Study Examines Community Pharmacies as Clinical Trial Sites
During the study, which examined the prevalence of penciclovir and acyclovir resistance in patients with recurrent Herpes labialis infection, specially trained community pharmacists collected mouth-area swabs from 1,803 study enrollees.
In all, 1,087 swabs tested positive for herpes simplex 1 (HSV-1) virus, 708 were negative for HSV-1, and five could not be tested. According to the report, the pharmacists' HSV-isolation rate was comparable to that seen in physician-led studies of HSV infection.
The project was sponsored by GlaxoSmithKline and Salt Lake City-based PEGUS Research Inc., a contract research organization that recruits community pharmacies to serve as clinical trial sites for population-based studies. Results of the study were published in the JulyAugust issue of Pharmacoepidemiology and Drug Safety. Virology results were published in an abstract in Antiviral Research.
Volunteers for the study were recruited through advertisements and initially screened over the telephone by nurses. A total of 16,322 potential enrollees were screened, and 2,538 were referred to a participating pharmacy for assessment by a pharmacist.
Pharmacists at each study site were responsible for obtaining informed consent from patients, aseptically collecting viral swabs, storing the specimens, and shipping them to a central laboratory for processing.
The report's authors noted that deviations from the study's protocol were "not uncommon" during the five-month project. Monitoring by the study's sponsors revealed 219 protocol deviations, most of which the authors characterized as "not serious and...amenable to correction with enhanced training, monitoring of performance, and experience."
Failure to properly stage the HSV lesion was the most common deviation from the protocol. Pharmacists who collected samples were instructed to obtain swabs only from study volunteers whose mouth-area lesions were at the vesicle or soft ulcer stage. In 124 cases, pharmacists obtained swabs from patients whose lesions had progressed beyond that stage.
The ability to properly grade HSV lesions varied considerably among the study sites. Pharmacists at 16 of the 47 study sites made no lesion-staging errors. Sixty-five percent of the staging errors occurred at 10 study sites, resulting in one staging error for every eight patients enrolled at these pharmacies.
The report noted that the pharmacists received compensation for each swab obtained but not for screening patients whose lesions did not meet the study's inclusion criteria. Better accuracy during the sample-collection process might have been achieved, the authors suggested, if a "graded compensation plan" that allows some compensation for all screening services had been used.
Other protocol deviations described in the report were pharmacists' failure to properly sign and date informed-consent documents and the enrollment of children under 12 years of age, the study's minimum age for entry. Each study participant made a single visit to the pharmacy, which limited the pharmacist's ability to correct paperwork omissions that were discovered after the visit, according to the report's authors.
The authors speculated that early monitoring for deviations and retraining of pharmacists who had difficulty staging the lesions might have increased adherence to the protocol.