Cancer drug trials too slow, patients and families say in survey
The sense of urgency surrounding the COVID-19 pandemic led to speedy development of several vaccines against the SARS-CoV-2 virus.
Operation Warp Speed — the name given to the expedited creation and adoption of vaccines for COVID-19 — has demonstrated the ability of the life sciences and health care industries to function more rapidly when faced with a public health crisis. This effort led about half of all respondents to a study sponsored by COTA, Inc. to believe cancer treatment and drug development processes can and should be faster in the future.
“This particular moment in history is magnifying the question that many people who get a cancer diagnosis ask: ‘Why does it take so long to get a drug developed?’” Gwen Nichols, MD, executive vice president and chief medical officer for The Leukemia & Lymphoma Society, said in an interview with Healio. “Conducting clinical trials is a long, complex and very safety-oriented process, but the urgency we all felt around the COVID crisis made the process move much more quickly, and we were able to cut out some of the red tape.”
The value of sharing data
For the study, researchers surveyed 1,110 Americans who have been diagnosed with cancer or were immediate family members of an individual with cancer. They found that attitudes specific to cancer care and treatment are being shaped by experiences from the pandemic. Specifically, two-thirds of respondents reported that clinical trials for cancer take too long to yield results, and more than 80% of respondents familiar with the clinical trials process erroneously believed that clinical trials include sufficient real-world data from diverse racial, ethnic and socioeconomic groups. Additionally, about 85% of survey respondents stated their willingness to share their anonymous data if requested by their physicians, and 86% believed that oncologists should talk to patients about the value of sharing data.
“What we found from this survey is that patients with cancer are very open to sharing their data if it is to help improve the lives of all patients with cancer,” CK Wang, MD, chief medical officer of COTA — an oncology real-world data and analytics firm — said in an interview with Healio. “Each patient record contains a very rich history and story, and patients with cancer believe that when their record is used in the right way, when grouped together with records of other patients, that this information can yield valuable insights.”
Nichols said patients with cancer feel the same urgency about their disease that individuals around the world felt about COVID-19.
“These patients are also not worried about safety in the same way,” she said. “When the threat is bad enough, safety becomes secondary.”
She recalled being at a meeting of the FDA’s Oncologic Drugs Advisory Committee in which safety was discussed as part of the clinical trial process for a pediatric cancer drug.
“One of the parent/advocates there said, ‘Of course we care about safety, but it’s meaningless if my kid dies of this disease before they get a chance to try this drug,’” Nichols said. “So, depending on the urgency of the issue, people are willing to take greater risks for a chance at a longer life. A lot of patients and parents of children with cancer feel strongly about that. I think it needs to be considered when thinking about the clinical trial process and how long it takes.”
According to Ankit Kansagra, MD, an assistant professor at University of Texas Southwestern with a specialty in blood cancers and stem cell transplantation, the response to COVID-19 has raised the valid question of whether cancer clinical trials can be conducted more quickly.
“In general, we think of the clinical trials process, from phase 0 to phase 4, as taking multiple years,” Kansagra said in an interview with Healio. “What we’ve seen in the COVID era, and what this study tries to delve further into, is how quickly we were able to accomplish some of these major trials. I think this really emphasizes the importance of streamlining bureaucracy.”
Kansagra discussed the RECOVERY trial that evaluated dexamethasone as a potential treatment for COVID-19.
“It was a huge breakthrough last year when we heard that dexamethasone could be beneficial for patients with COVID infection,” he said. “This clinical trial was done in the United Kingdom, and the entire study was done in a matter of 3 months. An important question is, how were they able to accomplish this?”
Kansagra credited simplified protocols and regulatory oversight with expediting findings.
“The clinical trial protocols were flexible, they were short and to the point, and a lot of regulatory agencies came and got things together,” he said. “The recruitment process was much simpler.”
Although the expedited efforts to address COVID-19 have highlighted the comparatively lengthy cancer clinical trials process, the situations are not necessarily analogous, according to Nichols.
“It’s not an easy comparison,” she said. “Cancer is not just one disease, whereas COVID-19, although there are new variants, is still the same virus and the possible clinical trial participant for COVID vaccination is anyone, in theory.”
However, Nichols said the findings from the COTA study are valuable because they show that patients with cancer are devoted to helping make clinical trials move faster.
Meanwhile, The Leukemia & Lymphoma Society is working with regulators to find the right balance of safety and statistical significance, Nichols said, adding that making trials easier to participate in — and accessible to diverse populations in terms of race and age — will be a key obstacle to transcend.
“We need to overcome hurdles,” she said. “One of the things we can do, in my mind, is to get trials, or at least part of clinical trials, closer to where the patients are.”
Kansagra added that the COTA study underscored the need for better communication with patients and the public in terms of clinical trial protocols.
“I think transparency is important,” he said. “We can put the information out there and they can see that Dr. XYZ and his team are setting up a trial, and they can see how the trial is being conducted. These protocols don’t need to be hidden.”
For more information:
Ankit Kansagra, MD, can be reached at University of Texas Southwestern, 2201 Inwood Road, Dallas, TX 75235; email: firstname.lastname@example.org.
Gwen L. Nichols, MD, can be reached at The Leukemia & Lymphoma Society, 3 International Drive, Rye Brook, NY 10573.
CK Wang, MD, can be reached at 101 Arch St., Boston, MA 02110; email: email@example.com.