Strategies implemented for accurate dispensing of an investigational new drug in a multi-site HIV prevention clinical trial

Safe practices for dispensing investigational product (IP) during clinical trials are not standardized and information in this regard is often limited. ASPIRE was a Phase 3 safety and effectiveness trial of a vaginal matrix ring containing 25 mg of dapivirine for the prevention of HIV-1 in women. Th...

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Bibliographic Details
Published in:	Contemporary clinical trials communications Vol. 24; p. 100859
Main Authors:	Jacobson, Cindy, Moodley, Jayajothi, Bhoola, Aruna, Sakwa, Rebecca, Moodley, Jeeva, Sukdao, Jasmin, Hurbans, Nivriti, Maharaj, Bhavna, Naidoo, Anushka, Maclachlan, Melanie, Chareka, Gift, Hlahla, Kudzai, Chadza, Mary
Format:	Journal Article
Language:	English
Published:	Netherlands Elsevier Inc 01-12-2021 Elsevier
Subjects:	Dispensing errors Investigational product Pharmacy Quality checks Investigational product Quality checks GCP Pharmacy IP SOPs Dispensing errors PTID NCR ICH ICH, International Council for Harmonisation SOPs, Standard Operating Procedures GCP, Good Clinical Practice IP, Investigational Product PTID, Participant Identification NCR, No-carbon required
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Summary:	Safe practices for dispensing investigational product (IP) during clinical trials are not standardized and information in this regard is often limited. ASPIRE was a Phase 3 safety and effectiveness trial of a vaginal matrix ring containing 25 mg of dapivirine for the prevention of HIV-1 in women. The study enrolled 2629 women at 15 clinical research sites in Malawi, Uganda, South Africa and Zimbabwe who were randomized in a 1:1 ratio to receive either a vaginal ring containing 25 mg of dapivirine or a matching placebo vaginal ring. The vaginal rings and packaging were identical in appearance in order to maintain the study blind. A real-time, documented second check of the dispensing process was conducted by a second pharmacy staff. Frequent inventory counts and real time accountability audits were also useful for rapidly identifying a dispensing error. A total of 52,625 vaginal rings were dispensed with only three documented pharmacy dispensing errors. There were zero dispensing errors at 13 of the 15 sites with an overall rate of <1.0 per 10,000 rings dispensed. Our study findings support the implementation of a double check dispensing process and real time accountability audits as standard practice in clinical trials.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	2451-8654 2451-8654
DOI:	10.1016/j.conctc.2021.100859