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Medscape - Clinical Trials Too Often Exclude 'Real-World' Cancer Patients

Unnecessarily restrictive criteria for clinical trial participation excluding those with comorbidities excludes many "real-world" cancer patients and prevents them from potentially benefiting from new treatments, say cancer researchers.


Modernizing clinical trial eligibility criteria would significantly expand the pool of patients who could participate in such trials across a variety of cancers, they suggest.


These comments come from an article published online January 10 in JAMA Oncology.


GenomeWeb - Tumor Mutation Burden Predicts Immunotherapy Benefit Across Cancers, Though Cutoffs Differ

Cancer patients with high tumor mutational burden who were treated with immunotherapy tended to live longer than those with fewer mutations, researchers at Memorial Sloan Kettering Cancer Center reported in Nature Genetics this week.


American Journal of Managed Care - Comorbidities Impede Clinical Trial Participation Among Patients With Cancer

Clinical trial participation is crucial for drug development, but it’s estimated that just 5% of patients participate in clinical trials. While institutional factors, such as lack of a locally available trial, play the largest role, patient characteristics also pose barriers to participation. According to a study published in JAMA Oncology, patients with comorbidities are less likely to have clinical trial discussions with their physicians, have trials offered to them, and participate in them.


MedPage Today - Relax Comorbidity Criteria in Cancer Trials?

As efforts are being made to improve enrollment in cancer trials, a new study found that physicians were less likely to even discuss or offer clinical trial participation when patients had comorbidities.


Among over 5,000 cancer patients surveyed, 37.2% of those with at least one comorbid condition had discussions about clinical trials compared with 44.1% of those with no comorbidities (OR 0.86, 95% CI 0.75-0.97, P=0.02), reported Joseph M. Unger, PhD, of Fred Hutchinson Cancer Research Center in Seattle, and colleagues.

STAT - New study points to best way to assess which cancer patients immunotherapy will help

Experiments involving just a few patients have hinted at it, and research on one type of tumor at a time has supported it, but a large study has now delivered the strongest evidence yet about how to identify cancer patients who are likely to benefit from a particular form of immunotherapy: count.


Healio - Modernized trial eligibility criteria aim to remove comorbidities as a barrier to enrollment

Patients with cancer and comorbidities are routinely left out of clinical trial discussions, offers and participation, according to results of a study published in JAMA Oncology.


At least 60% of trial eligibility exclusions are related to patient comorbidities or performance status, according to study background.


Those statistics could start to change because of the implementation of new eligibility guidelines for clinical trials, due in part to this and other studies.


Fred Hutch News Service

How do you make cancer clinical trials available to more patients?


A new study published today in JAMA Oncology and led by Dr. Joseph Unger at Fred Hutchinson Cancer Research Center offers a tantalizing solution: loosen up the strict eligibility criteria. 


Pink Sheet - Breakthrough Denial Doesn't Mean US FDA Won't Bring Full Resources To Application

Executive Summary

Agency staff discuss how they offer early development advice to sponsors before a breakthrough decision is made and reassure them if the status is denied.


Sponsors may desire breakthrough status because of the perks that come with it, but US FDA officials said promising non-breakthrough products also could receive a lot of attention to speed them to market.


Billy Dunn, director of the Office of Neurology Products, said his staff does not approach an application differently whether or not it obtains breakthrough status.


Pink Sheet - 340B Payment Cut Overturned By US Federal Court; What Comes Next?

Executive Summary

Siding with coalition of hospitals, judge ruled that HHS lacked authority to cut Medicare reimbursement for drugs purchased at 340B prices. That should change the dynamics of the 340B reform debate heading into 2019 – but don’t expect the Trump Administration to back down on its push to rein in what it sees as abuses of the discount.


Pink Sheet - External Control Arms: Better Than Single-Arm Studies But No Replacement For Randomization

Executive Summary

Synthetic control group derived from historical clinical trial data could augment smaller randomized trials and yield better information than single-arm studies, but this approach should not be viewed as a substitute for randomized trials where feasible, US FDA officials said at a Friends of Cancer Research meeting.