title: Feasibility study of clinical trial for breast cancer and lung cancer at Indian sites.
abstract: OBJECTIVE
  The objective of this study was to conduct feasibility study of phase III breast and lung cancer clinical trials in India.
  
  
  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.
  
  
  CONCLUSIONS
  Preliminary feasibility study would require for confirmation of the important feasibility criteria by in depth discussion during the personal visit to the potential sites.
authors: Global Regulatory Medical Writer, Novartis Healthcare Pvt. Ltd., Hyderabad, Andhra Pradesh, India.
authors: Varun M
authors: VM
authors: Mehta
authors: Arun D
authors: AD
authors: Bhatt
keywords: Breast cancer; feasibility study; lung cancer