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Expert discusses impact of pharmacist intervention on clinical trial enrollment


In an interview with Pharmacy hours at the 2022 American Society of Clinical Oncology, Beth Koselke, PharmD, BCOP, discussed the impact of pharmacist involvement in clinical trial recruitment, particularly in the MYLUNG Consortium.

Q: Can you explain to us what the MYLUNG Consortium is?

Beth Koselke: The MYLUNG Consortium brings together providers and researchers from the US Oncology Network and US Oncology Research, as well as partners from life sciences and patient advocacy groups. Their goal is to promote advanced non-small cell lung cancer research for patients in the community setting, specifically looking at molecular testing for barriers.

Q: What is the role of pharmacists in the recruitment of clinical trials in general?

Beth Koselke: I think that’s actually a very underutilized part of what pharmacists do. Typically, pharmacists have always been in the investigational drug business where we make sure patients get the right investigational drug once patients are enrolled in studies, but I think pharmacists can really be in the business of selecting patients for trials because we are already looking for patients for appropriate drugs and disease status. We may include inclusion and exclusion criteria in this to screen patients for upstream trials. Maybe when doctors are too overwhelmed and don’t really think about enrolling patients in clinical trials, we’re like another pair of eyes that can help with that.

Q: Can you discuss your study design and objectives?

Beth Koselke: We were integrated into phase 2 of the my lung protocol, there are 3 distinct protocols, and we are in the second protocol. This is an observational study, where we examine the operational feasibility of biomarker testing before patients start treatment. There are 11 open trial sites and pharmacist intervention was conducted at 6 of these sites. We looked at before and after the pharmacist’s intervention, which included a selection of the pharmacist patients, both through a weekly report, as well as through the normal review of chemotherapy orders and then messaging providers and clinical trial staff. We hoped to see an improvement in the number of registrations once the pharmacist’s intervention was completed.

Q: What did you find about the impact of pharmacists?

Beth Koselke: We found that we had nearly doubled enrollment rates at the 6 practice sites we were involved with. We therefore went from an average of 3.4 patients registered per month to 6.6 patients registered per month. In every practice site we touched, we saw an improvement. So I think that’s pretty exciting and shows that a pharmacist can be integrated remotely into community oncology and into the whole network.

Q: How could this information be used in the future, both in the MYLUNG consortium and in other clinical trial programs?

Beth Koselke: I think, as I mentioned earlier, that pharmacists involved in a multidisciplinary research team can really benefit the whole team by looking at patients upfront and earlier. Then, when patients are on second and subsequent lines of treatment, it’s really difficult to catch those patients for clinical trials. Thus, a pharmacist would be an excellent second pair of eyes for this as well as for genomic screening of patients. So we see patients presenting with a mutation and we know we have an open trial there. We would be a very good person to stop before the patient gets a prescription and say they would qualify for an open study there.