Pharmacist interventions in clinical trials of two major diabetes drugs resulted in more reliable outcomes for the trials, according to a recent study.
The first study of its kind examining the impact of pharmacists on the outcomes of clinical trial was published in the April 2017 issue of Clinical Therapeutics.
“Pharmacists were able to identify, support, and address multiple types of interventions related to medication management during clinical trials, including those related to concurrent medication use, adverse events, and other medication-related issues,” wrote Joe Martinez, RPh, former CEO of Center Point Clinical Services and now a consultant in drug development, market access, and commercialization. “These pharmacist interventions can result in better patient outcomes and, ultimately, more reliable study results for review and approval by regulatory agencies.”
The study involved clinical trials by a major pharmaceutical manufacturer that was investigating two noninsulin, glucose-lowering (NIGLM) diabetes medications administered subcutaneously. The names of the drugs were not revealed.
In some cases, the therapies caused adverse effects—such as nausea and injection site reactions—that contributed to decreased patient adherence and increased patient retention challenges in previous trials, according to Martinez.
Pharmacists called each of the clinical trial participants at specific time points during the trials, totaling 25,829 calls. “The purpose of the pharmacist calls was to educate patients about the study medication and to reinforce protocol instructions. Pharmacists were also available 24 hours a day, 7 days a week to receive patient calls for most trials,” Martinez wrote.
More than 45% of the phone calls resulted in at least one intervention. The most frequent interventions addressed issues with adverse events (14.6%), followed by protocol violations for medication use (12.9%), concurrent medications (5.9%), and miscellaneous concerns (4.6%).
The greatest numbers of interventions were considered to be of high-impact (18.5%), such as for serious adverse events that would seriously affect trial outcomes and patient adherence, according to Martinez.
“From my experience, I believe the pharmacist is the medication expert and this knowledge and experience would yield valuable interventions and outcomes in most clinical trials,” Martinez told Drug Topics. “Many times, the pharmacist is not included in the clinical trial health-care team, or is only positioned to provide ancillary support and medication dispensing only.”
The importance of pharmacist interventions in clinical trials is that “robust, accurate and unbiased clinical data may be collected to accurately reflect the efficacy and utility of the drug,” Martinez said. “One of the questions that should be asked is, ‘Does the drug fail the clinical trial, or does the clinical trial fail the drug?’ Patients’ lack of knowledge may subsequently lead to behaviors that contribute to noncompliance and even dropping out of studies.”
While drug manufacturers may have incremental costs when using pharmacists in clinical trials, they are quickly recouped with the increases in patient compliance, retention, and timely study completion, according to Martinez.
“I believe that the pharmacist should be an integral part of the clinical trial health-care team, in order for patients to have access to medications faster and at less cost,” Martinez said.