More than 95% of respondents in a recent survey said they were more comfortable participating in a clinical trial knowing that a pharmacist was on call to answer questions, says Gerald Finken, a registered pharmacist since 1982. “A majority of patients have significant questions which, if not addressed in a timely manner, can adversely impact the clinical efficacy and health outcomes of a study,” Finken adds.
The survey analyzed 17 clinical trials with a focus on observing high-, medium-, and low-impact interventions by pharmacists. Key findings include:
- More than 27,000 pharmacist calls were made to 3,874 trial participants.
- In four trials for one chronic disease medication, more than 92% of patients had at least one intervention.
- Nearly half of clinical patient calls to the pharmacist had at least one intervention.
- The majority of interventions involved concurrent medications, side effects, and interactive voice response systems used by trial managers for communication with patients.
Finken, who has worked in the clinical supply chain for 34 years with chain and community pharmacies, independent hospital pharmacies, and a VA hospital pharmacy, suggests usage of apps and wearable devices in trials has supplanted pharmacist involvement in too many cases. “Have we lost focus on ‘human connections’ by the great marketing campaigns of technology?” Finken asks. Perhaps, but it doesn’t appear that interest in that kind of technology is going to wane anytime soon. For example, global shipments of wearable medical devices will surpass 106 million in 2016, according to a study by Future Market Insights. That’s up nearly 5% from 2015.
Finken suggests that data from a Tufts Center for the Study of Drug Development report show there is a problem:
- In 1980, approximately 10% of New Molecular Entities (NMEs) made it the whole way from Phase I trials to New Drug Application (NDA) approval on the first try by the U.S. Food and Drug Administration at a cost of some $500 million.
- In 2015 under the same scenario, it was again approximately 10% of NMEs reaching NDA approval by the agency. The cost this time? Approximately $2.5 billion.
If this isn’t addressed, Finken predicts it will cost $3 billion to approve 10% of NDAs in 2020.