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

Long, Jill E. MD, MPH, MHS*; Wierzbicki, Michael R. PhD; Hook, Edward W. III MD

Sexually Transmitted Diseases: June 2017 - Volume 44 - Issue 6 - p 362–364
doi: 10.1097/OLQ.0000000000000604
Original Studies

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: Over 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.

Conclusions: Careful 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.

Gonorrhea treatment found that 88% of potential study candidates failed to qualify.

From the *National Institute of Allergy and Infectious Diseases, Bethesda, MD; †The Emmes Corporation, Rockville, MD; and ‡Department of Medicine, University of Alabama at Birmingham, Birmingham, AL

Acknowledgements: The authors would like to thank Shacondra Johnson from FHI 360 for her assistance with data reports for this study, and Peter Wolff and Carolyn Deal from the National Institute of Allergy and Infectious Diseases for their support and guidance through development, analysis, and reporting of this study.

Conflict of interest and sources of funding: none declared.

Correspondence: Jill Long, MD, MPH, MHS, National Institute of Allergy and Infectious Diseases, 5601 Fishers Lane Room 8E45, Rockville, MD 20892-9825. E-mail:

Received for publication September 7, 2016, and accepted January 31, 2017.

© Copyright 2017 American Sexually Transmitted Diseases Association