NCI Explores Ways to Speed Development of Imaging Methods

BETHESDA, Md—Representatives from government, industry, and aca-demia met for a day and half to discuss the barriers that limit more rapid development of imaging techniques needed by cancer researchers and physicians—and possible ways to overcome them.

Richard D. Klausner, MD, director of the National Cancer Institute, which organized the meeting, said it was the first in a continuing, long-term discussion on imaging issues and that the format of the meeting would serve as a model for resolving other problems in developing new tools against cancer, including drug development.

Dr. Klausner and Robert E. Wittes, MD, director of the NCI’s Division of Cancer Treatment and Diagnosis, reported on the imaging meeting to the National Cancer Advisory Board (NCAB).

Attendees at the imaging meeting included officials from the NCI, Food and Drug Administration, and Health Care Financing Administration; representatives from a variety of medical device companies; cancer researchers; and Capitol Hill staff members, Dr. Klausner told the NCAB members.

The NCI designated imaging technology as one of its “Extraordinary Opportunities for Investment” in 1996. These are “areas of discovery with exceptional promise for achieving pivotal advances in our knowledge about cancer,” Dr. Klausner said. Then the Institute moved forward to gain the cooperation and participation of the imaging industry.

In talking with business executives, NCI staff found that many lacked a clear idea of what devices cancer physicians and researchers think they need. So the Institute began thinking of holding a scientific conference to clarify the question of what researchers need.

However, further discussion made it “increasingly clear that that was only the tip of the iceberg,” Dr. Wittes said. Major issues for business executives included regulations governing FDA approval of new imaging techniques and concerns about whether third-party payers would provide adequate reimbursement to make their investments worthwhile.

“The Health Care Financing Administration is the government’s own insurance company, and what we found in these discussions was an overwhelming concern with the unpredictability of the reimbursement situation for emerging technologies,” Dr. Wittes said.

Wide-ranging discussions at the meeting covered many topics, and both Drs. Klausner and Wittes professed satisfaction with the exchanges and the pledges to continue discussions and work on solutions. Dr. Klausner called the effort “an interesting experiment that we would like to expand.”

A Continuing National Forum

Dr. Wittes noted that a great amount of effort must go into creating a continuing national forum to address and resolve issues that limit the development and approval of advanced imaging devices. As an example of what this might accomplish, he cited “working with the FDA to do things like make approval steps as defined, predictable, and rational as possible,” as well as very public so that companies can do “better calculations of financial risk.”

However, Dr. Wittes made it clear that progress will not come easily. “We are under no illusion how difficult this could be,” he said.