Clinical Trial Eligibility Criteria a Growing Obstacle

Excerpt:

“Despite a decade-long call for simplification of clinical trials, the number of criteria excluding patients from participating in clinical trials for lung cancer research continues to rise.

“Researchers found a nearly 60 percent increase in exclusion criteria by reviewing 74 National Cancer Institute-sponsored lung   from 1986 to 2016.”

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For Cancer Patients, Newest Treatments Force the Ultimate Decision, with No Room for Error

Excerpt:

“Three weeks earlier she’d been done. Done with the chemo and the uncertainty and the fatigue that pinned her to a bed where her husband found her sobbing after he put the boys to sleep. “When can I just pull the plug?” she asked.

“And now Rachel Lefebvre, 43, and her husband, Fred, were here, at her oncologist’s office.

“First the doctor would tell them if a last-line chemo drug had slowed the breakaway growth of her liver tumors. It had, he said, and Fred instantly grasped his wife’s knee. Now, he told them, is the time to take their one shot at one of the most promising kinds of experimental cancer treatments, known as immunotherapy.”

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Clinical Trial Versus Standard Protocol: Why and How to Enroll in a Trial


My job at Cancer Commons is to help cancer patients better understand and make decisions about their treatment. Through our Ask Cancer Commons service, I also strive to inform patients about new drugs in trials that they can discuss with their oncologists. Sometimes, I explain the rationale behind a patient’s current or upcoming treatment, and sometimes I try to convince patients to actually get treated, rather than hope that a vegetarian diet and herbal supplements will cure their metastatic disease. Continue reading…


ASCO Calls for Cancer Trials to Include More Seniors

“In a position statement published online July 20 in the Journal of Clinical Oncology, the American Society of Clinical Oncology has called on the U.S. government and the cancer research community to broaden clinical trials to include older adults.

” ‘Older people living with cancer often have different experiences and outcomes in their treatment than younger cancer patients,’ Julie Vose, M.D., M.B.A., society president, said in a news release from the group. ‘As we age, for example, the risk of adverse reactions from treatment significantly increases. Older adults must be involved in clinical trials so we can learn the best way to treat older cancer patients, resulting in improved outcomes and manageable toxicity,’ she explained.

“More than 60 percent of cancers in the United States occur in people aged 65 and older, the statement authors say, noting the number of seniors will increase in coming years. However, there is a lack of evidence about cancer treatments for the elderly because too few are included in clinical trials, and clinical trials designed specifically for seniors are rare.”


Regrets? Opting out of Clinical Trials May Prompt More than a Few

“Women who choose not to participate in a clinical trial may be significantly more likely to later regret that decision than women who choose to participate in the study, according to a team of Penn State researchers.

“The finding may help hospitals and health researchers attract more recruits for clinical trials, a task which many physicians consider the biggest obstacle to conducting these trials, according to the researchers. Typically, as many as 20 percent of a given population of patients are eligible to participate in clinical research. However, of those, only 2 to 7 percent choose to do so.

” ‘Clinical trials are crucial, they are what we use to make discoveries in the medical field,’ said James Dillard, professor of communication arts and sciences. ‘Every time a doctor makes a directive, that information is generally based on the results of clinical trials.’

“The researchers, who report their findings in the current issue of Patient Education and Counseling, said emotions played a strong role in the decisions of women who entered a recent clinical trial. Of 100 healthy women surveyed, 72 responded that they had agreed to participate.”


ASCO Policy Statement Urges Removal of Barriers to Patient Participation in Phase I Clinical Trials

“The American Society of Clinical Oncology (ASCO) today called for greater access to and education about phase I clinical trials, the first-in-human studies of new agents designed to fight cancer.

“In a just-released policy statement, the Society stresses the critical importance of phase I clinical trials in cancer research and treatment, emphasizing that this research offers greater potential as a treatment option for many patients than was the case in the past, due to development of molecularly targeted agents, biomarker tests to identify patients likely to respond to treatments and innovative clinical trial designs.

“ ‘The Critical Role of Phase I Trials in Cancer Research and Treatment’ ASCO policy statement, which updates a 1997 version, was published today in the Journal of Clinical Oncology.

“ ‘With new agents that target specific abnormalities in a patient’s tumor, better tests to identify those abnormalities and more sophisticated clinical trial designs, today’s phase I trials in cancer offer patients a greater likelihood of benefit than ever before,’ said ASCO President Peter Paul Yu, MD, FACP, FASCO. ‘Patients shouldn’t shy away from phase I trials and doctors should present these trials as options for eligible patients throughout the period of active cancer treatment, not only when all other treatment options have failed.’ ”

Note: Learn more about clinical trials, and explore our Clinical Trial Finders for lung cancer and melanoma.


Geography May Limit Access to Cancer Clinical Trials

“Where advanced cancer patients live affects the likelihood that they can enroll in a treatment clinical trial, a new study found.

“Fewer than 10 percent of U.S. cancer patients participate in clinical trials, the authors note.

“ ‘Clinical trials are the basis for the vast majority of advances in cancer care, so, the only way to move the field forward is for patients to participate in clinical trials,’ said lead author Dr. Matthew D. Galsky of the Icahn School of Medicine at Mount Sinai in New York.

“ ‘In addition, participation in clinical trials may offer patients access to a novel treatment, that ultimately goes on to markedly change the outlook for patients with the disease, but is not otherwise available outside of the context of a trial,’ Galsky told Reuters Health by email.

“Some data has suggested that patients who participate in clinical trials may have better outcomes regardless of the treatment they receive, which could be due to the very close follow-up, and strict guidelines, for management of patients enrolled in trials, he said.”


Culturally Sensitive, Computer-based Videos Increase Clinical Trial Awareness Among Latina Breast Cancer Patients

“Latina breast cancer patients provided with information about clinical trials in multiple ways, including a culturally sensitive, computer-based video on breast cancer clinical trials, had much greater awareness of clinical trials compared with patients who received usual-care information, according to data presented at the American Association for Cancer Research (AACR) conference on The Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved, held Nov. 9–12.

“After receiving the additional information, the proportion of Latina breast cancer patients taking steps toward participating in a clinical trial increased from 38 percent to 75 percent.

” ‘Latinos represent 17 percent of the U.S. population but only 5.6 percent of participants in National Cancer Institute treatment clinical trials,’ said Patricia Chalela, DrPH, assistant professor of epidemiology and biostatistics at the Institute for Health Promotion Research (IHPR) at The University of Texas Health Science Center at San Antonio. ‘Underrepresentation of minorities in clinical trials results in disparities of cancer outcomes and limits generalizability of the findings because researchers cannot study how minority patients respond to new treatments.’ “