In this decade, cancer will surpass cardiovascular disease as the leading cause of death in the U.S. Recent statistics also show that one in two men and one in three women in the US will develop cancer during their lifetime.
Patients often ask me if enough money is being spent on cancer research, what are the obstacles to cure? These diagrams show the amount spent on the total US Health Care dollar is $1.3 trillion/year, of which $18 billion are spent on oncologist clinical services/year and another $33 billion spent on chemotherapy/year (View Diagram).
Since 1990, cancer research funding has tripled to $23 billion/year ($5 billion more than oncology clinical services) of which most community oncologists do not participate in any clinical research as a Principal Investigator. Our nation invests $17,700 research dollars relative to each of the 1.3 million new cancer patients diagnosed yearly. Yet only 3% (39,000) of cancer patients participate in research trials, with each patient relatively utilizing $590,000 research dollars from the $23 billion spent yearly on their behalf (View Diagram).
From the patient’s perspective, system inefficiencies along with a lack of awareness and access account for 97% of those who do not enroll in trials. 86% of cancer trials do not even meet their original enrollment goals for participation (accrual goals). Millions of research dollars are lost daily for idle research trials that do not accrue patients. Thus, we have invested enough money in cancer research, but our nation cannot capture its return on investment in our broken clinical research system.
Despite the large number of drugs in clinical trials, only 16% of oncologists are Principal Investigators, most of which are concentrated in academic centers. This low oncologist participation illustrates the compounding lack of access to early phase experimental cancer drugs on clinical trials. A Harris interactive survey of 6000 cancer patients revealed that 85% of cancer patients were not even told by their oncologist about clinical trials as an option. Furthermore, most would have participated in clinical trials if they had access or known about it. The large number of experimental drugs in the pipe-line, along with an increasing awareness of clinical trials has created a growing patient demand to the cutting edge. Due to increasing awareness, such as Lance Armstrong’s Tour of Hope, access to clinical trials has become paramount agenda of many community cancer programs. The Center for Medicare Services (CMS), the National Cancer Institute (NCI), and the FDA have made participation in cancer research trials a top national focus. Specifically, CMS has initiated steps to accelerate enrollment and increase reimbursement for clinical trials.
Early phase trials (also known as Phase I trials) are “first in human” experimental drugs in their earliest phase of clinical development (View Diagram). Over 400 investigational cancer drugs are currently in development, all of which must pass through Phase I clinical trials. Also, in 2004, the number of clinical trials sponsored by the BioPharma industry surpassed the number sponsored by the National Cancer Institute (NCI). This is a massive pipeline of hope for patients with incurable metastatic cancer, but with limited access to sites with Phase I research capabilities. Novel investigational drugs are not offered in most communities due to a lack of experience and dedicated oncology Phase I research centers.
A recent New England Journal of Medicine article reviewed the response rates of early phase experimental cancer drugs in all the published clinical trials and found an average 44.7% of cancer patients clinically benefited by phase I trials; 34% tumors stabilized, 7.5% substantial shrinkage (partial response), 3.1% tumors completely disappeared (complete response).
Understanding clinical trials is paramount to every cancer patient who desires access to cutting edge research. Due to lack of U.S. trial participation, patient misperceptions and system inefficiencies, drug discoveries in the lab are not entering clinical trials fast enough. |
