Conflict of Interest in Cancer Clinical Trials
Kevin B. Knopf, MD MPH, Medical Director, Cancer Commons
San Francisco, California
Q: Clinical trials are the lifeblood of continuing drug development in the US. Yet they are often undersubscribed. What do you see as key conflicts of interest in recruiting for patients in the academic medical center, the hospital, and the private oncologists’ practice?
A: Recently readers of this blog engaged in a spirited debate about conflict of interest in cancer clinical trials. The issue was divided as to whether or not the treating oncologist was the best person to offer a patient a clinical trial. I might suggest that the question can not be reduced to an “either or” answer – but is best understood as an asset allocation problem – the result of increasing financial pressures on cancer care due to trends over the past several decades.
The patient’s interest is in finding the best possible treatment for their cancer – on or off a clinical trial. The provider wants the patient to achieve the best possible outcome for their cancer and has an altruistic motivation to find better treatments for other patients. At the same time any provider stands to gain financially or secondarily (publication, promotion) from their involvement with a clinical trial. PHARMA has vested interests in finding new drugs that will provide return on investment and wisely invests heavily in clinical trials.
The American oncology enterprise is adopting to thinner profit margins. There is less profit from chemotherapy and radiotherapy reimbursement, and funding by the NCI for research is at a 20 year low. Thus the necessity of running clinical trials as a “revenue surplus” has risen – particularly in academic medical centers. At the same time clinical trials are the main engine that drives progress in cancer care.
I believe a partial solution is to reallocate assets in cancer care to ease some of the financial stress felt by academic medical centers and community based practices. When we stop paying so much for things that don’t help our patients we have more financial assets to investigate trials of drugs that can actually help them. For example, overly aggressive oncologic care at the end of a patients’ life with prolonged (and expensive) stays in the Intensive Care Unit rather than a timely referral to hospice are unlikely to help as many patients as discovering a novel therapy might. Reduplication of imaging studies at multiple institutions if they don’t add to patient outcome is a second. The ASCO “choosing wisely” campaign, if followed fully, would be cost-effective for the cancer care system. This will reduce some of the financial pressure that might drive patients into clinical trials for reasons other than purely altruistic ones.
Health economics – the fuel for the engine that drives cancer care in the United States – is a zero sum game. With the declining funding rate from the NIH funding for clinical trials is dependent on honest and moral relationships with PHARMA. The cooperative group trials from the NIH are financial “loss leaders”. At a time when funding for cancer research from the NCI is diminishing and we have a record number of new cancer drugs approved we are now dependent on industry sponsored trials to keep the research endeavor going. Value based cancer care seems to be the catchphrase as we struggle with rising costs of treatment. What may help us ultimately are a series of real world clinical trials with economic endpoints to find cost-effective opportunities for cancer treatment. We should redouble our efforts to curb endeavors that seem purely destined to bring “economic friction” in cancer care. A wiser approach to economic asset allocation in cancer care could free up the financial pressures at the heart of this conflict of interest and start to minimize – but never completely erase – this conflict.
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