ASCO有关临床试验的摘要投稿指南

分享到:0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 TrialsInclude the

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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 TrialsInclude 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 StudiesInclude 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

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