Blind review

Any final decisions regarding combinations should be made at the Blind Review stage prior to breaking the blind. 

We will discuss the decision-making process with regard to the Statistical Analysis Plan and the Blind Review in Section 16.3. 

If new knowledge becomes available regarding important covariates after completion of the statistical analysis plan then modify the plan at the blind review stage. 

The definition of a per-protocol set of subjects allows us to get closer to the scientific question by including only those patients who comply with the protocol to a defined extent. The per-protocol set, like the full analysis set, must be prespecified in the protocol and then defined at the patient level at the blind review, following database lock, but before breaking the blind. It must be noted, however, that the per-protocol set is subject to bias and further, tends to overestimate the treatment effect. For this reason it is usually used only as a secondary analysis, supportive hopefully of the findings based on the full analysis set. 

The blind review does offer an opportunity to make some final changes to the planned statistical methods and this opportunity should not be missed but remember this is based on blinded data. 

An outlier is an unusual data point well away from most of the data. Usually the outlier in question will not have been anticipated and the identification of these points and appropriate action should be decided at the blind review. 

There is one final opportunity to revisit the proposed methods of statistical analysis prior to the breaking of the blind, or in an unblinded trial, before the statistics group have seen study data. This so-called blind review usually takes place around the time of database lock and the following lists some of the aspects of analysis that would generally be considered ... 

Under normal circumstances the blind review should take place over a 24 or 48 hour period to limit delays in beginning the analysis proper. The blind review should be documented, detailing precisely what was done. 

Sometimes the blind review can throw up data issues that require further evaluation by the data management group with data queries being raised, and these perhaps may result in changes to the database. This sequence of events can cause major headaches and delays in the data analysis and reporting, and so it is important in the planning phase to get the data validation plan correct so that issues are identified and dealt with in an ongoing way. 

When a manuscript is submitted for consideration, peer review provides the editor with advice on whether to accept the manuscript for publication. Reviewers also provide suggestions for improving the manuscript. The decision on whether to accept the manuscript for publication rests solely with the editor. Reviewers provide additional expertise and have perspectives that may complement that of the editor. Customarily, peer review is anonymous the identities of reviewers are not revealed by editors. Some journals also hold authors names and affiliations in confidence, a double-blind review approach. Occasionally, reviewers request... 

The [statistical] plan should be reviewed and possibly updated as a result of the blind review of the data. .. and should be finalized before breaking the blind. Formal records should be kept of when the statistical... 

The addition of extra placebo patients adversely affects efficiency and there are many circumstances under which it should be accepted that the most sensible course is to run the trial in an open fashion. It may be possible to include other safeguards such as blinded review of certain outcomes, but the fact that the most sensible design for some practical and economic phase IV type questions is an open-label study is probably insufficiently appreciated. 

American Foundation for the Blind Reviews products for persons who are blind or have low vision. Produces fact sheets on many topics. 

All chapters have gone through a rigorous, double-blind review process before acceptance. It is hoped that the readers will find these chapters informative, enlightening, and helpful. 

I want to thank all the authors for their excellent contributions to this book. Fm also grateful to all the reviewers, including most of the contributing authors, who served as referees for chapters written by other authors, and provided constructive and comprehensive reviews in the double-blind review process. 

This book includes research contributions of geographically dispersed authors from Asia, Africa, Americas, and Europe. The high scientific quality of the chapters was assured by a rigorous double-blind review process implemented by the ICLS 2015 organizers. 

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