For Cancer Patients, Clinical Trial Process Offers Hope And Requires Patience

Nov 25, 2019

Cancer is the second-leading cause of death in the U.S., close behind heart disease. So, when there's talk of a new cancer drug discovery, patients and their relatives often want to know more about the pharmaceutical and when it might be on the market. 

Jackie Iannarelli is a quilter. She's doing a lot of quilting these days for friends, family, and charities. But over the last decade, she hasn't always felt up to it: she's had two bouts of breast cancer.

The disease is currently in remission. But cancer is still on Iannarelli's mind. The Grafton resident recently sent us a Beats Me question asking that when we report on possible cancer drugs, that we look into the clinical trial process and how long it takes pharmaceuticals to reach consumers.

"I just had a friend who had cancer 15 years ago, die a month ago from this same kind of breast cancer. And, anytime anyone talks about cancer, it's still 'The Big C.' You want to find out as much information as you can, so that you're educated about the disease," Iannarelli told WUWM.

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A close-up of the cancer quilt created by Jackie Iannarelli.
Credit Chuck Quirmbach

The answer to Iannarelli's question often starts at a national network of research centers that receive funding from the federal government's National Cancer Institute. The Medical College of Wisconsin (MCW) is part of that network. More than 250 clinical cancer trials, covering at least 13 types of cancer, are underway at Froedtert & the Medical College of Wisconsin health network, the most in the state. 

Dr. Stuart Wong is a professor of medicine at the MCW. He's an oncologist, usually working with patients who have cancers of the head, neck and skin. Wong is also a researcher who runs clinical trials involving volunteer patients. He says those trials only start after much testing in the lab and on animals. The focus is both on how much harm the drugs may cause, and how well they do.

"In the laboratory, you look for effectiveness. In the animal studies, you also look for effectiveness. But when it gets to humans, a great deal of concentration is made on safety and side effects. Also, toxicity. And then you get back to the efficacy — how useful it is in killing cancer cells," Wong explained.

Wong says some of the trials can take years. But he says the Food and Drug Administration (FDA), which has to give the go-ahead on clinical trials and gets the final say-so on market approval, has sped up some things.

Dr. Stuart Wong, outside his office at Froedtert Clinical Cancer Center.
Credit Chuck Quirmbach

"Maybe a new drug has some very early promising evidence and then it can be fast-tracked — in response to the fact that there are patients, real patients out there with serious, life-threatening diseases," Wong said.

But while there have been many advances in cancer drugs, controversies remain, including over transparency. NPR reported last month that Canada has decided to post online, many company-generated documents, summarizing the methods, goals, and results of clinical trials. But the FDA usually treats that information as confidential.

Other reports show the pharmaceutical industry, which funds some clinical trials, continues to try to win over researchers and physicians with financial incentives like paid speaking engagements. Wong says he and many of his colleagues choose objectivity.

"I personally don't do any of the talks, and don't go to any of the dinners, because I'm a researcher and want to stay as objective as possible," Wong said, adding that if he does go to a company-sponsored dinner, he pays his own way.

National media also report that to some extent, women, the elderly, and racial minorities, have often been under-represented in clinical trials. Dr. Jordan Berlin, of Vanderbilt University Medical Center, agrees the record falls short, including on minorities.

"There are a lot of reasons, historical and otherwise, that have led to this, and overcoming this is not necessarily an easy task. But I know a lot of us have been trying very hard to do so," Berlin said.

Dr. Ann Nattinger, associate provost for research at MCW, said in a written statement:

MCW’s Office of Research agrees that gender and race/ethnicity representation have historically been biased against both women and racial minorities, and strives to close the gap. MCW expects its investigators to follow the NIH policy, which is quite explicit in requiring equity by gender and race/ethnicity for clinical trial enrollments.
 

It appears that this expectation is working. As an example, an analysis of cancer clinical trials by gender for July 2017 through June 2019 showed that 55% of the subjects accrued during that time period were female.

Access of minority subjects to clinical trials is also tracked. Of subjects accrued during the same time period, 85% were white, 9% black-African American, 3% Latino, 1% Asian, 1% American Indian-Alaska Native, and the remainder unknown. Our accrual by race-ethnicity generally reflects the state percentages, with some over-representation of black-African Americans, who make up about 6% of the state population. We are working to increase our minority accrual even further by employing culturally-sensitive navigators and translation services where appropriate. 

In response to a later query about the elderly taking part in clinical trials, MCW replied, "Subjects age 60-plus accounted for 51% of cancer clinical trial enrollments in FY 18-19."

Even with refinements in clinical cancer trials, an MIT study last year showed only a small percentage of those drugs win FDA approval. In Grafton, Jackie Iannarelli says she's not surprised.

"But it still offers you some hope, because they're still working on it, and they haven't given up on it, for which I'm grateful," Iannarelli said.

Support is provided by Dr. Lawrence and Mrs. Hannah Goodman for Innovation reporting.

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