Reporting clinical trials

Notice the missing column for visit 2. This is exactly what you would expect PROC TRANSPOSE to give you. PROC TRANSPOSE transposed the data that were present and could not be expected to know about visits that are not represented in the data. However, often in clinical trials reporting you want to report on all visits, treatments, or other expected parameters whether they are represented in the actual data or not. In this case, a DATA step with arrays is a better choice to transform the data. Here is an example of the previous transposition that includes all visits 1-5, regardless of which visits are included in the underlying data. 

This chapter first explores the general approach to creating any statistical table or listing. Then it examines PROC REPORT and PROC TABULATE as possible stand-alone methods of clinical trial reporting. Next, examples of several common clinical trial tables are presented. Finally, issues concerning the appearance of the output are discussed. 

It produces only columnar-style reports and not the matrix-style reports required by clinical trial reporting. 

Much like the previous demographics table example, the majority of the tables generated for clinical trial reporting compare a set of continuous and/or categorical variables across treatment groups. The purpose is to see whether therapy groups are comparable or whether they differ in some way. These kinds of tables include the following ... 

If you need to repeatedly regenerate your PDF file, as is often the case in clinical trial reporting, it is easier to integrate PostScript files into a single PDF file with an automated scripted process such as the one listed above. Integrating multiple PDF files into a single PDF file is possible, but it is a manual process within Adobe Acrobat. 

Bar charts can represent data similar to the data represented by a line plot, but in a visually different way. Sometimes bar charts are requested in clinical trial reporting instead of a line plot. The following example shows the data from the previous line plot represented as a bar chart. 

There are a number of SAS procedures that help to build the graphics most common to clinical trial reporting. The following table describes which SAS procedures make which graphs. 

The submission must be formatted in a manner that is consistent with the requirements of the regulatory agency that will review the submission. The dossier may include 20 or more individual clinical trial reports. They should be uniform in format to assist the reader to assimilate evidence readily and to compare it between trials. The whole dossier should be one of accuracy, consistency and meticulous cross-referencing. Once again, the effort to reach these objectives must be made in the early planning stages. 

HIV-infected women Although megestrol has been used extensively in women for endometrial and breast cancers, its use in HIV-infected women has been limited. All the women in the clinical trials reported breakthrough bleeding. 

CIOMS. The development safety update report (DSUR) harmonizing the format and content for periodic safety reporting during clinical trials (Report of CIOMS Working Group VII). Geneva Counsil for International Organizations of Medical Sciences 2006. 

The specific immunosensitizing therapy for the treatment of allergic diseases is the main etiological therapeutic tool, as demonstrated by many doubleblind placebo-controlled clinical studies, recently reviewed by Abramson et al. [5] in a meta-analysis study. The efficacy of the treatment requires certain patient selection criteria, preparation and administration of hyposensitizing extracts. Its efficacy has been confirmed by double-blind clinical trials, reported in a World Health Organization Position Paper [6]. 

The DPDP ligand was synthesized in order to lower the toxicity of the man-ganese(II) ion and to provide selective tissue uptake [40]. The LD50 of an i.v. dose of Mn-DPDP is between 1.9-5.4 mmol kg1 in mice [18, 41]. No mortalities occurred in dogs injected i.v. with 1.8 mmol kg-1 [41]. With the recommended clinical dose of 0.005 mmol kg1, the safety factor for Mn-DPDP is at least 360 [41]. In the European phase III clinical trials adverse events were reported for 46 of 624 patients (7%) [42]. In comparison, 123 of 546 patients (23%) in the U.S. clinical trials reported at least one adverse event [43]. In both trials the most common complaints were headache, vomiting and nausea. In addition, 377 of 546 patients (69%) in the U.S. trials and 26 of 624 patients (4%) in the European trials reported discomfort at the site of injection. The difference between the two trials is likely due to the method of administration and formulation of the Mn-DPDP solution. In the European trials, a 0.010 mM solution of the agent was slowly infused while in the U. S. trials Mn-DPDP was administered as a bolus injection of a 0.050 mM solution. Experiments have demonstrated a lower incidence of adverse events with infusion of the agent [44]. 

Clinical trials report antiplatelet effects following garlic ingestion and mixed effects on fibrinolytic activity. These effects in combination with antioxidant effects and reductions in total cholesterol may be beneficial in patients with atherosclerosis. In preliminary trials involving atherosclerotic patients, significant reductions in plaque volume were observed for patients taking garlic versus placebo. 

Noncompliance reporting Clinical trial reports Training and development... 

Consistency of reports and views of data ontpnt to the screen with clinical trial report tables, listings, and original... 

A meta-analysis of randomized clinical trials reported peak ocular hypotensive effect on lOP of 17% (19% to 15%) and trough effect of 17% (19% to 15%). 

THE CLASSIC COMPONENTS OF A CLINICAL TRIAL REPORT IN A PEER-REVIEWED JOURNAL... 

The classic components of a clinical trial report in a peer-reviewed journal... 

There are a few exceptions to this generalization, however. Legitimate retrospective analysis of the database of a clinical trial that has been previously published in full sometimes can make an isolated abstract, provided the full reference is provided, and an educated audience at, say, an academic conference, will be aware of the potential biases of this technique. Similarly, the open-label tolerability extension to a previously published controlled trial might be usefully published as a poster. But these are minor exceptions to the general principle that in order to assess the validity of a clinical trials report, far more detail is needed than... 

Electronic publishing is relatively new and is not yet in any standardized form. It is important to understand, however, the main classes of electronic publication, before taking the big step of committing your clinical trial report to it. Only then can the central question be answered for that clinical trial Would electronic publication make these data more easily available to the audience that can best use them (Geddes, 1999) ... 

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