Oncology survey finds optimism, cost concerns
Personalized medicine is hot trend
Oncologists and medical directors say that 38% of their patients could benefit from participation in clinical trials, but only about 5% actually enroll in an oncology study per month, according to a recent survey.
The low trial participation is due to perceived cost barriers, the survey found.
"Oncologists understand science and the potential benefits these [investigational] drugs provide," says Scott Bazemore, director of clinical research development at U.S. Oncology Research of U.S. Oncology in The Woodlands, TX.
The problem is a matter of navigating red tape and bureaucracy, Bazemore says.
U.S. Oncology sponsored the survey, which was conducted by KJT Group. The survey included 299 oncologists, hematologists, and clinical trial professionals. Interviews were conducted in the summer of 2009.
U.S. Oncology is affiliated with 1,310 physicians in 493 locations, including 98 radiation oncology facilities in 39 states.
The study also found acceptance and optimism among oncologists for clinical trials that involve personalized medicine.
Overall, 57.5% of respondents said they are optimistic about the future of clinical trials in the United States, while 17.1% expressed pessimism, and 21.1% said they were ambivalent.
More than half of the oncologists and medical directors surveyed believe it would be easier to recruit patients to clinical trials for targeted therapies than to large-scale, randomized trials of more traditional cytotoxic therapies.
The rise of personalized medicine
Personalized medicine is a growing trend in oncology, Bazemore notes.
"The last five years have been exponential in the era of personalized medicine," he says. "It's been out there for a while, but the biggest jump into this was the perception a couple of years ago where they looked at targeting a specific marker in breast cancer patients and targeting that specifically."
The idea is to stop throwing a lot of chemicals at patients but instead targeting specific proteins, he adds.
"We're quickly heading toward an era where no one really cares about the location of the tumor, whether in the breast, prostate, or lung, but we'll look at that specific tumor and target treatment for it," Bazemore says.
This approach preserves more of the healthy tissue.
Some call it precision medicine because the treatment looks at the precise way to exploit the genetic signature of a tumor by battling it with a drug that attacks the biomarkers on that cancer cell, sparing the normal tissue, Bazemore explains.
"The better the technology gets in identifying markers and new pathways, the faster we have new targets to exploit," he adds. "As the science gets better it dictates what happens downstream in the clinic."
This means there need to be more personalized medicine clinical trials conducted by physician scientists, he says.
"There is a high level of acceptance of precision or personalized medicine in community-based medical systems," Bazemore says. "The biggest barrier is insurance coverage."
Sponsors will pay for the investigational drug, and insurers pay for standard care, but the gray area involves the expensive process of identifying the target area for precision medicine, he explains.
"The new genetic signature and protein expression level is a very new test, and it's not paid for by insurance groups," Bazemore says. "Also, many insurers will not allow patients to be repaid for standard of care treatment if they're also receiving investigational treatment."
More than 90% of oncologists and medical directors surveyed reported they already treat patients with a personalized medicine approach. On average, 40% of their patients are treated this way, and breast cancer was the most common tumor type treated with a personalized medicine approach, the survey found.
About 58% of those surveyed said the most likely factor to increase the number of patients participating in clinical trials would be mandated health plan coverage of treatments.
Kind of a drag
Also, 86% of oncologists said they think the clinical trial approval process takes more than a year due to regulatory red tape. Other factors they reported slowed the CR process are as follows:
- Inefficiency of initiating organization - 51%;
- Lack of funding - 44%;
- Excessive analysis - 29%;
- Targeting wrong patient population - 20%;
- Asking wrong clinical question - 15%.
"Of the 1,300 physicians in the network, approximately 750 pay very strict and close attention to clinical research," Bazemore says. "Close to 60% have a very detailed approach to clinical research, and about 150 or 20% of them are heavy adopters of personalized or precision medicine in a trial."
The survey's data show that oncologists would like to get involved in personalized medicine research, but they find it quite difficult to navigate, Bazemore says.
"It distracts them and takes them away from other trials that might be easier to navigate and which might be as relevant to the patient," he adds.