Shared Resource: Investigational Chemotherapy Service Lab

July 7, 2015
By: William Alexander, Writer, DCI

Cheryl Morgan-Maxey, clinical research coordinator, and Martin Kowalsky, PharmD, are members of the Investigational Chemotherapy Service. The service ensures that patients enrolled in clinical trials receive customized medications meeting stringent guidelines outlined by the FDA and the Cancer Therapy Evaluation Program.The Investigational Chemotherapy Service is one of two labs making up the Pharmaceutical Shared Resource. 

Putting a new cancer medication through the early stages of clinical trials is an intimidatingly complex process. A proper dosage regimen must be tailored for every patient. Medications may need to be mixed into a solution at a specific ratio, kept at certain temperature until just before use, or prepared according to other instructions, while meeting FDA and Cancer Therapy Evaluation Program guidelines. Medications may be given orally, through an IV line, subcutaneously, or through other means.

Finally, each medication--and some clinical trials involve multiple medications per person—often must be prepared in a manner that allows the information to be recorded for research purposes but does not give away the study drug assignment to the patient or the administering provider (doing so could lead to accidental bias and damage the validity of the trial).

Beth McLendon-Avrik, PharmD, manager ICS/IDS, consults with colleague Martin Kowalsky, PharmD.Multiply this task for hundreds of clinical patients participating in the hundreds of early-stage clinical trials at the Duke Cancer Institute, and you have the job of the Investigational Chemotherapy Service (ICS), one half of the Pharmaceutical shared resource.

“The clinical pharmacy services we offer help to both provide safety and maintain the integrity of research studies at the DCI,” said Beth McLendon-Arvik, PharmD, manager of the ICS. “We prepare investigational drug products, maintain drug accountability records and investigational drug inventories according to guidelines, and also provide design consultation, professional staff education, and implementation services for clinical research studies,” McLendon-Arvik said.

Paul Bush, PharmD, MBA, is director of the ICS, which is located in the ambulatory Duke Cancer Center Building. In addition to Bush and McLendon-Arvik the ICS is staffed by a clinical pharmacist, Martin Kowalsky, PharmD, a clinical research coordinator, Cheryl Morgan Maxey, and a clinical research specialist, Bo Morrissey.

At any given moment, the ICS typically has 215 to 230 active study protocols. In 2014, the ICS prepared more than 5,000 individual treatment regimens for almost 700 patients.

Peggy Alton, RN, a clinical research nurse coordinator within the Department of Cellular Therapies, which relies on the ICS for studies involving acute and chronic leukemia, myelodysplastic syndrome, lymphomas, and multiple myelomas. Alton is currently is overseeing a phase-II clinical trial for leukemia that will examine whether a new treatment will keep patients in remission longer than the standard forms of care.

“Our job is not only possible because of the ICS, but it’s a lot easier, too,” Alton said. “They’re a great group to work with. Thanks to them there’s a lot I don’t have to worry about.”

Visit the Pharmaceutical Research shared resource's webpage, or read about the PK/PD Core lab, the ICS's sister lab.

circle photo: Paul Bush, PharmD, MBA, BCPS, FASHP, chief pharmacy officer and co-director of ICS/IDS, poses with his team: Cheryl Morgan-Maxey, clinical research coordinator; Martin Kowalsky, PharmD; William "Bo" Morrissey, clinical research specialist; and Beth McLendon-Arvik, PharmD, Manager ICS/IDS.