Determinants of patient screen failures in Phase 1 clinical trials

Alexandra McKane, Chao Sima, Ramesh K. Ramanathan, Gayle Jameson, Cathy Mast, Erica White, Sharon Fleck, Molly Downhour, Daniel D. Von Hoff, Glen J. Weiss

Research output: Contribution to journalArticle

1 Scopus citations

Abstract

Objective Certain eligibility criteria for Phase 1 cancer clinical trials may impede successful patient enrollment onto a study. We evaluated patient-specific or study-specific reasons for screen failures on Phase 1 oncology clinical trials and discuss factors which may inhibit subject enrollment. Methods Thirty-eight Phase 1 clinical trials for solid tumors meeting eligibility criteria and opened for enrollment between February 2006 and February 2011 at one oncology Phase 1 program were examined. Categorical reasons for screen failures and patients' demographics were examined and compared to characteristics of patients that successfully enrolled on a Phase 1 trial. Results There were a total of 583 successful Phase 1 enrollment and dose administration events out of 773 Phase 1 consent events (75.4 % dose success rate). The three most common reasons for screen failure were: out of protocol-specified range for chemistry, development of an interval medical issue that precluded proceeding with study participation, and subject declining participation after signing consent. Living further away from the Phase 1 program and receipt of fewer prior lines of systemic chemotherapy were significantly associated with increased screen failures. Conclusion Screen failures for Phase 1 studies are not uncommon (24.6 %). When a protocol required tumor or host analyte is not required, most screen failures are due to out of protocol-specified range for chemistry or the development of an interval medical issue. Screen failure rates were increased when patients had longer travel distances and fewer prior lines of systemic chemotherapy.

Original languageEnglish (US)
Pages (from-to)774-779
Number of pages6
JournalInvestigational New Drugs
Volume31
Issue number3
DOIs
StatePublished - Jun 1 2013

Keywords

  • Clinical trials
  • Eligibility criteria
  • Phase 1
  • Screen failure
  • Study design

ASJC Scopus subject areas

  • Oncology
  • Pharmacology
  • Pharmacology (medical)

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  • Cite this

    McKane, A., Sima, C., Ramanathan, R. K., Jameson, G., Mast, C., White, E., Fleck, S., Downhour, M., Von Hoff, D. D., & Weiss, G. J. (2013). Determinants of patient screen failures in Phase 1 clinical trials. Investigational New Drugs, 31(3), 774-779. https://doi.org/10.1007/s10637-012-9894-7