Structural and Clinical Barriers Keep 3 of 4 Cancer Patients from Participating in Trials

Excerpt:

“A new meta-analysis led by Dr. Joseph Unger of Fred Hutchinson Cancer Research Center has revealed that structural and clinical barriers prevent more than 3 out of 4 cancer patients from participating in clinical trials.

“The study is part of an ongoing effort to understand why patient participation is so low in cancer clinical trials. Unger, a health services researcher and biostatistician who focuses on disparities in cancer research, published his findings today in JNCI, the Journal of the National Cancer Institute.”

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Marty Tenenbaum to Speak at Bridging Clinical Research & Clinical Health Care Collaborative

Cancer Commons founder Marty Tenenbaum, PhD, will speak at the upcoming Bridging Clinical Research & Clinical Health Care Collaborative at the National Academy of Sciences in Washington, DC, on March 4 at 5:00 pm. Marty, who founded Cancer Commons after his own battle with melanoma, will facilitate an expert panel discussion on “Reinventing Clinical Research and Cancer Care.” That same day, he will also lead a lunchtime discussion on “Shifting the Clinical Trials Paradigm From Approving Drugs to Curing Patients.”

In preparation for the conference, Marty has written a piece for Bridging Clinical that outlines his take on the increasing demand for patients in clinical research. An excerpt: “Those familiar with the current drug development process express skepticism that the system can ever be changed — and for good reason; many have tried and failed. However, a confluence of trends, from patient activism to the explosion of new therapies to an unprecedented open regulatory environment, make a paradigm shift from drug-developer-centric to patient-centric trials both necessary and possible.” Click here to read the full article.

Learn more about this event at https://www.bridgingclinical.com/.


ASCO and Friends of Cancer Research Applaud NCI’s Expansion of Clinical Trial Eligibility Criteria

Excerpt:

“ASCO and Friends of Cancer Research (Friends) applaud the National Cancer Institute’s (NCI) recent revision of its clinical trial protocol template to broaden eligibility criteria for cancer clinical trials. The protocol template was expanded to help increase the opportunity for participation in NCI-funded clinical trials for patients with certain health-care conditions, as well as to provide an opportunity for patients younger than age 18 to participate in adult clinical trials in certain circumstances.”

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ASCO and Friends Submit Recommendations to FDA Aimed at Reducing Barriers to Clinical Trial Participation

Excerpt:

“ASCO and Friends of Cancer Research (Friends) have submitted recommended language to the U.S. Food and Drug Administration (FDA) for five guidance documents on ways to broaden eligibility criteria for cancer clinical trials. The recommendations are part of an ASCO and Friends collaboration to broaden eligibility for participating in clinical trials by addressing five specific areas: minimum age requirements for trial enrollment, HIV/AIDS status, brain metastases, organ dysfunction, and prior and concurrent malignancies.”

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New Guidelines on Clinical Trial Design for Patients with Brain Metastases

Excerpt:

“Clinical trials of new anti-cancer therapies have often excluded patients whose disease has spread to the brain or central nervous system (CNS) or, if such patients were allowed on trial, trials have often failed to clearly capture information on the drug’s effect in the brain. Today new guidelines from an international, multidisciplinary group published in the journal Lancet Oncology describe how to most appropriately address cancer patients with CNS involvement within clinical trials of anti-cancer drugs.”

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Cancer Clinical Trials Exclude Many Desperate Patients. Should That Change?

Excerpt:

“When 29-year-old Carly Bastiansen was diagnosed in January 2016 with advanced pancreatic cancer, doctors told her a clinical trial was her best shot at slowing the notoriously quick-killing and hard-to-treat disease. She found one that appeared promising and went through the screening process. But the trial would not accept her.

“ ‘Participating in a clinical trial is really my only chance at living longer,’ Bastiansen, a children’s librarian in Baltimore, said this fall as she was growing weaker. ‘To have had that option taken off the table was devastating.’ ”

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Expert Says Melanoma Clinical Trials Should Include More Patients With Brain Mets

Excerpt:

“Historically, patients with melanoma who develop brain metastases have been excluded from clinical trials, according to Harriet Kluger, MD.

“As of late, an increasing number of patients in this subgroup are being included now on studies, particularly those who have received prior treatment. Yet this is still not enough, says Kluger, as brain metastases is no longer the dismal prognosis that it once was.”

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Study Questions Exclusion of Cancer Survivors from Trials

Excerpt:

“A quarter of newly diagnosed cancer patients 65 or older are survivors who had a prior cancer — often preventing them from participating in clinical trials, researchers from UT Southwestern’s Simmons Cancer Center have found.

“The UT Southwestern scientists found that 11 percent of individuals ages 20-64 had a history of a prior cancer, and 25 percent of individuals 65 or older had a history of a prior cancer.

“As the number of cancer survivors grows, more individuals are being excluded from cancer clinical trials that could benefit them when diagnosed with a second cancer.”

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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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