Authors
Evelyn Crowley, Shaun Treweek, Katie Banister, Suzanne Breeman, Lynda Constable, Seonaidh Cotton, Anne Duncan, Adel El Feky, Heidi Gardner, Kirsteen Goodman, Doris Lanz, Alison McDonald, Emma Ogburn, Kath Starr, Natasha Stevens, Marie Valente, Gordon Fernie
Publication date
2020/12
Journal
Trials
Volume
21
Pages
1-10
Publisher
BioMed Central
Description
Background
Data collection consumes a large proportion of clinical trial resources. Each data item requires time and effort for collection, processing and quality control procedures. In general, more data equals a heavier burden for trial staff and participants. It is also likely to increase costs. Knowing the types of data being collected, and in what proportion, will be helpful to ensure that limited trial resources and participant goodwill are used wisely.
Aim
The aim of this study is to categorise the types of data collected across a broad range of trials and assess what proportion of collected data each category represents.
Methods
We developed a standard operating procedure to categorise data into primary outcome, secondary outcome and 15 other categories. We categorised all variables collected on trial data collection forms from 18, mainly publicly funded, randomised superiority trials, including trials of an …
Total citations
2020202120222023202411352