/state, and national levels. The delay in conduct of clinical trials can impact the development timelines of biologics and drugs and thereby delaying the launch of affordable bio similar for Indian population.

To address the above, Department of Biotechnology and National Biopharma Mission’s initiative, formed the clinical trial units within the National Cancer Grid (NCG) to promote multi-centric high-quality clinical trials for affordable therapy in oncology, which will enhance the capability for conduct of Industrysponsored trials of new cancer drugs and biosimilars.

MCC PGIOSR (Post Graduate Institute of Oncology Science & Research) is one of the selected site out of the 11 major cancer centres across India. Tata Memorial Hospital, Mumbai is the Lead site of the multi-centric Clinical Trial Network (CTN) entitled “To establish a ready network of clinical trial units across the National Cancer Grid to promote multi-centric collaborative research in the field of drug and device development”.

Prospective Registry database in Lymphomas, Chronic MyelogenousLeukemia, Colorectal Cancer, Lung Cancer, and Gall Bladder Cancer is being created across sites of the network.

The Malabar Cancer Center is currently conducting a number of trials, including those supported by pharmaceutical companies and those that are investigator-initiated. We have a committed, highly skilled, and trained clinical trial research team, including a project manager, clinical trial coordinators, research pharmacist, research nurses, and data entry operators, working under the auspices of the CTN network who are trained on Good Clinical Practice (GCP), New Drug Clinical Trial rules 2019 (NDCT-2019), Indian Council of Medical Research (ICMR) guidelines. The institution has 61 academic faculty members who are working under the 15 departments and 40 divisions and have adequate research backgrounds to carry out clinical trials.

Benefits of Collaboration with Clinical Trial Network- BIRAC:

1. Uniform and established SOPs across the network.

2. Access to a larger pool of patients with different geographical regions.

3. Highly qualified and experienced staff.   

4. Easy line of contact. 

5. Calibrated equipment.

List of the hospitals in Clinical Trial Network-BIRAC

S. No.	Hospital Name	Geographic Location	Name of Principal Investigator
1	Tata Memorial Hospital	Parel, Mumbai	Dr. RajendraBadwe
2	ACTREC, Kharghar	Navi Mumbai	Dr. JayantSastriGoda
3	Dr Bhubaneswar Borooah Cancer Institute	Guwahati, Assam	Dr. Ashok Kumar Das
4	Homi Bhabha Cancer Hospital	Varanasi, UP	Dr. Satyajit Pradhan
5	Cancer Institute WIA	Chennai, Tamil Nadu	Dr. SelvaluxmyGanesharajah
6	Malabar Cancer Centre,	Thalassery, Kerala	Dr. SatheesanBalasubramanian
7	Max Super Specialty Hospital	Saket, New Delhi	Dr. NiteshRohatgi
8	NEIGRIHMS,	Shillong, Meghalaya	Dr. Caleb Harris
9	Regional Cancer Centre,	Thiruvananthapuram, Kerala	Dr. Beela Sarah Bathew
10	Christian Medical College,	Vellore, Tamil Nadu	Dr. Vikram Mathews
11	Cachar Cancer Hospital	Assam	Dr. Ravi Kannan

Environmental Health Risk Management Plan (EHRMP)

Click here to download Environmental Health Risk Management Plan (EHRMP)