NIH Funds AIDS Center At Harvard

Harvard's School of Public Health is establishing a multi-million dollar clearinghouse for AIDS research under the wing of the National Institute of Health (NIH), University and NIH officials said this week.

Called the Statistical and Data Analysis Center for the AIDS Clinical Trials Group, the institute will compile information from and design proposals for research at 45 institutions and more than 100 clinics across the country.

"The center provides an essential link to getting data analyzed and reported as quickly as possible," said Dr. Marcia A. Testa, an SPH lecturer and director of one of the center's three divisions. She said that center will be the first national group to coordinate programs for AIDS research.

NIH will fund the center with a five-year grant of about $38.6 million, said Leslie Fink, a spokesperson for the National Institute of Allergies and Infections Diseases, the NIH division overseeing the project. Fink said NIH chose Harvard from a national competition.

"The real motivation for the center was the need for a full-fledged center with people with a high level of quantitative expertise," said Stephen W. Lagakos, the professor of biostatistics at the School of Public Health who will direct the center. He said that when the government first began funding AIDS research, it envisioned individual groups that would conduct small studies on their own.

But, he added, the discovery of AZT--the only drug currently approved for the treatment of AIDS--several years ago precipitated the need for larger studies and made it clear that cooperation was necessary.

Testa said she hoped the center would reducethe time needed to test new drugs.

"The whole emphasis is on accuracy and speed,"Testa said. "We don't want to approve a drugthat's not safe, but we don't want people waitingaround."

Testa said the aim of the center was to makethe studies uniform and increase the ability toevaluate drugs more rapidly and get them to themarket more quickly.

"It's long overdue," said Steven D. Busby, amember of the AIDS Coalition To Unleash Power,known by the acronym ACT UP.

Under the previous system, data collected wasvirtually irretrievable."

"Some [data] was analyzed, put into storage andnever used again, and some of it was simply lost,"Busby added.

Busby said he hoped a nationally coordinatedsystem would prevent this waste of information.

AIDS research is divided into three phases.During Phase I testing, a few individuals aretested to determine the safety of a new drug.Phase II testing involves 30 to 60 patients, whilePhase III testing consists of a full-scaleevaluation of a drug's effectiveness, especiallyin relation to current treatments.

Testa said a single national center was needed"because no one can get enough people in one placefor a Phase III trial."

At the moment, many people are participatingunder the national system. "Things are bursting atthe seams at this point," he said.

Lagakos also said the center should work withcommunity-based clinical testing. "Communityphysicians are not at the front line of research,yet they are at the front line of treatment," hesaid. We would like to coordinate studies to makesure we are moving forward in the same direction.