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Lessons learned from a failed multi-institutional randomized controlled study.

P F Ehrlich1, K D Newman, G M Haase

  • 1Surgical Committee of the Children's Cancer Group, Pediatric Oncology Group, Virginia University, Morgantown, WV 26505-9238, USA.

Journal of Pediatric Surgery
|March 6, 2002
PubMed
Summary
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A pediatric cancer surgery trial failed due to low patient enrollment. Key factors included issues with Institutional Review Board (IRB) submission, insufficient minimally invasive surgery (MIS) expertise among surgeons, and surgeon bias regarding surgical approaches.

Area of Science:

  • Pediatric Oncology
  • Surgical Oncology
  • Clinical Trial Design

Background:

  • A prospective, randomized, controlled study evaluating minimally invasive surgery (MIS) in pediatric cancer patients was funded in 1996.
  • The study, involving the Children's Cancer Group (CCG) and Pediatric Oncology Group (POG), closed prematurely in 1998 due to insufficient patient accrual.

Purpose of the Study:

  • To identify and analyze factors contributing to the clinical trial's failure.
  • To provide insights for designing more successful future clinical trials in pediatric surgical oncology.

Main Methods:

  • A questionnaire was distributed to 140 surgeons from CCG and POG member institutions.
  • The survey assessed study objectives, organization, Institutional Review Board (IRB) submission processes, surgeon's MIS proficiency, oncologist influence, and potential biases among surgeons, oncologists, and families.

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Main Results:

  • Only 62% of surgeons responded; 23% of potential protocols were submitted for IRB approval.
  • Surgeon support correlated with protocol receipt timing and active MIS participation (P <.001, P <.016).
  • Oncologist support influenced IRB submission (P <.02), affected by institutional MIS practice (P <.05). Surgeons perceived bias within their communities (P <.001), but not among families (P >.05).

Conclusions:

  • The trial's lack of accrual stemmed from multiple issues: failure to obtain IRB approval, inadequate surgeon expertise in MIS, and surgeon bias favoring either endoscopic or open surgical methods.