Clinical trials analysis and reporting

Common clinical trial graphics are the focus of this chapter. First, we discuss the types of graphs that are most often encountered in clinical trial analysis and reporting. Then we examine the various tools that SAS provides to help produce these graphs. Sample graph programs are provided to show how many of these graphs can be produced. 

There are several types of graphs that are common to clinical trial analysis and reporting. What follows are some brief descriptions of these graphs. 

SAS has always had and will maintain a central role in the data management, analysis, and reporting of clinical trial data. Because of the strong suite of SAS statistical procedures and the power of Base SAS programming, SAS remains a favorite of statisticians for the analysis of clinical trial data. Several companies have built their clinical trial data management and statistical analysis systems entirely with SAS software. More recently, SAS has offered SAS Drug Development as an industry solution that provides a comprehensive clinical trial analysis and reporting environment compliant with 21 CRF-Part 11. 

The E9 discusses the statistical issues in the design and conduct of a clinical trial. It details trial design, trial conduct, and data analysis and reporting. Although most useful... 

Good Clinical Practice (GCP) is a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials. For more information on the FDA s GCP program, go to http //... 

Trial-related audits focus on a particular trial to assess compliance with the protocol, with related SOPs and applicable GCP regulations. Of particular interest is how trial participants are informed of the trial, the study activities conducted at the investigator sites and the procedures of clinical data handling, recording, processing, analysis and reporting. 

This late phase in clinical trials offers many opportunities to introduce errors and inconsistencies in the clinical trial data as obtained on the CRFs by the investigator sites. No stage before included so many steps for data processing, coding, cleaning, programming, analysis and reporting and requires seamless interaction of many contributors. 

Wang D, Bakhai A (eds) (2006) Clinical Trials A Practical Guide to Design Analysis and Reporting. Remedica, London,... 

In addition to the expedited reporting described above, sponsors shall submit, once a year throughout the clinical trial, or on request, a safety report to the Competent Authority and the Ethics Committee. This should cover SUSARs, other serious adverse reactions, and an analysis of the subjects safety during the course of the trial. 

A variety of data sources are available to inform interactive programs, including prospective data sets, retrospective databases, expert opinion, and unpub-lished/published literature. Time horizon, that is, the length of time into the future considered in the analysis over which costs and outcomes are projected, is very important here [26]. For example, if a clinical trial or the published literature only report short-term results for a chronic condition, the outcomes may come into question. This is where decision-analytic models may come... 

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