Premier Clinical Research expands ‘overnight’
Planned studies to require patients to sleep on siteSeptember 14th, 2017
Spokane-based independent pharmaceutical research company Premier Clinical Research LLC has expanded its facility to include an overnight living space, which will enhance its study capabilities here, says Jill Ciccarello, Premier’s director of research.
Premier, which provides four standard phases of clinical drug and device development for the biopharmaceutical industry, is an affiliate of Dr. W. Phillip Werschler’s longtime Spokane Dermatology Clinic PS.
Premier occupies a 5,800-square-foot space in the Sherman Medical Plaza, at 324 S. Sherman, that includes offices, exam rooms, a lab, a specially designed room to test lung function of study subjects with asthma, and the new overnight space.
Ciccarello says the new space originally was reserved for additional offices or exam rooms, but researchers decided an overnight unit was needed more.
“Certain types of studies require an overnight stay,” she says. “This space will help us to further our capabilities to study things like sleep disorders and certain neurological conditions.”
The 2,500-square-foot overnight space is located in the northwest corner of the building’s second floor and includes a nurse’s station, a kitchen, common space, and five patient bedrooms.
Ciccarello says several overnight studies already have been scheduled to take place there in the coming months.
Premier Clinical Research has 34 employees and six partner physicians, also known as principal investigators, in addition to Werschler.
The principal investigators include Dr. Gary Gleason, of Spokane Dermatology Clinic; Dr. Daniel Coulston, of Deaconess Hospital; Dr. Jason Aldred, of Northwest Neurological, PLLC. Drs. Randall Espinosa, Scott Schade, and Richard Gower also serve as principal investigators, although they are all retired physicians and no longer affiliated with practices.
“It’s very helpful in a research setting to have a team with such varied backgrounds, knowledge, and continuing passion for this work,” says Ciccarello.
Premier has 40 active clinical trials and is in the process of enrolling subjects for 26 more, she says.
“We used to have over 100 active trials, but we’ve been working to condense things,” she says. “Our hope with any study is that the data collected will lead to better treatments for various conditions, and better outcomes for patients.”
She says Premier’s current research studies dermatology, neurology, infectious disease, asthma, orthopedics, women’s health, and diabetes.
“Orthopedics is our newest department,” she says. “We’re still working on further development of that research team.”
Ciccarello says on average, each clinical trial at Premier Research Clinic has 10 to 15 subjects. She says most studies are conducted through multiple research centers and are commissioned by drug and device companies.
Ciccarello declines to disclose Premier’s annual revenues. “Most of our studies are sponsor-initiated, but we’re interested in pursuing more physician investigator-initiated research,” she says. “There are a lot of doctors with great ideas who just need help developing the necessary protocols to create a study, and we have the capacity here to help them do that.”
Ciccarello says physician-initiated studies tend to have a more specific focus than sponsor-funded studies.
“These studies are usually more specific to that physician’s area of study, addressing a need within that community, or a deficiency in scientific knowledge,” she says. “We like to support those initiatives, helping researchers navigate the process of creating a proposal, developing protocols, and seeking funding for their ideas.”
As Ciccarello explains, all clinical trials are conducted in phases that build upon one another. Each phase is designed to answer certain questions about a drug or a treatment.
Phase I trials look into the safety and side effects of a new drug, while Phase II trials determines the effectiveness of the drug under a range of doses. Phase III trials usually involve larger pools of participants who help determine if the drug is effective for the proposed treatment.
After a product initially is approved for marketing, Phase IV studies gather long-term data regarding its safety, effectiveness, and best use.
While most of Premier’s clinical trials are either Phase II or Phase III trials, Ciccarello says Premier also occasionally conducts Phase I trials.
“Previously, we’ve had to turn down a lot of Phase I trials, because they frequently involve overnight stays,” she says. “So the new overnight unit will also allow us to accept more Phase I studies.”
She says each trial comes with its own protocols and staff assigned to track both data and study subjects.
“The only way we learn and develop new treatments is through study and innovation,” Ciccarello says. “Most of the subjects we have are interested in participating because they’re affected by the conditions we’re researching, so we do have a smaller amount of participation here than you might see in a larger city.”
Ciccarello says many people are still afraid of participating in medical research, mistakenly thinking research subjects are treated as guinea pigs.
“We’re working hard to change that perception by educating the community on the ways in which medical research also improves patient care and quality of life,” she says. “We’re always very mindful of the studies we take on. These participants are our neighbors, friends, and family, so we take extra care in making sure our work is scientifically sound, ethical, and respectful.”
Ciccarello says Premier’s studies also are meant to bring hope to patients with progressive diseases, such as cancer and Parkinson’s, who might feel they’ve run out of treatment options.
“For some subjects, studies provide another possibility for a positive outcome, and that helps to give them hope,” she says.
Dr. Jason Aldred, who has been working with Premier since 2015, is in charge of the Parkinson’s disease trials at the facility.
He says when companies like Premier are able to complete early Phase I trials, particularly for degenerative diseases like Parkinson’s, it gives sponsors the confidence to continue testing through Phases II, III, and IV.
“When they’re able to see we can offer the full spectrum of development, it helps to facilitate continued investment,” he says. “Having this facility adds to our capabilities, as well as what we’re able to offer this community.”
Aldred says he agrees with Ciccarello that perceptions of medical research here are changing.
“I think for a long time people were surprised to learn about Premier, and that we’re a facility that’s capable of completing high-end research trials right here in Spokane,” he says. “I think perceptions will continue to change as more study subjects continue to have positive experiences.”
Ciccarello holds a bachelor’s degree in psychology from the University of Washington and has been working with Premier for seven months. Her background in biomedical research stretches back over 15 years, and includes work with several Department of Defense programs, as well as Providence Spokane Cardiology, and Charles River Clinical Services Northwest of Tacoma.
In addition to Premier Clinical and Spokane Dermatology, the 20,800-square-foot Sherman Medical Plaza also houses 3rd & Sherman Allergy, an affiliate of the dermatology clinic.
Another affiliate, Werschler Aesthetics, within the building offers advanced skin care and cosmetic treatments, such as Botox and laser procedures.
Ciccarello says the three affiliates have about 75 employees combined.
Werschler estimates Premier accounts for 50 percent of combined revenue for the affiliated operations, and Spokane Dermatology Clinic and Werschler Aesthetics bring in about 30 percent and 20 percent respectively.