ArticleSexually transmitted diseases2017
Impact of Eligibility Criteria on Participant Enrollment for a Randomized Clinical Trial of Gonorrhea Treatment.
Article in Sexually transmitted diseases, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Authors and funding
3 authors.
Funding
Abstract
backgroundHigh rates of failure to qualify for clinical trial participation increase time and cost required for study completion. Identification of remediable reasons for prescreen failure can help reduce prescreen failure rates and improve study cost effectiveness.
methodsReasons for prescreen failure to qualify for participation in a phase 2 randomized clinical trial of treatment of uncomplicated urogenital gonorrhea were collected from prescreening logs. Reasons were categorized based on whether the reason was that the subject failed to meet eligibility criteria or declined participation. Subjects who failed prescreening but could have been enrolled under protocol amendments were used to estimate potential cost savings had enrollment completed sooner.
resultsOver 88% (1373/1554) of potential study candidates were not enrolled. The majority (68.8%) of nonenrolled subjects failed prescreening due to not meeting eligibility criteria, whereas 31.0% declined to participate. The most common reasons for failure to qualify were having only nonurogenital gonorrhea (16.4%), limited time (13.1%), and being on antiretroviral therapy (7.5%). Potential cost savings if protocol amendments affecting eligibility had been instituted earlier were estimated at US $127,500.
conclusionsCareful attention to reasons for prescreen failure can inform clinical trial protocol development to address trial design features that may impact successful enrollment. More efficient subject enrollment can result in substantial cost savings.
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