Some Guidelines for Interim Data Review of Clinical Trial Data
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Dennis W. King, PhD President and CEO, STATKING Consulting, Inc., Cincinnati, Ohio Jeremy D. Jokinen, MS Director of Statistics and Data Management, STATKING Consulting, Inc., Cincinnati, Ohio
Key Words Interim data review; Interim data review plan; Interim data monitoring Correspondence Address Dennis W. King, PhD, STATKING Consulting, Inc., 759 Wessel Drive, Unit 6, Fairfield, OH 45014 (email: statking@ statkingconsulting.com).
Some Guidelines for Interim Data Review of Clinical Trial Data
INTRODUCTION In what began as a way to check and improve data quality as a clinical trial progressed, interim data review (IDR) is carried out in most industry-sponsored clinical trials. IDR can be described as a process consisting of summarizing data from a clinical trial at various points during the trial for review by sponsor personnel. The methods of summarization used would not require the sponsor to modify the statistical design or statistical conduct of the trial as interim data become available for review. As the costs to develop new drugs and medical devices continue to increase, sponsors of clinical trials want more information earlier in the development process in order to make decisions on product development programs. Additionally, technological advances such as electronic data capture and electronic patient-reported outcomes have made information increasingly accessible to study personnel. The old adage “be careful what you wish for” is a familiar refrain from statisticians who realize that both positive and negative (perceived or real) news during a trial can cause a variety of consequences within the sponsor’s organization with rippling effects to the sponsor’s service providers. In the following sections, some guidelines are discussed for IDR of clinical trial data while the study is in progress. The conduct of IDR during
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This article describes guidelines for interim data review for industry-sponsored clinical trials. Interim data review includes all types of data review during the progress of a clinical trial that do not affect the statistical design (type I error adjustments) or statistical conduct (such as decisions to stop for futility or superiority based on hypothesis tests) of the trial. A set of levels of interim data review are described and procedures are given for documentation of the interim data review by the sponsor. A discussion of sponsor risks related to interim data review is included in the article along with recommendations for sponsor conduct of interim data review.
a clinical trial is not to be confused with interim data analyses, sample size reestimation, or adaptive trial design, all of which involve modification of the statistical design or conduct of the trial based on partial data from the trial.
I N T E R I M D ATA R E V I E W I N B L I N D E D TRIALS In double-blind clinical trials, the sponsor may review interim data for the purpose of identifying incorrect data or for facilitating business decisions. These data examinations may involve a small amount of data, such as a
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