The backbone of research trials

Science Article
October 17, 2002

New office corrals, enhances myriad services to help investigators launch and run greater breadth of clinical, prevention studies

Dave Rudig likens the new Research Trials Office, for which he is administrator, to a group of "consultants to make the researchers' jobs easier." Photo by Todd McNaught

By BARBARA BERG

At first glance, you won't see it. But peer closely at the Public Health Sciences construction site and you'll soon become aware of a backdrop synergy of plumbers, metal workers and other subcontractors who are making the new building rise.

So, too, does a cancer treatment or prevention strategy hinge on behind-the-scenes collaboration. While doctors and nurses join forces at the bedside, a less visible but equally indispensable backbone of statisticians, database managers, regulators and other experts works toward a life-saving outcome.

This team is embodied in a new entity known as the Research Trials Office.

And not surprisingly, teamwork in research is its motto, as it aims to give investigators at Fred Hutchinson, the University of Washington and Children's Hospital and Regional Medical Center a comprehensive array of services to support the set-up and conduct of clinical trials.

Critical backup

The office offers study management and statistical expertise, database management, scientific review and monitoring, regulatory-compliance support and other critical backup, said Dave Rudig, the office's administrator.

"In a sense, we are consultants to make the researchers' jobs easier, so they can focus on their research," he said. "We'd like for investigators to think of our staff as members of their team."

Formed in March and still evolving, the office oversees existing clinical-trials support services and several new ones. In addition, the office will set up a program to enhance efforts to comply with the ever-changing provisos of federal funding agencies and the Food and Drug Administration.

The institutions whose procedures the office coordinates - Fred Hutchinson, the UW and Children's - are the partners that comprise both the Seattle Cancer Care Alliance and the Cancer Consortium, a research collaboration based on the Cancer Center Support (core) Grant submitted last fall to the National Cancer Institute.

As an NCI-designated comprehensive cancer center, the consortium must meet rules new to UW and Children's researchers. And because the consortium aims to boost the number of treatment and prevention trials and expand the diseases it treats, investigators at the three institutions need beefed-up and consistently delivered services.

A committee of Fred Hutchinson, UW and Children's representatives will oversee the office. Besides Rudig, its staff includes Dr. Jerry Radich of the Clinical Research Division, acting medical director until a permanent one is hired.

Rudig, who spent 10 years managing financial and information services at Children's, said the office offers expertise, guidance and support to researchers as they conduct human-subjects trials.

Menu of services

"We offer a menu of services, some of which are required by regulatory agencies and others that are optional but may be useful," he said.

For example, a researcher with limited experience in launching a clinical trial might want training and staff to develop and run a protocol, submit regulatory documents and develop budgets, while a more seasoned investigator might not need such help.

Dr. Fred Appelbaum, director of the Clinical Research Division and the Alliance, expects the office to free up crucial time for investigators.

"We want to make it faster and easier for investigators to initiate and conduct clinical trials while assuring ourselves that we are fully complying with expanding rules that govern human-subject protection," he said. "By creating this office, we hope to provide expertise and support so investigators can focus more on the difficult-enough problems of patient care and research."

Top priorities for the office in the coming months are to develop a regulatory-compliance service and implement, by next January, a scientific-review process for solid-tumor and pediatric oncology trials. Down the road, the office will delve into improving efficiency.

Directly and via Internet

Rudig said investigators will use the office directly and via the Internet.

"We have many opportunities to streamline workflow by using technology," he said. "Ultimately, our Web site will let investigators initiate a protocol online and follow it through the review and approval process, as well as provide access to a central tracking system to accrue patients on protocols."

Established services will support more solid-tumor trials and public-health prevention studies.

"For example, Clinical Information already provides database support for collecting participant information and data extraction," he said. "Researchers have used this service mainly to support bone-marrow and stem-cell transplant trials.

"To accommodate solid-tumor trials, we'll build an architecture with common data elements as a baseline, with disease-specific data layered in. This model will provide a robust database to meet researchers' needs and provide secure data sharing and centralized system support. A key element is that it will adapt to fit differing needs."

The office is working on database models for breast and prostate-cancer research, and other cancer types will follow.

Rudig expects the office will pay off in many ways for investigators, patients and participants.

"We want to increase the number of investigator-initiated trials, increase accrual rates, simplify the process for researchers and enhance our commitment to patient protections and regulatory compliance. It will be a success if we make the process easier and less complex."

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