title: Reasons why patients fail screening in Indian breast cancer trials.
abstract: BACKGROUND
  An increased number of screen failure patients in a clinical trial increases time and cost required for the recruitment. Assessment of reasons for screen failure can help reduce screen failure rates and improve recruitment.
  
  
  METHODS
  We collected retrospective data of human epidermal growth factor receptor (HER2) positive Indian breast cancer patients, who failed screening for phase 3 clinical trials and ascertained their reasons for screen failure from screening logs. Statistical comparison was done to ascertain if there are any differences between private and public sites.
  
  
  RESULTS
  Of 727 patients screened at 14 sites, 408 (56.1%) failed screening. The data on the specific reasons for screen failures was not available at one of the public sites (38 screen failures out of 83 screened patients). Hence, after excluding that site, further analysis is based on 644 patients, of which 370 failed screening. Of these, 296 (80%) screen failure patients did not meet selection criteria. The majority -266 were HER2 negative. Among logistical issues, 39 patients had inadequate breast tissue sample. Sixteen patients withdrew their consent at private sites as compared to six at public sites. The difference between private and public sites for the above three reasons was statistically significant.
  
  
  CONCLUSIONS
  Use of prescreening logs to reduce the number of patients not meeting selection criteria and protocol logistics, and patient counseling to reduce consent withdrawals could be used to reduce screen failure rate.
authors.affiliation: Department of Clinical Operations, Clininvent Research Pvt. Ltd, Mumbai, India.
authors.forename: P
authors.initials: P
authors.lastname: Mahajan
authors.affiliation: Department of Medical and Regulatory Affairs, Clininvent Research Pvt. Ltd, Mumbai, India.
authors.forename: A
authors.initials: A
authors.lastname: Kulkarni
authors.affiliation: Department of Clinical Operations, Clininvent Research Pvt. Ltd, Mumbai, India.
authors.forename: S
authors.initials: S
authors.lastname: Narayanswamy
authors.affiliation: Department of Clinical Operations, Glaxosmithkline Pharmaceuticals Ltd, Mumbai, India.
authors.forename: J
authors.initials: J
authors.lastname: Dalal
authors.affiliation: Department of Clinical Operations, Glaxosmithkline Pharmaceuticals Ltd, Mumbai, India.
authors.forename: V
authors.initials: V
authors.lastname: Halbe
authors.affiliation: Department of Clinical Operations, Glaxosmithkline Pharmaceuticals Ltd, Mumbai, India.
authors.forename: S
authors.initials: S
authors.lastname: Patkar
authors.affiliation: President, Clininvent Research Pvt. Ltd, India.
authors.forename: A
authors.initials: A
authors.lastname: Bhatt
keywords: Breast cancer; consent withdrawal; patient enrolment; screen failure; selection criteria