Modifying the Clinical Research Infrastructure at a Dedicated Clinical Trials Unit: Assessment of Trial Development,

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Chad Tang1, Kenneth R Hess2, Dwana Sanders3

  • 1Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas. CTang1@mdanderson.org dshong@mdanderson.org.

Clinical Cancer Research : an Official Journal of the American Association for Cancer Research
|November 18, 2016
PubMed

Insights

Implementing a dedicated clinical research infrastructure accelerates investigational cancer therapeutics trials, improving activation timelines and patient enrollment in academic cancer centers.

Area of Science:

  • Oncology
  • Clinical Trial Management
  • Translational Research

Background:

  • Information on clinical trial development processes, particularly for investigational therapeutics, is limited.
  • Optimizing trial timelines and patient accrual is crucial for advancing cancer treatment research.

Purpose of the Study:

  • To assess the trial development processes within the Department of Investigational Cancer Therapeutics (ICT) at MD Anderson Cancer Center.
  • To analyze the impact of the ICT's infrastructure on trial activation timelines and patient enrollment.

Main Methods:

  • A prospectively maintained registry of all clinical studies at MD Anderson was utilized.
  • 2,261 activated phase I-III trials were identified, with 221 from ICT, matched to non-ICT trials by phase, sponsorship, and submission year.
  • Trial performance metrics were compared using paired Wilcoxon signed rank tests.

Main Results:

  • The ICT infrastructure features parallel processing, a physician-led team, and regular accountability meetings.
  • ICT trials demonstrated faster activation from Institutional Review Board (IRB) approval to activation and from activation to first enrollment compared to non-ICT trials.
  • ICT trials showed significantly higher patient accrual rates and faster participant enrollment.

Conclusions:

  • A clinical research-focused infrastructure in an academic cancer center is associated with efficient trial development.
  • Streamlined processes within the ICT department led to improved trial activation and patient accrual.
  • These findings highlight the importance of specialized infrastructure for accelerating therapeutic development in oncology.

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