During the 2008 presidential campaign, Barack Obama promised to boost patients' access to clinical trials for new drugs.
Clinical trials are studies in which patients are assigned to receive one or more interventions, such as a drug or other therapy, or no intervention at all, so that researchers can evaluate whether the drug or therapy is safe and effective.
The key part of the promise is Obama's pledge to require "coverage of patient clinical trial costs in the new public and private plans offered through the National Health Insurance Exchange.”
This part of the promise was largely kept -- although it merits an asterisk.
The big health care law Obama signed -- the Patient Protection and Affordable Care Act -- says that insurers "may not deny” individuals' participation in clinical trials and may not limit or impose additional conditions on the coverage of "routine patient costs” stemming from the trial. This is set to take effect on Jan. 1, 2014. (Additional details are available here and here.)
Getting the clinical trials provision into the law was something "patient advocates fought long and hard for, so we considered it a victory,” said Shelley Fuld Nasso, a health policy consultant for the National Coalition for Cancer Survivorship.
Still, Nasso acknowledges that the battle is not entirely over. On Dec. 26, 2012, her group submitted comments to Health and Human Services Secretary Kathleen Sebelius urging the department to make sure the clinical trials provision is specifically included when it crafts more detailed guidelines for implementing the health care law.
Nasso describes the group"s comments to Sebelius as "due diligence to ensure that the provision is implemented as stated in the law,” adding that "we believe it will be.”
Sara Rosenbaum, the chair of the Department of Health Policy at George Washington University, said the group's decision to keep the pressure on is probably a wise one. "The law is relatively specific in certain respects, such as the definition of what is an approved clinical trial, but unclear in other ways, most specifically the relationship of the clinical trial standard and the” subsequent HHS standard, known as "essential health benefits.”
Meanwhile, the Obama administration has made progress on the other parts of the promise -- to identify regulatory barriers and to increase National Cancer Institute reimbursement for patients taking part in clinical research.
In 2009, the National Cancer Institute asked the Institute of Medicine, an independent scientific body, to review the cancer institute"s clinical trial program. The Institute of Medicine produced a report on April 15, 2010, that found problems with inefficiencies and underfunding.
Partly to address these concerns, the Board of Scientific Advisors of the National Cancer Institute in 2011 approved a proposal to fund the Integrated NCI Clinical Trials Network, which, among other things, increases reimbursement for enrolling patients in trials by $2,000 for high-performing centers. On July 23, 2012, HHS posted an offering of funds in which the National Clinical Trials Network will commit about $90 million over five years.
Finally, the Food and Drug Administration has issued a draft guidance that outlines strategies for completing trials for rare cancers and other rare diseases, a document that "demonstrates the willingness of FDA to clearly articulate standards for clinical trials," Nasso said.
In all, the administration has made significant progress on each of the elements of this promise. There is some concern about whether the final regulations will stick to what the health care law promised, but if they do not, we will take another look at this promise. For now, we rate it a Promise Kept.