Clinical trials in the news

Tony Spirito on teens' suicide attempts; Kay Dickersin shapes debate on trials registries; Timothy Rivinus on antidepressants and kids

by Wendy Y. Lawton

Clinical trials registries allow scientists, doctors and the public to see what drugs, devices and public health strategies are being tested for safety and effectiveness. If a trial is completed, people can see the results - good, bad or indifferent - and decide whether that pill or pacemaker or diet program is right for them.

Kay Dickersin (left) has championed trials registries for 20 years, arguing that they improve consumer health and medical care and eliminate costly, duplicated research. Now that negative, and previously undisclosed, results of pediatric antidepressant trials have come to light, registries are the rage and Dickersin is a sought-after expert.

In recent weeks, the community health professor and head of Brown's Center for Clinical Trials and Evidence-based Healthcare has been quoted on the topic in The New York Times, The Washington Post and Science. Last month, she was a guest on "NewsHour with Jim Lehrer," the national PBS show, to discuss trials registries.

But Dickersin isn't just weighing in on the debate. She is also shaping it.

Dickersin is a key player in a push by the World Health Organization to organize a global trials registry. The concept: Create a single entry portal to provide electronic access to all trials registries. WHO would assure that each trial is assigned a unique identifier and would oversee development of the connection among the registries and the portal. The global health agency would also encourage participation and standardization so the registry would be complete and accessible.

Dickersin wrote the white paper for the WHO effort and will meet with major funders and stakeholders in New York City this month. The initiative will be unveiled to national health ministers in Mexico City in November. Dickersin will be at the meeting.

After years of advocacy, Dickersin is pleased that trials registries are getting attention.

"I think people now understand the problem and they see the need," she said. "What we haven't gotten past is how to make registries work."

A major U.S. trials registry was created under a federal law in 1997. But critics, including Dickersin, say the registry is inadequate and unenforceable. New bills in Congress would create a new registry. Dickersin worries that these efforts may fall short as well. One example: Some focus only on drug industry trials.

"What if someone does a trial testing a way to reduce obesity through diet or reduce migraine headaches through exercise?" she asked. "People will want to know that information. But they wouldnÕt get it under the system proposed by these bills."

Dickersin found her passion for trials registries early in her career. In the middle of her doctoral studies at Johns Hopkins, she worked for Tom Chalmers, a pioneer of meta-analysis, a review technique that combines data from several trials. Digging for results for Chalmers' reviews, Dickersin learned that some trials weren't published. They were the one showing that a treatment wasn't effective, or even harmful.

This tendency for reporting positive results, called publication bias, struck Dickersin as a serious health issue. "It wasn't esoteric," she said. "You can't practice evidence-based health care without all the evidence."