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    MARCH 23, 2006
 
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Medical research at Temple seeing big growth

clinicaltrial
Jesse Goldman (right), director of peritoneal dialysis and assistant professor of medicine at the School of Medicine and Temple University Hospital, talks with Warren Bryant (left), a study participant in a clinical research trial of an experimental drug to treat anemia in hemodialysis patients.

Recently, newspapers hailed the approval of inhalable insulin, which will potentially save millions of diabetics from having to self-inject. Like all new drugs and medical devices, inhalable insulin underwent years of research, first in the lab and then in humans, to determine that it was safe and that it actually worked.

Human studies of experimental devices and medicines like this are known as clinical trials.

To conduct clinical trials, the pharmaceutical, biotechnology and medical device industries rely on academic medicine, where they can partner with physician scientists and reach patients interested in experimental treatments.

Recently, thanks to growth in research activity and expertise, industry has been turning more frequently to Temple.

This year, the number of clinical research trials at Temple is expected to increase by 50 percent.

In the 1970s and into the mid-1980s, Temple was a vital national research university — ranking among the top 100 institutions in the United States.

But during the 1990s, Temple’s research program declined sharply and today ranks 133rd out of 599 schools.

Significant effort has since been made to reverse this trend, a top priority of the University administration.

Temple is spending millions of dollars to construct and renovate research labs, and will break ground on a new Medical School building this year (see “New clinical research facilities”).

Nationally known scientists have been recruited to complement the existing core of Temple researchers.

But most importantly, a central office dedicated to supporting clinical research trials was formed: the Office of Clinical Trials.

The OCT, part of the Office of the Vice President for Research and Graduate Studies, is headquartered at the Health Sciences Center, where it’s surrounded by the Hospital and Temple’s health/science schools — Dentistry, Health Professions, Medicine, Pharmacy and Podiatric Medicine — a location ripe for discovery.

Opened in 2002, the office handles all industry-sponsored clinical trials research and offers support services to clinical trials research funded by the federal government or private foundations.

New clinical research facilities
• New $150 million, 458,000-square-foot Medical School with state-of-the-art research space
• Renovation of existing scientific laboratories
• New Center for Bioanalysis and Pharmacokinetics at the School of Pharmacy
• New drug manufacturing facility at the School of Pharmacy

“Our first goal was to build the right infrastructure, so that we could start trials in a timely manner,” said John Aybar, director of the OCT.

So far, the office has reduced the time it takes to start a clinical trial at Temple by 25 percent, with a goal to reduce it by another 25 percent.

Critical to a strong research infrastructure is a standardized, simplified process by which to initiate and run clinical trials.

To this end, Arleen Wallen and two clinical trials project assistants serve as a dedicated point of contact for both faculty and industry, managing budgets and contract negotiations, establishing master agreements, facilitating regulatory procedures and tracking the progress of each trial.

“Time is of the essence in many ways, and the OCT has streamlined the entire clinical trials process,” said Kenneth J. Soprano, vice president for research and graduate studies.

“Industry watches how quickly we can put together a contract. And if they believe we can get the job done well, they’re more likely to work with us again.”

Craig Pfister, program manager in the OCT who joined Temple from GlaxoSmithKline pharmaceuticals, works with faculty, research nurses and industry representatives to identify trials that match the University’s existing strengths, as well as opportunities for those new to or building their clinical trials research.

So far, three schools are running clinical trials: the College of Health Professions, the School of Medicine and the School of Podiatric Medicine.

The department of medicine at the School of Medicine, a longtime clinical trials research powerhouse, particularly in pulmonary, cardiology and gastroenterology, uses OCT support to build on its success.

Other clinical trials research programs, including HIV/AIDS, pediatrics, orthopedics, nephrology and rheumatology, have successfully built momentum through working with the OCT.

In the past year, for example, pediatrics, chaired by Stephen Aronoff, began five new clinical trials and is planning another six. Industry sponsors have been impressed by the department’s performance.

In one multi-center trial, Temple Children’s was the first hospital ready to enroll study participants, and in another, was the first to meet enrollment goals.

Orthopedics, chaired by Joseph Thoder, also has rapidly expanded its clinical trials program, attracting numerous industry sponsors who want to collaborate.

The department initiated six new clinical trials last year, two of which involve other School of Medicine departments, anesthesia and vascular surgery (see “Orthopedic surgery research”).

New faculty member Pekka Mooar, who directs orthopedic surgery clinical trials, attributes the success to the department’s large and diverse patient base, which spans three hospitals, including Temple University Hospital.

Each year, orthopedics handles 1,000 surgeries and 10,000 patient visits.

Modern facilities, expert researchers and a strong infrastructure are imperative. But one more element is vital to a successful research university.

Orthopedic surgery research
Studies
• New medication and physical therapy program to prevent loss of muscle mass and strength after surgery to repair hip fracture
• Investigational solution used during arthroscopic surgery to block pain and inflammation caused by anterior cruciate ligament reconstruction
• Investigational medication to reduce healing time from tibia shaft fixation surgery
• A study to validate and evaluate the benefits of the use of reconditioned saw blades in the operating room

Collaborations
• With vascular surgery, a new medication to prevent deep vein thromboembolism in patients undergoing total knee replacement surgery
• With anesthesia, the use of nerve blocks to prevent post-operative pain in patients undergoing arthroscopic shoulder surgery

“We’re focused on conducting strong, ethical research,” Aybar said. “Reputation is everything, and with industry it’s very tenuous. If you stumble, they remember.”

To monitor and ensure the quality of research on human subjects at Temple, all clinical trials undergo a rigorous review by the institutional review board or IRB.

Comprising Temple faculty, faculty from other universities and community members, it is and chaired by Michael Jacobs, professor and chair of pharmacy practice at the School of Pharmacy.

The OCT guides faculty and industry through the entire IRB process, which is subject to monitoring by federal regulators.

“There are so many good reasons to be involved in clinical trials,” Soprano said.

As an academic medical center, we want to be on the cutting edge of medical knowledge.

Patients who come to us should have access to the latest treatments, including the experimental ones.

It’s what makes places like Fox Chase and Sloan-Kettering so great, and we want to offer the same advantages to our community.”

 

 

 

 

- By Eryn Jelesiewicz

 

 


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