Biostatistical Guidelines

Submitting authors must adhere to the following biostatistical guidelines based on the type of abstract being prepared. Although the following elements are not required, the absence of one or more of these elements in an abstract may have a negative impact on the grading and selection process.

Phase III Trials and Phase II/III Trials

Include the four sections for all abstracts (Background, Methods, Results, and Conclusions), with the following essential data in each section

Methods

  • Patient eligibility criteria
  • Description of each treatment arm
  • Explicit definition of primary endpoint(s)
  • Statement of study design (e.g., randomized, prospective, placebo-controlled, stratified)
  • If analysis is prior to final analysis, indication of such, and if analysis was planned outline of early stopping guidelines, and reason for early reporting. In general, ASCO discourages reporting of interim results, unless approved by the study’s Data and Safety Monitoring Committee.
  • Planned sample size per arm, including assumptions (type I and type II error rates, whether it is one-sided of two-sided, null hypothesis, alternative hypothesis, or magnitude of expected change) 

Results

  • Accrual per arm, with duration of follow-up, if appropriate
  • Observed magnitude of difference for primary endpoint(s)
  • Confidence limits and/or probability values pertaining to endpoint(s), with inclusion of the statistical method of analysis
  • Was analysis based on intent-to-treat (ITT)?

For comparative randomized phase II, similar to phase III trials. For a noncomparative phase II trials, similar criteria as in phase II trials.

Phase II Trials

Include the four sections for all abstracts (Background, Methods, Results, and Conclusions), with the following essential data in each section

Methods

  • Patient eligibility criteria
  • Description of treatment
  • Study design (e.g., one or two stage) including assumptions (type I and II error rates, null, and alternative hypothesis) and planned sample size. In general, ASCO also discourages reporting of interim results of phase II trials. Although it is recognized that incomplete phase II trials are occasionally of major significance, in general, completed trials will be viewed more favorably during the grading process.
  • Definition of primary endpoint

Results

  • Accrual and eligibility
  • Point estimates and confidence intervals (where appropriate). Note that for most estimates, all eligible patients who received treatment should be considered in the denominator.

Phase I Trials 

Include the four sections for all abstracts (Background, Methods, Results, and Conclusions), with the following essential data in each section

Background

  • Drug/agent or target introduction

Methods

  • Patient eligibility
  • Description and criteria for dose escalation
  • Pharmacokinetic/pharmacodynamic assays, if any

Results

  • Accrual across dose levels
  • Dose-limiting toxicities
  • Recommended phase II dose
  • Pharmacokinetics
  • Correlative studies, if any

Tumor Marker Studies

Include the four sections for all abstracts (Background, Methods, Results, and Conclusions), with the following essential data in each section

Background

  • Specification of the marker

Methods

  • Patient eligibility criteria, if appropriate
  • Data source
  • Specimen format
  • Description of study arm(s), with treatment noted, if appropriate
  • Definition of study endpoint(s)
  • Study design (e.g., one or two stage), for the analysis
  • If the study is a test of hypothesis, power considerations for submitted analysis, including assumptions (null hypothesis, alternative hypothesis, magnitude of expected change, or effect size)
  • Statement of assay method used
  • Description of the assay quantitation and scoring methods along with a statement of whether marker values were used as categorical, ordinal, or continuous measures in statistical analyses (if cutpoints were used, indication of how they were selected)
  • Description of multiple comparisons strategies

Results

  • Accrual and duration of follow-up, if appropriate
  • Confidence limits and/or probability values pertaining to endpoint(s), with inclusion of the statistical method of analysis including methods to adjust on the type I error rate
  • Documentation evidence of reliability/validity if appropriate

Other Analyses

Other types of abstracts submitted include

  • Basket trial
  • Cohort
  • Correlative
  • Cost Analysis
  • Exploratory Analysis
  • Health Services Research
  • Meta-analysis
  • Observational
  • Preclinical
  • Prevention
  • Prospective
  • Qualitative
  • Quality of Life
  • Registry Regulatory
  • Retrospective
  • Systematic Studies

Include the four sections previously described for all abstracts (Background, Methods, Results, and Conclusions), with the following essential data 

Methods

  • Study design for the analysis
  • Definition of study endpoint(s)
  • Description of method to evaluate outcome

Results

  • Same criteria as for phase II, II/III, or III that apply