Approximately 5% of atopic eczema trials are terminated and the overall discontinuation rate is 14%, according to cross-sectional analysis data published in the British Journal of Dermatology.
Researchers sought to determine the percentage of trials registered on ClinicalTrials.gov for atopic eczema that were discontinued, the reasons for discontinuation, and whether the results were published if recruitment had begun. Trial status was considered discontinued if the trial: (1) commenced recruitment, enrolling patients, but later discontinued (“terminated”); (2) discontinued before commencing recruitment (“withdrawn”); and (3) were active but had not updated the study record for 2 or more years (“unknown”). The researchers identified 653 trials, of which 90 (13.8%) were discontinued: 35 (5.4%) terminated, 27 (4.1%) withdrawn, and 30 (4.6%) unknown. In most cases, discontinuation appeared avoidable and the most common reasons for discontinuation were recruitment-related or sponsor decision. In trials that commenced recruitment, 48% did not publish results.
Although this study provides the first assessment of trial discontinuation in atopic eczema, a limitation is that because only atopic eczema trials were searched the study “is not fully representative of the clinical trial landscape,” the investigators noted.
The authors concluded that, “Terminating trials prematurely, without a valid or stated reason, is ethically unfair to patients who willingly take part and who may be exposed to risk through participation.” They added that, “When a trial is discontinued, the reason for this and any results obtained should be disclosed in order to [maximize] the study’s societal value and reduce publication bias.”
Steele L, Flohr C. The prevalence of and reasons for discontinuation of atopic eczema trials on ClinicalTrials.gov: a cross‐sectional analysis [published online January 6, 2020]. Br J Dermatol. doi:10.1111/bjd.18858