A deputy director from the National Cancer Institute (NCI) has proposed a radical overhaul of the way NCI allocates oncology clinical trial funding. His proposal would eliminate disparities in oncology clinical trial participation and health outcomes resulting from differences related to race, ethnicity and income. Dr. Jon Kerner, who works in the Division of Cancer Control and Population Sciences, shared his ideas at a recent roundtable held at Baylor College of Medicine.
Typically, only 3% to 5% of cancer patients participate in oncology clinical trials, a low percentage that slows down the drug development process. Most discussions about eliminating disparities in clinical trials focus on increasing the number of cancer patients among racial and ethnic minorities, but not on the overall percentage of cancer patients participating. So, more racial and ethnic minorities could participate, but the rate of cancer patient participation would still remain abysmally low.
Kerner has asserted that what’s actually needed to increase minority participation, overall participation and advance science is inclusion of 100% of all the patients who have the cancers that meet his three criteria: scientific opportunity, distinct disparity in terms of who gets them and/or who dies from them and high fatality rates...
In the 1970s, pediatricians waged war on pediatric cancer by attempting to recruit every child with cancer in the U.S. into a clinical trial, regardless of race, ethnicity or income. Tremendous progress was made between the mid 1970s and mid 1980s in pediatric cancer, and it is one of this country’s great success stories in cancer treatment.
Given that the NIH budget has been decreasing, NCI has had to cut new grant awards by 29% this year alone. Kerner suggests that if NCI were to concentrate its limited resources on enrolling 100% of patients with cancers that meet his three criteria, NCI would be able to spend more money per patient on a clinical trial.
Those in rural areas or without access to good public transportation could get transportation costs to Centers of Excellence covered. The uninsured and the insured with fatal cancers would be in the same boat, thus removing the ethical dilemma of letting patients “choose” between healthcare through participation in clinical research and no healthcare at all.
NIH-funded phase III oncology clinical trials all have two arms, one offering standard care and the other perhaps something better. No matter what the patients’ background, it is the best care available and at the same time presents an opportunity to advance science.
Right now, government funds clinical trials in many cancers, duplicating the efforts, in many cases, of industry. Government spreads its budget very thin and in so doing spends too little on clinical trials in cancers that industry is not conducting because they won’t make enough return on their investment.
Near total participation in oncology clinical trials has already proven successful in pediatric oncology 20 years ago. If the government chose not to run clinical trials in breast and colon cancer, for example, it would undoubtedly be unpopular with advocacy groups. But, it may be time to realize that industry is better suited to take on the high-incidence cancers and that the role of government is to take on cancers where it can make the biggest difference.