Description: This dataset (data extraction spreadsheet) is associated with an exploratory evaluation of pharmaceutical industry clinical study reports (CSR) for possible use in evidence synthesis and systematic reviews. 78 CSRs from public sources were selected for data extraction. The report dates range from 1991 through 2011, inclusive, and represent 90 randomized controlled trials of 14 pharmaceuticals. The primary outcome measures include presence and length of essential elements of trial design and reporting and compression factor (ratio of page length for CSRs compared to its published counterpart in a scientific journal). The dataset is comprised of an audited table of extracted and derived variables the details for which are described in an accompanying readme file. The uncorrected (original) and corrected extraction sheets as well as audit records are available upon request from Peter Doshi, corresponding author (pdoshi@rx.umaryland.edu).

Subject Domain

Keywords

Access via Dryad
Dataset and readme file
Access Restrictions: Unrestricted access
Access Instructions: Available to download from the Dryad site
Associated Publications: Doshi P, Jefferson T (2013) Clinical study reports of randomised controlled trials: an exploratory review of previously confidential industry reports. BMJ Open 3(2): e002496. http://dx.doi.org/10.1136/bmjopen-2012-002496
Data Type: Administrative
Software Used: Microsoft Excel
Spreadsheet software

Microsoft Word
Word processing software
Dataset Format(s): Microsoft Excel
Dataset Size: 95.98Kb

UMB Data Catalog

Dataset (data extraction spreadsheet) of an Exploratory Review of Clinical Study Reports of Randomised Controlled Trials
UMB Dataset