ASCO有关临床试验的摘要投稿指南

下面是ASCO有关临床试验的摘要投稿指南，主要针对临床研究设计和统计学进行严格规定。这也表明，作为一个规范的临床试验，需要遵循研究的基本原则。这些要求实际上在研究设计阶段就应该全面考虑，也是一个临床试验的核心所在。

Phase III Trials

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

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 in the Background, Methods, and Results sections:

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

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  or phase II trials that apply