MEDICAL : St. Joseph Signs Contract to Permit Staff Doctors to Conduct Drug Tests

Doctors on the staff of St. Joseph Hospital in Orange may soon have an opportunity to conduct tests of new drugs on patients under a contract the hospital has signed with the Institute for Biological Research and Development in Newport Beach.

In the past, participation in such tests has been more readily available to physicians at teaching and research hospitals than to physicians at community hospitals such as St. Joseph.

Roland A. Sauer, executive director and general manager of biological development services at IBRD, said his company, which helps pharmaceutical firms arrange clinical trials for new drugs, generally has recruited large doctor groups who conduct the tests outside a hospital.

He said the company wants to start testing certain drugs, including antibiotics, analgesics and anesthesia, in hospital settings. Sauer said IBRD hopes to set up a prototype testing program at St. Joseph’s that can be duplicated at other community hospitals throughout the country.

Sauer said IBRD will train the hospital staff in testing protocol and reporting standards required by the U.S. Food and Drug Administration, which reviews clinical test results to determine whether new drugs are effective and safe enough for national marketing.

The hospital will be reimbursed the cost of the tests, and the physicians will be paid for their time.

Walter W. Noce Jr., president and chief executive officer of St. Joseph Hospital, said IBRD expects to reach an agreement with a pharmaceutical company to conduct an inpatient drug trial at St. Joseph by the fall.

Meanwhile, Noce said, doctors on the St. Joseph staff have entered separate agreements with IBRD to test several drugs on an outpatient basis for a fee.

Noce said the primary reason the hospital formed a relationship with IBRD is to provide new scientific challenges to St. Joseph’s doctors. He said it will give the doctors the satisfaction of playing a part in developing drugs on the cutting edge of medicine.

Noce said the hospital will test only those drugs that have reached the third stage of FDA clinical trials, when safety risks have been greatly reduced. Nonetheless, he said, all patients who participate in the studies will be required to sign informed consent forms.