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Barriers to Cancer Clinical Trial Enrollment

In Clinical Trials by Barbara Jacoby

By: Andrea S. Blevins Primeau, PhD, MBA From: cancertherapyadvisor.com Clinical trials are critical to developing new therapies and improving existing regimens for better efficacy and safety.1 Clinical trials can only be conducted if they enroll sufficient numbers of patients, and the more rapid the accrual, the sooner results can be collected and analyzed, and, ultimately, translated to the clinical setting. …

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Leveraging Real World Evidence for drug approval

In Clinical Trials by Barbara Jacoby

By: Andrew Burrows From: knect365.com In 2016 the FDA introduced the 21st Century Cures Act, which allowed for the expansion of real world evidence in gaining approvals for new drugs. Following this Pfizer’s Ibrance, a CDK 4/6 inhibitor, was recently approved for the treatment of breast cancer in men by leveraging real world evidence. Whilst there are clearly exciting opportunities around the use …

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Genomic Assays Advance Personalized Care in Early-Stage Breast Cancer

In Clinical Trials by Barbara Jacoby

By: Caroline Seymour eFrom: onclive.com The collective results of the MINDACT and TAILORx trials provided a better directive in terms of whether or not to give endocrine therapy alone or in combination with chemotherapy for patients with node-negative, early-stage hormone receptor (HR)–positive, HER2-negative breast cancer, said Mariana Chavez Mac Gregor, MD, MSc. “In patients who have early-stage HR-positive, HER2-negative disease, …

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US Biopharma Company Undertakes Anti-Cancer Clinical Trials in Poland, First Patient Showing Positive Initial Treatment

In Clinical Trials by Barbara Jacoby

Moleculin quickly recruited qualified patients and started trials for two of its portfolio drugs to supplement US efforts. A small public company with 6 highly promising anti-cancer drugs in the pipeline is augmenting US clinical trials with trials in Poland, speeding the process of patient recruitment and data collection. The company, Moleculin (NASDAQ: MBRX), recently recruited 3 patients in 6 …

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Flatiron, Foundation Medicine study points to real-world data’s utility in oncology

In Clinical Trials by Barbara Jacoby

By: Alaric DeArment From: medcitynews.com Data published in JAMA on lung cancer patients treated with immunotherapy drugs, gleaned from EHRs and genomic sequencing, backs up clinical trial data and validates clinico-genomic database, the companies said. Patients with non-small cell lung cancer whose tumors carry high mutation burden and are treated with immune checkpoint inhibitors show prolonged responses to treatment and …

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SWOG’s 1501 study takes aim at the silo wall between cardiology and oncology

In Clinical Trials by Barbara Jacoby

By: Justin Floyd From: cancerletter.com Many have written and spoken about the goal of eliminating the effect of developing and delivering medical care in “silos.” Silos can simply be defined as medical or scientific environments functioning in parallel. They are independent and not often visible by those working in another silo. Silos often exist unintentionally, but have been a real …

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Strategies developed to include more racial and ethnic minorities in clinical trials

In Clinical Trials by Barbara Jacoby

Source: Medical University of South Carolina From: eurekalert.org Not one size fits all, and nowhere does that show up more than in the recruitment of racial and ethnic minorities into clinical trials, says Hollings Cancer Center researcher Marvella Ford, Ph.D. This is critically important since this population has a high prevalence of certain cancers. Ford, who is associate director of …

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New ORNL AI tool revolutionizes process for matching cancer patients with clinical trials

In Clinical Trials by Barbara Jacoby

Source: DOE/Oak Ridge National Laboratory From: eurekalert.org A team of researchers from the Department of Energy’s Oak Ridge National Laboratory Health Data Sciences Institute have harnessed the power of artificial intelligence to better match cancer patients with clinical trials. The researchers were one of ten teams to develop a digital tool to address complex challenges relevant to medical conditions such …

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NKMax America Announces FDA Approval of IND for Phase 1 Trial of SNK01 in Patients with Refractory Cancer

In Clinical Trials by Barbara Jacoby

Source: NKMax America, Inc. From: prnewswire.com NKMax America, a biotechnology company harnessing the power of the body’s immune system through the development of Natural Killer (NK) cell therapies, announced today that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application for SNK01, an autologous NK cell adoptive immunotherapy candidate for the treatment of patients …

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Patient-reported symptoms offer insight for clinical trials

In Clinical Trials by Barbara Jacoby

By: University of North Carolina at Chapel Hill School of Medicine From: medicalxpress.com University of North Carolina Lineberger Comprehensive Cancer Center researchers and collaborators found that allowing patients to write, in their own words, about treatment-related symptoms they experienced while participating in clinical trials can provide valuable information. In a first-of-its-kind study published in the Journal of the American Medical …