A $3 billion cancer research program created by Texas voters in 2007 has set its primary goal as creating a new cancer trials network that will address the shortcomings of existing systems for clinical cancer research.
National Cancer Institute director Harold Varmus, MD PhD, admits to being both envious and inspired by the Cancer Prevention and Research Institute of Texas (CPRIT), which was created in 2007 by a state constitutional amendment and a $3 billion ten-year appropriation resoundingly approved by voters. CPRIT, which calls itself the second-largest cancer research granting agency in the United States, has a mandate to expedite the clinical application of cancer research. Its first major step toward that goal is creation of a statewide clinical trials network (CTNet), launched with a $25 million seed grant three months ago.
"As somebody sitting on a substantial budget that is shrinking as we watch, it is envy-making to see people making investments in new opportunities," Varmus remarked at a press briefing yesterday. The briefing preceded a roundtable discussion about how best to achieve CTNet's goal to address many of the shortcomings with the current cancer trials process, which were aired in an Institute of Medicine report last April.
An experiment in clinical trials
Some "central tenets" that are already set will answer many of the IOM's criticisms, according to CPRIT Executive Director Bill Gimson. These include:
• A centralized IRB that will create standard research protocols, with input by local IRBs only for local issues. (In many current trials, input into protocols from local IRBs has often slowed the process to a pace that outdates them by the time results are in.)
• Centralizing procedures for tissue banking and molecular genetics at branches of Baylor College of Medicine. (Nonstandard processes often make different trials difficult to compare.)
• A stated intention from the outset to create collaborations between three cultures: academic medicine, community oncologists, and life scientists.
Varmus called the Texas initiative a "very important experiment" in this regard. "There's a lot we are wrestling with at the moment about how to make changes in a system that already exists [the cooperative oncology groups]," he said, adding that he assumes the two networks will cooperate.
"I think a strong program in Texas will only strengthen us," said Robert L. Comis, MD, chairman of the Coalition of Cancer Cooperative Groups and head of the Eastern Cooperative Oncology Group,responding to a request for comment on the subject. He added that he hoped that CTNet would work with the cooperative group system to help it speed its own clinical trials process. Major institutions in Texas have been integral to that network in the past, he said.
"The most important thing to 'streamline' is how the science is done," Comis added. "In the cooperative group system we have four government agencies to deal with-NCI, FDA, OHRP and (indirectly) CMS. Hopefully, Texas can avoid all of these beauracracies which impact on how we do things and what can be done." Any effort that increases public participation in clinical trials is to be welcomed, he observed.
Only Texans need apply
Only applicants based in Texas are eligible for research grants from CPRIT, which anticipates setting aside some funds for CTNet trials of its own choosing, said CEO Gimson. Once CTNet is established, he added, CPRIT anticipates that other agencies, institutions, and donors will contribute to funding its trials.
CPRIT claims a blue-ribbon Scientific Review Council, chaired by Nobelist and MIT cancer biologist Phillip Sharp, PhD. Vice Chairman of the Oversight Committee is Houston oncologist Joseph S. Bailes, MD, who is a member of the ASCO Foundation Board.
As of last January, CPRIT had awarded more than $250 million in grants. Many of these projects were described in a conference in Austin last week. Among the more interesting are two under way at the University of Texas Southwestern Medical Center at Dallas. One aims to find hormonal markers for lung cancer. The other is seeking the molecular mechanisms that underlie invasiveness of glioma cells within the brain.