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Recordkeeping lags in some Moffitt trials

By WES ALLISON

© St. Petersburg Times, published October 19, 2000


TAMPA -- An independent review of clinical trials at the H. Lee Moffitt Cancer Center found lapses in recordkeeping in a handful of trials, officials said.

The Eastern Cooperative Oncology Group, a coalition of cancer research centers affiliated with the National Cancer Institute, discovered the violations in five of Moffitt's ECOG-sponsored trials during a routine audit three months ago.

The lapses included incomplete data forms and delayed entry into the computer system that keeps tracks of reams of data about each patient in each trial. Moffitt stopped enrolling new patients in those trials, although the trials were allowed to continue with existing patients, Moffitt officials said on Wednesday.

A records infraction may sound "bureaucratic , but it is for a good reason, to protect patients," said Trish Goldsmith, vice president of institutional and business development at Moffitt.

"We're growing here, very rapidly, and the accrual (of patients into studies) is at an all-time high. The data outgrew us a little bit."

Moffitt has 264 clinical trials ongoing. Of those, 66 are sponsored by ECOG, which coordinates studies of new drugs, procedures and other aspects of cancer treatment and research among its members.

Every aspect of a clinical trial is expected to be noted and logged, including the patient's treatments, reactions, test results and overall health. A computer system keeps the data organized so researchers can review it.

Since the oncology group's review, Moffitt has hired extra people to speed up the entry of data, Goldsmith said. Representatives of ECOG returned last week for a follow-up investigation and found the center was adequately addressing the problem, Moffitt officials said.

Moffitt plans to resume enrolling patients in the ECOG trials as soon as it catches up on its records, likely by the first of the year.

Meanwhile, Moffitt and the sponsors of its other trials, which include the federal government and pharmaceutical companies, also have reviewed every other trial this year. Each received a satisfactory rating, Goldsmith said.

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