Meanwhile, a broad new NCI initiative to consolidate the institute’s community research programs into one, whose agenda also includes parallel nonclinical research on cancer care delivery, had several of the workshop participants concerned about the potential for added financial and logistical strain on community affiliates.
Dr. Robin Zon
"We don’t want to stress private practices," said Dr. Robin Zon of the Northern Indiana Cancer Research Consortium and Memorial Hospital in South Bend, Ind., of NCI’s added research focus on care delivery. "There has to be a streamlining, otherwise they will opt out."
Dr. Zon also cautioned that researchers on the community level face the "real issue of payers not covering clinical trial participation," at least until January 2014, when federal law will require that insurers not deny patients participation in clinical trials or limit coverage of routine patient costs stemming from a trial. "Let’s try to lobby to make sure that this becomes imperative," Dr. Zon said.
The trials network’s total funding for fiscal year 2014 was $152 million, Dr. Comis said, adding that he was hoping to increase that to $178 million. One of the stated goals of the overhaul was to increase reimbursement per patient enrolled from $2,000 to $6,000, but increases have not yet been universally adopted. The 2010 IOM report also recommended other incentives to increase accrual, such as reimbursing physicians for offering patients the option of enrolling in a trial, even if the patient ultimately chooses not to. This recommendation has not yet been adopted.
The United Kingdom’s experience overhauling its own trials network offered valuable perspective on what was happening in the United States, despite major structural differences between the countries’ health care systems. In 2001, the U.K.’s cancer trials network was reorganized out of a similar "sense of crisis and national purpose," said presenter Dr. Richard Kaplan of University College London Hospital and the U.K. National Cancer Research Network. Prior to 2001, Dr. Kaplan told the conference, research was not considered part of the National Health Service’s cancer care agenda. Now, it is understood that NHS exists partly to do clinical research, "a view that has become ever more firmly embedded in constitution of NHS."
Some of the key changes that allowed the NHS to manage clinical trials included the hiring of dedicated research staff, particularly research nurses, who cannot perform nonresearch-related duties within the hospitals. The NHS also covers costs for all patients enrolled in a trial. Currently, Dr. Kaplan said, 23% of cancer patients in the United Kingdom are enrolled in trials, and 7.5% in randomized trials. All in all 19,000 patients are currently taking part in trials, making the U.K. network comparable in size to the U.S. network, despite a vastly smaller national population. It is also comparable in terms of annual budget, Dr. Kaplan said, with the NCI trials network, with funding coming from government, charity, and industry sources.
One important difference between the United States and the United Kingdom is that novel agents are available only within license in the U.K., providing a powerful motive to both patients and providers to enroll. "The clinical oncology community within the NHS – there’s very little private oncology – were frustrated with the fact that they had limited ability to provide new agents or move forward and so, when it was given to them, they embraced it," Dr. Kaplan said.
Clinicians in the NHS system get an annual review, Dr. Kaplan said, "and nowadays they get asked how much they are participating in clinical trials. They lose face if they haven’t – people pay attention to the fact that if you’re an oncologist and don’t participate, it doesn’t look good."
Still, the U.K. trials system is not leading the way in phase II or biomarker-driven trials at the community level, Dr. Kaplan acknowledged. It has thus far emphasized phase III trials, though 4 years ago, it began to prioritize phase IIs, which have increased as a share of trials underway. Dr. Kaplan said many local NHS networks have tended to "avoid more complex studies, favoring easier studies."
Dr. Bertagnolli said in an interview following the conference that she was confident that cutting-edge science could be conducted well beyond the bounds of dedicated cancer centers in the United States.
"We need to make it possible for these types of studies to be done in our community oncology sites. I don’t think we can effectively accomplish even those goals in this era where we’re looking at smaller and smaller patient populations without engaging the community oncology sites."