You’ve just read some exciting news. It tells you that doctors have developed a new cancer treatment for your specific disease—and it could save your life. But how soon can you start benefitting from it? Probably not tomorrow. Often, it takes months or even years for a new treatment to make its way from the news headlines to the patients it’s intended to treat. We turned to our experts to help us understand why the uptake of new cancer treatments can take time.
Right now, tens of thousands of oncologists are in Chicago for the American Society of Clinical Oncology (ASCO) Annual Meeting, the largest cancer research conference in the world. It’s the place where all the new oncology research findings are unveiled.Read More
And in today’s instantaneous news environment, huge news has a habit of going viral the second it’s announced—meaning that in the days and weeks following ASCO, you’ll likely come across countless cancer headlines touting new treatments. You’ll be sent news articles and tagged in social media posts with words like “cure.” Friends and loved ones will read the headlines and get excited for you. You’ll read the headlines and get excited for you.
And all with good reason—promising research is exciting stuff.
But as exciting (and rightfully hope-inspiring) as the news may be, only in very rare cases will you be able to read a headline about a new cancer treatment and immediately access that treatment yourself.
One of the reasons it could take months or years for a new study to start impacting patients directly is that most drugs that are proven effective and announced at ASCO still have to secure approval from the U.S. Food and Drug Administration (FDA). Other results presented might be based on early-phase clinical trials, meaning the treatments still need to go through years of testing before they’re ready for prime time (your doctor’s office).
And even after all of that additional leg work, doctors usually need time to confer with one another and make decisions about whether the new finding is strong enough to actually change the way they treat patients.
“Nationally, most people wait until experts agree that evidence is strong enough to change guidelines,” Dr. Heather Yeo, assistant professor of Surgery and Healthcare Policy and Research at Weill Cornell Medical College, and assistant attending surgeon at NewYork-Presbyterian/Weill Cornell Medical Center, tells SurvivorNet. “And actual practice can lag a little because one small study shouldn’t necessarily change an entire practice.”
It’s important to manage expectations about the amount of time it takes for cancer discoveries to impact treatment.
(But before you read on, it’s important to determine whether a cancer news headline is worth paying attention to at all. Our experts recommend asking yourself the key questions listed here.)
Clinical Trials Take Time
The most important aspect of a new study to pay attention to is the clinical trial behind it.
Clinical trials, which test new drugs in human volunteers, are as crucial to advancing the medical field as they are to saving patients’ lives. Every treatment on the market today—from ibuprofen to antibiotics, cholesterol medications, and pacemakers—had to go through a minimum of three phases of clinical trials before securing FDA approval.
In phase I, “first-in-human” trials, drugs or treatment methods are tested for safety and side effects in a small number of patients. Usually, this takes several months to about a year.
If treatments are determined safe after phase I, they go onto phase II clinical trials, where they’re tested for efficacy through randomization, meaning one group receives the treatment and the other receives a placebo. This usually takes about two years.
Finally, drugs go onto phase III clinical trials, where they’re tested for efficacy on a larger scale, for a longer period of time (usually several years). Only once a drug has successfully completed all three phases can its developers apply for approval from the FDA—a process that can take another two or more years. (Although sometimes, late-phase clinical trial results announced during conferences like ASCO are so promising that the FDA will decide to grant them accelerated approval, speeding up the time-to-market a bit).
From Lab to Patient, New Drugs Need Ten Years Total (At Minimum)
All in all, from inception in the lab to FDA approval, drug development can take up to ten years—which, especially for someone dealing with a difficult cancer diagnosis, can seem like a lifetime. And this process can take even longer if researchers struggle to recruit enough patients that fit very specific criteria.
“Because of the way the study needs to be done, not only for safety reasons, but also for scientific reasons where we’re trying to actually answer a question, we have to set up criteria for who can participate in the trial,” Dr. Alana Welm, Associate Professor in the Department of Oncological Sciences at the University of Utah, and an investigator and co-leader of the Cell Response and Regulation Program at the Huntsman Cancer Institute, recently told SurvivorNet. “Even though it makes it difficult to find the patients who are eligible.”
Doctors Need to Be Convinced
After that ten-year journey ends and a new drug or treatment gets approved by the FDA, it’s still unlikely to appear on the shelves of your pharmacy overnight. And if it does, there’s a good chance your doctor won’t start prescribing it right away, either.
Some oncologists—especially those who have been in the field for decades and have firmly established protocols for treating patients—may be slow to adopt completely new paradigms.
“I think uptake depends a little on the study itself, how it is disseminated, and how strong it is,” Dr. Yeo said.
While these lengthy steps and processes may seem frustrating—especially in the moment, when you read about an effective new treatment for your specific cancer, only to find that you can’t access it—it’s important to recognize that the reason the process takes so long is because it’s designed to eliminate any doubt in terms of efficacy, and minimize safety risk.
Understandably, doctors don’t want to give their patients anything that hasn’t been rigorously tested over and over.
“From the societal standpoint, we really cannot understand whether these therapies work without subjecting them to rigorously controlled trials,” Dr. Ben Neel, Director of the Laura and Isaac Perlmutter Cancer Center at NYU Langone Health, recently told SurvivorNet.
Alternatives to Waiting
Those patients for whom waiting ten years isn’t an option—for those with advanced or rapidly-advancing cancers that have not responded to existing treatments on the market—may find it difficult to wrap their heads around the fact that there’s a new drug out there that could potentially help them, but they just can’t get their hands on it yet.
In those cases, patients may consider requesting access to an experimental drug through the Federal Government’s expanded access programs, “Right to Try” legislation, or else getting in on a clinical trial themselves.
“Patients who want cutting-edge therapies should be involved in clinical trials, treated at major centers by high volume physicians,” Dr. Yeo said.
Enrolling in a clinical trial can be a way to treat your cancer while helping to ensure that other patients like you can benefit from that drug or treatment down the line.
“Clinical trials hopefully can benefit you, but they can also providing very, very vital information to the whole scientific community about the effectiveness of these treatments,” Dr. Beth Karlan, gynecologic oncologist at UCLA Medical Center, recently told SurvivorNet in a conversation about clinical trials. “We need everyone to be partners with us, if we’re ever going to truly cure cancer, or prevent people from having to die from cancer.”
One More Thing…
One final thing to keep in mind when reading all the news headlines coming your way is that, if you see anything about artificial intelligence revolutionizing cancer treatment, it’s probably safe to say you have a good couple decades before those new developments impact your treatment.
“Obviously technology will improve in years to come and AI will be able to increasingly do interesting things, but I think this is years away from transforming how we treat patients,” Dr. Elizabeth Comen, an oncologist at Memorial Sloan Kettering Cancer Center, said in a conversation about Google AI for cancer research. “It’s going to take significantly more evidence and vastly more data to really change standards of care and clinical practice.”