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Clinical studies division

  • Introduction:

    The Clinical Studies Division of Saroj Gupta Cancer Centre & Research Institute has been operational since 2012. Over the years, the department has seen numerous commercial clinical trials, both national and global, to completion. The site also carries out investigator-initiated studies. This site is approved by Cervix Cancer Research Network (CCRN) of the Gynecologic Cancer InterGroup (GCIG). The division is headed by Dr Rahul Roy Chowdhury who is a gynaecological oncologist by profession, the Clinical Trials Administrator of Saroj Gupta Cancer Centre & Research Institute and a GCP – certified Principal Investigator himself. The division also has on employment, an experienced full-time clinical research coordinator to ensure smooth and timely conduct of all clinical research activities.

  • Why do clinical trials in sgcc&ri?

    This site is considered one of the premier institutes for conducting clinical research in eastern India, owing to continuous patient in-flow which ensures adequate participant population. The recent statistics depicting these are given here:

    TARGET AREA/CASE 2016-2017 2017-2018
    Lung cancer 659 606
    Breast cancer 756 780
    Head and neck cancer 650 630
    Uterine cancer 64 62
    Cervical cancer 380 379
    Ovarian cancer 166 158
    Urological cancers 400 377

    High patient volume along with availability of all modern and up-to-date investigative and therapeutic equipment under one roof, reasonable cost of therapy, a dedicated team of GCP qualified clinicians and support staff and a stringent Institutional Ethics Committee (IEC) ensures high quality clinical research conduct. Clinical Studies Division also specializes in translating essential documents from English to regional language (Bengali and Hindi).

    This site is considered one of the premier institutes for conducting clinical research in eastern India, owing to continuous patient in-flow which ensures adequate participant population. The recent statistics depicting these are given here:

  • Past and ongoing clinical trials:

    Sl No. Study Name Principal Investigator (PI) Current Status
    1. Phase II clinical study to evaluate the efficacy and safety of NRC-AN-019 in cancer patients failing prior standard therapies Dr Samir Bhattacharyya Study closed out
    2. A randomized, multiple dose, multi centre, comparative parallel study to evaluate the efficacy, safety and pharmacokinetic characteristics of intravenous infusion of Rituximab (Hetero) and Reference, Medicinal Product (Rituximab, Roche) in Indian patient of Non-Hodgkin’s Lymphoma (HERILY Study) Dr Rabindranath Ghosh Study closed out
    3. A prospective, multicentric, randomized, open label, parallel group, comparative, two arms, safety, efficacy and pharmacokinetic study of Trastuzumab, (Manufactured by Intas Pharmaceuticals Limited, Biopharma Division, Ahmedabad, India) in comparison with Reference Biologic (Trastuzumab, Marketed by Roche) in the patients with HER2-Overexpressing Metastatic Breast Cancer Dr Tamohan Chaudhuri Study closed out
    4. A multi-center, randomized open label study to assess the systemic exposure, effectiveness and safety of taking 450 mg Ceritinib with low-fat diet and 600 mg Ceritinib with low-fat diet as compared with 750 mg Ceritinib in fasting condition in adult patients with ALK rearranged (ALK positive) metastatic non-small cell lung cancer (NSCLC) Dr Rakesh Roy Awaiting close out
    5. A Multi-Centre, Randomized, Double Blind, Parallel-Group, Comparative Clinical Trial to evaluate the Safety and Clinical Equivalence of Generic Clotrimazole Troche/Lozenges USP, 10mg (Unique Pharmaceutical Laboratories, India) to Clotrimazole Troche/Lozenges ® 10mg (Roxane Laboratories Inc., USA) in subjects with Oropharyngeal Candidiasis Dr Dhrubajyoti Mukhopadhyay Study closed out
    6. A phase III multicentre trial of weekly induction chemotherapy followed by standard chemoradiation versus standard chemoradiation alone in patients with locally advanced cervical cancer Dr.Rahul Roy Chowdhury Open to recruitment
    7. An observational, multicentre, Prospective study to evaluate concordance of detecting EGFR mutation by circulating tumour free DNA versus tissues biopsy in NSCLC (CONCORDANCE) Dr Rakesh Roy Open to recruitment
  • How to get clinical trials approved & started in sgcc&ri?

    Approach either PI or Clinical Studies Division/Research Coordinator with study proposal. If approaching the Clinical Studies Division, a suitable PI for the study will be suggested. If PI directly is approached, he/she will forward all information to the Clinical Studies Division.

    The PI will then present the case to the Research Subcommittee (RSC) (hyperlink). Should the RSC approve the study, the same shall be tabled in the next Institutional Ethics Committee meeting (IEC meeting is held every 3 months)

    All EC dossiers must be submitted to the IEC (hyperlink) at least 21 days prior to the scheduled meeting date. The EC dossiers must include all essential documents. Special emphasis is given on site-specific Informed Consent Forms for the regional languages i.e. Bengali and Hindi. The translations of the English ICFs must be lucid enough for the lay person to understand, without compromising on the actual content of the document.

    Once the IEC approval for a study is received, the Clinical Trial Agreement (CTA) is finalized.

    After the CTA is in place, proceed for site initiation and recruitment.

  • Our Team

    Dr Rahul Roy Chowdhury

    Clinical Trials Administrator
    MBBS, FRCOG (UK)

    Dr Tamohan Chaudhuri;

    Principal Investigator
    MD, DMRT (TMH MUMBAI)

    Dr Rakesh Roy

    Principal Investigator
    MD, ECMO, Dip Pall Med (UK)

    Ms Srijoni Sarkar

    Clinical Research Coordinator
    M. Pharm (Pharmacology)