Estimates of treatment effects in randomized controlled trials (RCTs) are comprised
of efficacy and harm outcomes. Similarly, treatment decisions rely on accurate knowledge
of both efficacy and harms. Harms can be measured as pre-specified outcomes and may
be detected through systematic assessment (e.g., checklists or laboratory tests) or
emergent non-anticipated events detected through systematic or non-systematic assessment
(e.g., regular application of questionnaires (systematic) or spontaneous reporting
(non-systematic)) [
[1]
,
- Hodkinson A
- Kirkham JJ
- Tudur-Smith C
- Gamble C
Reporting of harms data in RCTs: a systematic review of empirical assessments against
the CONSORT harms extension.
BMJ Open. 2013; 3 ([published Online First: 2013/10/01])e003436https://doi.org/10.1136/bmjopen-2013-00343610.1136/bmjopen-2013-003436
[2]
. The frequency of harm outcomes detected in RCTs vary depending on how the outcomes
were collected, the frequency of the collection, and also on factors such as the condition
under investigation, the investigational treatment, demographic characteristics of
the participants, and time dependence between treatment implementation and the development
of the adverse event. The many different ways to identify and measure harms in RCTs
generates multitudes of complex data and arbitrary decisions regarding reporting are
often used [
- Zarin DA
- Tse T
- Williams RJ
- Carr S
Trial Reporting in ClinicalTrials.gov - The Final Rule.
N Engl J Med. 2016; 375 ([published Online First: 2016/09/17]): 1998-2004https://doi.org/10.1056/NEJMsr1611785
[3]
]. To compound the problem, clinical trials are typically designed, analyzed and reported
to focus on efficacy outcomes [
[4]
], and harms tend to receive less attention at both the design stage as well as in
reports of published RCTs [
[5]
,
[6]
.Key words
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Article info
Publication history
Published online: May 09, 2021
Accepted:
April 25,
2021
Footnotes
Conflict of interest statement: To the author's knowledge, no conflict of interest, financial or other, exists.
Identification
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