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ORIGINAL ARTICLE
Year : 2013  |  Volume : 4  |  Issue : 4  |  Page : 211-214

Feasibility study of clinical trial for breast cancer and lung cancer at Indian sites


1 Global Regulatory Medical Writer, Novartis Healthcare Pvt. Ltd., Hyderabad, Andhra Pradesh, India
2 Clininvent Research Pvt. Ltd., Mumbai, Maharashtra, India

Correspondence Address:
Varun M Mehta
Novartis Healthcare Pvt. Ltd., Building No. 6, K Raheja Mindspace, Hi Tech City, Madhapur, Hyderabad - 500 081, Andhra Pradesh
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2229-3485.120169

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Objective: The objective of this study was to conduct feasibility study of phase III breast and lung cancer clinical trials in India. Materials and Methods: Study synopsis and feasibility questionnaire were mailed to 300 oncologists for each indication. Criteria of selection were enrolment of ≥2 patients per month, frequency of Ethics Committee (EC) meeting ≤4 weeks, dropout rate <20%, adequacy of infrastructure and training of site in good clinical practice (GCP). Descriptive analyses of the data were performed. Results: For both indications, 50/300 (16.7%) sites responded. The median number of patients seen by a site per month for breast and lung cancer was 20 (range 0-300) and 10 (range 0-75), respectively. Median number of eligible patients was 4 (range 0-20) and 3 (range 0-15) per month, for breast and lung cancer respectively. The frequency of EC meeting was ≤4 weeks at 36-56% of sites. All sites were trained in GCP and had adequate infrastructure to conduct the clinical trial. For breast cancer 22 (44%) sites (public 14 [28%]; private 8 [16%)]), and for lung cancer 18 (36%) sites (public 15 [30%], private: 3 [6%]) met the criteria of selection. Conclusion: Preliminary feasibility study would require for confirmation of the important feasibility criteria by in depth discussion during the personal visit to the potential sites.


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