Access to unpublished protocols and statistical analysis plans of randomised trials.

ABSTRACT:

Background

Access to protocols and statistical analysis plans (SAPs) increases the transparency of randomised trial by allowing readers to identify and interpret unplanned changes to study methods, however they are often not made publicly available. We sought to determine how often study investigators would share unavailable documents upon request.

Methods

We used trials from two previously identified cohorts (cohort 1: 101 trials published in high impact factor journals between January and April of 2018; cohort 2: 100 trials published in June 2018 in journals indexed in PubMed) to determine whether study investigators would share unavailable protocols/SAPs upon request. We emailed corresponding authors of trials with no publicly available protocol or SAP up to four times.

SUBMITTER: Campbell D 

PROVIDER: S-EPMC9387046 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature