Impact of Eligibility Criteria on Participant Enrollment for a Randomized Clinical Trial of Gonorrhea Treatment.

ABSTRACT:

Background

High 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.

Methods

Reasons 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.

Results

Ove

SUBMITTER: Long JE 

PROVIDER: S-EPMC5431289 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature