FierceBiotech - CRO ASCO and Friends push for more cancer patients in COVID-19 vaccine trials
Vaccines are critical to curbing the ongoing COVID-19 pandemic, but cancer patients have largely been left out of clinical trials testing the efficacy of such treatments.
That must change, the American Society of Clinical Oncology (ASCO) and Friends of Cancer Research say in a joint position statement (PDF).
There needs to be more data around how COVID-19 vaccines affect people with cancer, or those with a history of cancer, so that the approximately 1.9 million people in the U.S. who will be diagnosed with cancer this year know the effectiveness and safety of such treatments. On a global scale, there were about 19 million new cancer cases last year, showing just how large this patient population is.
ASCO and Friends claim cancer patients have been "almost universally excluded" from participating in clinical trials for the vaccines meant to treat SARS-CoV-2. Cancer patients are more susceptible to the virus and need a better understanding of how the vaccines will impact them, the groups say.
"It is critically important to study adequate numbers of patients who have cancer or a history of cancer so that we can better understand the degree to which patients with cancer, various kinds of immunocompromise, or both respond to vaccines," said Everett Vokes, M.D., president of ASCO, in a statement.
Homogenous patient populations "may have been preferable" toward the beginning of the rapid vaccine development into which the U.S. and other countries poured billions of dollars, but, with multiple jabs already granted emergency use authorization, it is beyond time to include cancer patients, ASCO and Friends argue.
While the U.S. ramped up its vaccination effort rather quickly, the country is likely to fall short of the Biden administration's goal of getting 70% of adults at least one jab of the vaccine by July 4.
In a study published Tuesday in JNCI Cancer Spectrum, 37.1% of 342 adolescent and young adult cancer survivors surveyed said they had COVID-19 vaccine hesitancy. The American Cancer Society says "many expert medical groups recommend" the vaccine for most cancer patients, or those with history of cancer, with the suggestion of discussing it with their doctors.
ASCO and Friends recommend vaccine manufacturers and trial sponsors prioritize cancer patients in their recruitment efforts by partnering with oncology practices, cancer centers, academic medical centers and others. Government agencies should also encourage and incentivize these manufacturers, they add.
“We need to find an optimal balance between improving patient access to clinical trials and the methods used for robust evaluation of safety and efficacy of new therapies," said Jeff Allen, Ph.D., president and CEO of Friends, in a statement.
Beyond the clinic, real-world data on how cancer patients respond to the vaccines should be collected and analyzed by public health agencies and researchers, the groups say.
This is critical, as oncologists need more information to adequately treat their patients, ASCO and Friends write in their statement. Ideal timing between therapy cycles, length of waiting periods after stem cell transplants and immune globulin therapy and other specifics remain unknown.
One bright spot: Currently approved COVID-19 vaccines do not contain live viruses, which is usually a deterrent to patients with cancer because vaccines with live viruses pose a "potential risk of viral transmission with subsequent infection in those with compromised immune function."