Biostatistical Guidelines
Adhere to the following biostatistical guidelines based on the type of abstract you are preparing. 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
Include the four sections previously described for all abstracts (Background, Methods, Results, and Conclusions), with the following essential data in the Methods and Results sections:
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, as well as 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, 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
Phase II Trials
Include the four sections previously described for all abstracts (Background, Methods, Results, and Conclusions), with the following essential data in the Methods and Results sections:
Methods
- Patient eligibility criteria
- Description of treatment
- Study design (e.g., one or two stage) 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 previously described for all abstracts (Background, Methods, Results, and Conclusions), with the following essential data:
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 previously described for all abstracts (Background, Methods, Results, and Conclusions), with the following essential data:
Background:
- Specification of the marker
Methods
- Patient eligibility criteria, if appropriate
- 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)
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
Correlative, Quality-of-life, Meta-analyses, Exploratory Analysis Studies, or Prevention
Include the four sections previously described for all abstracts (Background, Methods, Results, and Conclusions), with the following essential data in the Methods and Results sections:
Methods
- Study design for the analysis
- Definition of study endpoint(s)
- Description of method to evaluate outcome
Results
- Same criteria as for phase III trials that apply