Clinical-trial reforms sought

TORONTO — The highly publicized deaths of people in clinical trials has spawned more government oversight of the drug-development business, and one of its prominent regulators said yesterday that more must be done to improve oversight and sustain public trust in medical experiments.

Patient deaths at the University of Pennsylvania, Johns Hopkins and at Seattle's Fred Hutchinson Cancer Research Center in recent years have grabbed attention from media and lawmakers and have spurred moves toward reform.

In one of dozens of panel discussions at the Biotechnology Industry Organization's annual convention, Dr. Greg Koski, director of the federal Office for Human Research Protections, said industry and academic-research centers must reform the way they handle informed consent, conflicts of interest, and independent institutional review of its trials.

"The goal is to prevent harm to people participating in trials because if we don't, we'll find ourselves in a position where people won't participate and that would be devastating," Koski said.

Some work has begun. Koski, who took charge of his office in September 2000, said his budget has nearly tripled, from $2.7 million to $7.8 million, and his staff has grown from 22 to 48. He said his office has about 50 current investigations, but that it is switching from a "reactive" mode of investigating complaints to a more proactive oversight of trials.

The new method will involve surveillance in the form of random inspections at clinical-research sites, videoconferences to review clinical procedures, and numerous phone calls to better educate Institutional Review Boards, which monitor patients' safety.

Koski said the drug industry has been receptive to the new efforts, but some have gone too far and do little — even harmless questionnaires — without approval of a review board.

Koski said he wants to improve knowledge of the rules and to have his office contact all of the nation's 4,000 or so clinical-research sites over the next five years.

Clinical-trial rules need to be simplified, he said, and the procedure for reporting injuries or deaths needs to be clarified.

But Heidi Wagner, director of government affairs for Genentech who chairs an organization committee on human protections, pointed out that none of the highly publicized clinical deaths have occurred in industry-sponsored trials. The industry, she said, is "doing a very good job of protecting folks."

The industry, Wagner said, is confused because it must deal with multiple agencies with different rules and because new rules are making research more cumbersome across state lines.

The industry doesn't want to see a ban on conflicts of interests for physicians conducting a trial, but it does support better disclosure, Wagner said.

Koski and Wagner said medical research has not been hampered by patients being afraid to enroll in trials, and they need to work to keep it that way.

"We need public trust in research trials and for people not to feel like human guinea pigs," Koski said.

Bob Goldberg, director of the Center for Medical Progress at the Manhattan Institute, took umbrage with suspicion about doctors.

"We should not apologize for the role of financial interests in advance of medical progress," Goldberg said. "They are legitimate and here to stay."

Luke Timmerman: 206-464-5644 or ltimmerman@seattletimes.com.