A sense of urgency: evaluating the link between clinical trial development time and the accrual performance of cancer therapy evaluation program (NCI-CTEP) sponsored studies.

Posted: Jan 26, 2011
Clin Cancer Res. 16. 22. 5557-63.
KEYWORDS: Institutional Issues

Highlights

The study provides an in-depth analysis of a critical, yet often overlooked, accrual barrier—clinical trial development time.

Why this item may be useful

As an important predictor of accrual success, trial development time should be included in any investigation of low accrual causes. Length of clinical trial development is inversely related to likelihood of achieving accrual goals. Reducing unnecessary delays and overcoming barriers in clinical trial development may significantly improve accrual.

Details

  • The study retrospectively investigated NCI Cancer Therapy Evaluation Program (CTEP)-sponsored therapeutic clinical trials over an 8-year period.
  • Time to open a study was defined as calendar days from initial CTEP submission of letter of intent or concept to trial opening to accrual.
  • The median time to open a study was 14.2 months.
  • Trials requiring less than 12 months of development were significantly more likely to achieve accrual goals than those requiring more than 24 months for development.
  • Among all the CTEP-approved trials, 37.9% failed to achieve minimum accrual goals.
  • Among Phase III trials, which have the longest development time, 70.8% failed to achieve minimum accrual goals.