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Ethics of randomized trials in pediatric surgery

Rebecca M Rentea1, Tolulope A Oyetunji2, Shawn D St Peter2

  • 1Pediatric Surgery, Comprehensive Colorectal Center, Children's Mercy Hospital, 2401 Gillham Road, Kansas City, MO, 64108, USA. rrentea@cmh.edu.

Pediatric Surgery International
|May 13, 2020
PubMed

Insights

Pediatric surgeons must participate in randomized controlled trials (RCTs) to advance evidence-based care for children. Unique ethical challenges in pediatric surgical RCTs require careful consideration during trial design and implementation.

Area of Science:

  • Pediatric Surgery
  • Clinical Trials
  • Medical Ethics

Background:

  • Evidence-based treatment for pediatric surgical conditions requires robust clinical trial data.
  • Pediatric surgeons' involvement in randomized controlled trials (RCTs) is crucial for evaluating new treatments and innovations.
  • Ethical considerations in pediatric surgical research present unique challenges compared to adult trials.

Purpose of the Study:

  • To review the ethical aspects specific to pediatric surgical randomized controlled trials (RCTs) and prospective comparative studies.
  • To highlight the practical difficulties encountered in designing and conducting clinical trials in pediatric surgery.
  • To emphasize the importance of addressing unique ethical issues for advancing pediatric surgical care.

Main Methods:

  • Review of ethical considerations in pediatric surgical randomized controlled trials (RCTs).
  • Analysis of practical difficulties in the design and performance of clinical trials involving children.
  • Identification of specific ethical issues unique to pediatric surgical research.

Main Results:

  • Pediatric surgical RCTs face challenges such as low disease volume, inability to conduct early-phase trials, and parental emotional involvement.
  • Recruitment difficulties, modified study designs, and issues with consent (permission vs. assent) are significant ethical hurdles.
  • Investigator bias can also impact the integrity of pediatric surgical clinical trials.

Conclusions:

  • Addressing the unique ethical considerations is paramount for successful pediatric surgical randomized controlled trials (RCTs).
  • Careful study design and ethical oversight are necessary to overcome challenges in pediatric surgical research.
  • Enhanced participation of pediatric surgeons in clinical trials will improve evidence-based care for children.

Keywords:
EthicsPediatric surgeryRandomized control trial (RCT)

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