For community cancer centers that rely on patient reimbursement to stay afloat, a smart data-driven approach to clinical trials provides a foundation for future growth.
By TANDY TIPPS and BRENDA NOGGY
Covid-19’s tragic, devastating impact on cancer treatment is now well documented. Cancer screenings dropped by almost 90 percent at the peak of the pandemic. Billing for some leading cancer medications dropped 30 percent last summer. Studies found a 60 percent decrease in new clinical trials for cancer drugs and biological therapies.
Cancer centers, like every part of the US health system, have a lot of ground to make up. Those community cancer centers without grants and other institutional advancement funds, experience financial and human resources as major constraints to charting a path to growth. For them, successful programs which generate revenues for expansion or break even help them maintain fiscal health. Often, unfortunately, too often their research programs lose money.
Clinical trials have not been a viable revenue source because of the difficulty in accurately predicting patient enrollment and the challenges of managing trial portfolios, a task that requires streamlined feasibility processes that include querying baseline populations for new trials and potentially eligible patients.
The hard work of patient screening and trial matching requires clinical coordinators, physician investigators and research support staff to spend between three to eight manually scouring databases of electronic medical records and unstructured files to find patients eligible for trials based on increasingly complex inclusion and exclusion criteria. This costly process does not take into consideration the pre-screening efforts in patient matching that may not be reimbursable.
Resources are also needed to implement feasibility processes to accurately predict how many patients might enroll in a trial if they are eligible. Most community-based sites do not have an accurate ability to query their current patient populations by disease cohort or mutation in real time. They often rely on physicians’ memories to estimate patient numbers for trial feasibility questionnaires, which must returned to sponsors quickly, usually before cancer centers have definitive recruitment numbers.
As a result, before COVID, an average of only 5 percent of patients had a chance of participating in trials, 50 percent of clinical trials failed to meet enrollment goals and less than 14 percent were completed on time. Cancer centers still incur the administrative and clinical resources required to maintain the protocols in the first place, however.
Yesterday, 60 Minutes reported on Dr. Anil Potti, researcher at Duke University. Dr. Potti supposedly offered cancer patients improved cancer treatments. These recommendations, however, were based on falsified data.
“Five years ago, Duke University announced it had found the holy grail of cancer research. They’d discovered how to match a patient’s tumor to the best chemotherapy drug. It was a breakthrough because every person’s DNA is unique, so every tumor is different. A drug that kills a tumor in one person, for example, might not work in another. The research was published in the most prestigious medical journals. And more than a hundred desperately ill people invested their last hopes in Duke’s innovation.
In 2010, we learned that the new method was a failure. But what isn’t widely known, until tonight, is that the discovery wasn’t just a failure, it may end up being one of the biggest medical research frauds ever – one that deceived dying patients, the best medical journals and a great university.”
When the National Cancer Institute found they could not replicate Potti’s results, Duke suspended the enrollment of patients in the Potti study and asked outside review committee to analyze Dr. Potti’s discovery. After three months, however, the review committee concluded that Dr. Potti was right.
Why did no one find out earlier. Were researchers blinded by money?
Now here is a novel idea to save lives and stop the cancer plague; stop trying! Sounds as crazy to me, as it does to you, but this idea actually may have merit. Some smart people are saying that we have spent too much money for little gain, thus it is time to give up and by retreating win more battles in the war on cancer, than by charging ahead.
The Cancer Prevention and Research Institute of Texas (CPRIT) is the second largest cancer research agency in the United States, after the National Cancer Institute, controlling a pot of $3 billion dollars, most of which funds basic science and clinical research. At recent hearings, university scientists and leaders in biotech proposed that CPRIT cut back on the money it is pouring into laboratories. As Professor John Hagan of the University of Texas proclaimed, “If people didn’t get cancer in the first place, CPRIT would accomplish much of its mission.”
This radical idea was echoed in a scary article in the September issue of Lancet Oncology, entitled “First do no harm: counting the cost of chasing drug efficacy.” This editorial reviewed data, which shows that between 2000 and 2010 many new cancer drugs produced marginal extensions in survival and simultaneously increased risk of treatment associated death and side effects. The Lancet authors emphasized the vital need as we develop new therapies to carefully measure both benefit and harm before FDA approval and for careful post-marketing follow up after drugs are released to the general population.
Now in reality no one is saying that we should shut down cancer research labs and simply hope for the best. Eventually we will completely cure this disease and basic science, as well as the development of new therapies, is key to that future. Perhaps what we should hear from these words is an idea about a different balance in health and healthcare.
Like many of you, I have been reading the various news stories about Lance Armstrong, especially one this past weekend in a major newspaper, which went into great detail about the allegations surrounding Lance Armstrong’s cycling career.
But what I didn’t see in all of that coverage was much mention of the other side of the man, the side that I witnessed up close and personal one Friday in Texas a couple of years ago, the side that has led me to share my thoughts with you today.
I saw something that day that I had never-let me repeat, never-seen before. It was a moment that has forever influenced my opinion of Mr. Armstrong, even as these various charges have swirled about him these past couple of years. And the impression it created was indelible.
I am not here to hash/rehash the incriminations. I am here to stand up and say that no matter what the truth is regarding the allegations, this is a man who has forever changed the cancer landscape for millions of people in this country and around the world.
What could be more pressing than ending suffering and death from cancer — a disease that kills 155 people every day in California?
A yes vote on Proposition 29 on June 5 to increase the tobacco tax by $1 will save lives from cancer and other lethal diseases caused by tobacco, protect kids from the tobacco industry’s predatory marketing, ease the enormous economic burden of tobacco use on the state and fund groundbreaking medical research on the leading killer diseases.
Yes on 29 is an opportunity to tell Big Tobacco that enough is enough. That we’re tired of the industry’s relentless assault on our children, our health and our economy. Proposition 29 was written by the state’s leading public health groups – the American Cancer Society, American Heart Association and American Lung Association – to empower Californians to fight back against Big Tobacco’s ongoing campaign of addiction and death. Proposition 29 will also help reverse tobacco’s debilitating drag on California’s economy, saving the state billions of dollars in health costs.
The tobacco industry spends every minute of every day surreptitiously recruiting new customers: our kids. During the past decade, Big Tobacco invested 10 times more on marketing its deadly products in California than the state spent on educating the public about its harmful effects. The tobacco industry spends more than $650 million each year targeting our state with deceptive marketing designed to recruit their next generation of customers – and has already spent nearly $40 million to distort the truth on Proposition 29.
The industry’s efforts are devastatingly proficient: California’s kids buy or smoke more than 78 million packs of cigarettes each year. Nearly 90 percent of the smokers in California started smoking before their 18th birthday.