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Unequal allotment of patients in phase III oncology clinical trials

Shruti Gupta1, Shefali Jain1, Justin Yeh1

  • 1Medical College of Georgia, Augusta University Augusta, GA 30909, USA.

American Journal of Cancer Research
|August 6, 2021
PubMed

Insights

Unequal patient allocation in phase 3 cancer clinical trials is becoming more common, representing about one in four two-arm trials. This trend, observed between 2010-2019, may aid adverse event monitoring.

Area of Science:

  • Oncology
  • Clinical Trial Design
  • Biostatistics

Background:

  • Traditionally, cancer clinical trials employed equal distribution between case and control arms.
  • Recent trends indicate a shift towards unequal allocation in some cancer clinical trials.

Purpose of the Study:

  • To analyze the trends and proportion of phase 3 cancer clinical trials utilizing unequal allocation between 2010 and 2019.
  • To identify cancer types most frequently using unequal allocation in trial design.

Main Methods:

  • Data were extracted from clinicaltrials.gov for randomized controlled trials focused on cancer treatment.
  • Trials with available allocation data from 2010-2019 were analyzed, categorizing them by arm number (2 or 3) and allocation type (equal vs. unequal).

Main Results:

  • Out of 323 two-arm trials, 85 (approximately 26%) exhibited unequal allocation.
  • Among 35 three-arm trials, 9 (approximately 26%) showed unequal allocation.
  • Gastrointestinal, breast, and genitourinary cancers were most frequently associated with unequally allocated two-arm trials.
  • No significant change in the annual proportion of unequally allocated trials was observed from 2010 to 2019.

Conclusions:

  • Unequal allocation is a notable design feature in approximately one-quarter of phase 3, two-arm cancer clinical trials.
  • This design may be adopted to enhance adverse event monitoring, despite potential drawbacks like increased costs and reduced statistical power.
  • Further research may explore the long-term impact and rationale behind this evolving trial design trend.
Keywords:
Unequal allotmentrandomized controlled trialstrends

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