Overhauling Clinical Trials

The nation’s publicly funded clinical trials system may not have been broken, but it did just get some long-overdue repairs. Cancer experts across the country are now watching to see whether the fixes will make research trials more efficient, faster and, ultimately, easier for patients to enter. Without clinical trials, new drugs could not come to market—and many patients would not have access to the latest therapies.

While drug companies fund many research trials, the government also supports a network of more than 3,000 institutions and 14,000 investigators to test new therapies. Founded more than 50 years ago, the National Cancer Institute’s Clinical Trials Cooperative Group plays a key role in developing new and improved cancer treatments. Few disagree that the clinical trials process was in need of an overhaul. For one thing, the system took too long: Once the initial concept for an investigation got approval, it was not uncommon for a study to take more than two years to get off the ground. Sometimes, studies would be mired in the process so long they would be scientif-

ically outdated before they even began. Recognizing the problem, the NCI recently asked the prestigious Institute of Medicine (IOM) for an evaluation of the agency’s clinical trials network. In April 2010, the IOM panel rendered its opinion: the current system was inefficient, underfunded and overly complex. “The need to streamline the clinical trials process is pretty clear,” says Minetta Liu, MD, of Georgetown University’s Lombardi Cancer Center in Washington, D.C.

The NCI responded to the report in December, announcing major changes to the way clinical trials are approved and executed. “Not only will new studies get to patients faster, but we’ll get answers faster,” says James Doroshow, MD, director of the NCI’s division of cancer treatment and diagnosis. Many of these changes had been under way even before the December announcement. Among them, the system for adult trials is being consolidated from nine separate cooperative groups into four; the time to develop a phase 3 trial will be reduced to less than a year; and scientists writing study protocols will no longer have to deal with “a system of chutes and ladders,” where even minor tweaks in a study design could send the entire process back to square one, Doroshow says.

The changes come at a time when many oncologists lament the lack of participation in adult cancer trials. Only about 3 percent of adults participate in clinical trials. In its April report, the IOM warned, “If the clinical trials system does not improve its efficiency and effectiveness, the introduction of new treatments for cancer will be delayed and patient lives will be lost unnecessarily.” Among the new changes, the NCI plans to make the logistics of clinical trial participation friendlier to community physicians by providing a common computer program, accessible in any doctor’s office, for all trials.

These and other changes are necessary for patients to benefit from new discoveries in cancer genetics and other processes that drive malignancies, says Laurence Baker, DO, of the University of Michigan Health System, who heads Southwest Oncology Group, one of the largest NCI trial groups. Laboratory discoveries cannot benefit patients unless they are translated into new drugs and useful tests. Drug companies conduct a lot of cancer research, Baker points out, but for corporate interests and not always in line with the greatest patient needs. “Having a publicly funded clinical trials network is vital for progress in cancer treatment,” he says.