Their task: 'Standardizing everything'

Science Article

Each year, office handles 60 to 70 new protocols, monitors 400 others

The faces of the Hutch Protocol Office (clockwise from left): Terry Morris, protocol specialist; Tod Hagard, program assistant; Rita Bowker, administrative coordinator, and Melody Anderson, Protocol Office manager.

Ever hear of "internal review" at the Hutch? What exactly does it mean, and who handles the task? It's a process in which a clinical scientist's research plan is reviewed and approved by fellow Hutch scientists. It involves dotting every "i," crossing every "t" and being at the right meeting at the right time.

The internal-review process for these clinical-research protocols is so complex that the Clinical Research Division maintains a Protocol Office of five-and-a-half full-time staffers to coordinate all the steps of the scientific side of the review.

Another office, the Institutional Review Office, assists the Institutional Review Board, which handles the ethical issues around the use of human subjects.

The Protocol Office deals with 60-70 new protocols per year and monitors the 400 protocols currently open. The latter involves maintaining a large clinical research database, which makes sure that protocols receive the required annual review.

"The people in the Protocol Office do a huge amount of processing," said Dr. Paul Martin of the Clinical Research Division. "They standardize everything, and without them, the principal investigators would be left to their own devices, which could be incredibly messy."

The Hutch has had a scientific peer-review process since before it officially became the Hutchinson Center, in the form of a weekly graft-vs.-host disease meeting for investigators with an interest in this complication of bone-marrow transplantation. After the opening of the Hutch in 1975, that meeting was opened up to include all investigators in the Clinical Research Division.

Peer review

Scientific peer review ensures that researchers do the best possible work - work that the Hutch, as a whole, will be proud to stand behind. Now, however, the process also exists to meet federal regulatory requirements.

Melody Anderson, manager of the Protocol Office, notes that the National Cancer Institute requires that each comprehensive cancer center conducting clinical studies has an internal review and monitoring system.

The NCI also has established guidelines for that system, prompting the Hutch to expand the focus of the of the clinical investigator meeting to include an advisory role.

The steps involved in the internal review process depend on the nature of the study. However, the principal investigator typically appears in person before a clinical investigators' meeting to present and answer questions about the proposed protocol. The meeting is made up of members of the Center's faculty, who, in a confidential ballot, rate the protocol for scientific merit and priority compared to other studies of the same disease.

The Scientific Review Committee, established during the 1996 restructuring, then reviews the protocol, assessing results of the meeting in making a final decision.

Approved protocols are submitted to the Protocol Implementation Committee, which considers the feasibility of implementation.

Finally, following any modifications, the division director and a statistician must sign off on the protocol, after which it's submitted to the Institutional Review Office for review of ethical issues by the Institutional Review Board.

Anderson said the process used to take about 12 weeks. Thanks to streamlining of procedures in August, it now generally takes about eight weeks.

However, in an emergency situation - if patients are waiting for a new protocol or modification of an existing protocol - "we'll do whatever we can to make it happen more quickly, in as little as 24 hours."

Most of the Center's clinical research protocols ultimately pass internal review, although they may be changed significantly along the way. Anderson said only 5-8 percent end up "no go," or about two of the 60-70 submitted each year.

Of course, initial approval does not mean the protocol is home-free forever

Enrollment tracking

Using its database, the Protocol Office tracks whether participants are being enrolled at the rate projected and what, if any, adverse events occur. And it makes sure that every study receives an annual continuation review, which involves the Protocol Data Monitoring Committee, established during the 1996 restructuring.

Although the Protocol Office primarily handles internal scientific review for the Clinical Research Division, it also coordinates review for some Public Health Sciences Division studies and, since 1999, for all Puget Sound Oncology Consortium studies.

Anderson has worked in the Protocol Office for 10 years, during which time it grew by three and a half positions from a staff of two.

In the early years, she said, the office was on the same floor as the Center's patients.

"It was gratifying to be reminded every day that what you were doing made a difference for patients who came to the Center for treatment," she said.

"There's more detail in the process now, and less patient contact, but you can still remember: 'This isn't just a piece of paper, it's somebody's treatment - and their life.' "

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