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Underenrollment in clinical trials: Patients not the problem

In Clinical Trials by Barbara Jacoby

By: UT Southwestern Medical Center From: medicalxpress.com The increasing sophistication of cancer treatments threatens to outpace the ability of health care providers to enroll patients in clinical trials to test those therapies. That’s a key finding by researchers in UT Southwestern’s new Department of Population and Data Sciences. The authors of the study published this month in the Journal of …

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How sites and sponsors can support patients in clinical trials

In Clinical Trials by Barbara Jacoby

By: Kate O’Brien From: knect365.com Sites and Sponsors need to start supporting patients as soon as they have expressed an interest in joining a trial. The relationship that develops between the patient and site staff directly impacts on the experience the patient has of clinical research, the probability that they will complete the trial and their likelihood of participating in …

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The Vital Role of Imaging in Clinical Trials

In Clinical Trials by Barbara Jacoby

By: Amit Vasanji, Ph.D. , Chief Technology Officer, Imaging, ERT Inc. and Brett A. Hoover, Director of Product Management, Imaging, ERT Inc. From: pharmavoice.com Technology and innovation are reshaping clinical trials. Nowhere is this more evident than in the use of imaging in drug and device research. Over the last 10 years imaging has evolved from mostly qualitative assessments to …

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Rakuten Medical Releases Phase 2a Study Data during ASCO Annual Meeting Highlighting Positive Safety Profile and Clinically Meaningful Anti-tumor Activity

In Clinical Trials by Barbara Jacoby

From: prnewswire.com Rakuten Medical, a clinical-stage biotechnology company developing precision-targeted cancer therapies based on its proprietary Photoimmunotherapy (PIT) platform, announces positive data results from its Phase 2a study, evaluating the safety and anti-tumor activity of RM-1929 (an EGFR-targeted antibody conjugate) PIT in patients with locoregional, recurrent head and neck squamous cell carcinoma (rHNSCC). Details of its global Phase 3 study …

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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 …