Clinical study reports of randomised controlled trials: an exploratory review of previously confidential industry reports.

ABSTRACT:

Objective

To explore the structure and content of a non-random sample of clinical study reports (CSRs) to guide clinicians and systematic reviewers.

Search strategy

We searched public sources and lodged Freedom of Information requests for previously confidential CSRs primarily written by the industry for regulators.

Selection criteria

CSRs reporting sufficient information for extraction ('adequate').

Primary outcome measures

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).

Data extraction

Data were extracted on standard forms and crosschecked for accuracy.

Results

We assembled a population of 78 CSRs (coverin

SUBMITTER: Doshi P 

PROVIDER: S-EPMC3586134 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature