2021 Update
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About 80 percent of cancer patients in the U.S. are treated outside of an academic institute by a community oncologist. Amgen has launched Amgen Community Oncology Research Collaborators (ACORC), a new initiative that will provide community oncologists the opportunity to have their patients participate in clinical trials of investigational agents from Amgen’s pipeline. (Amgen)
Authors of a new study published in JAMA Internal Medicine research found that just one-fifth of confirmatory trials for cancer drug indications approved via FDA’s accelerated approval pathway demonstrated improvements in overall survival (OS). Although improvement in surrogate measures may be acceptable for accelerated approval, confirmatory trials should verify the clinical benefits in terms of overall survival (OS) or quality of life. (Regulatory Focus)
The global clinical trials market size is expected to reach USD 6.89 billion by 2026, and one of the key drivers is the globalization of clinical trials. North America leads the market in terms of revenue share; Phase III trials are expected to dominate the market; and the oncology segment will grow the fastest. (Yahoo Finance)
Tatsiana Verstak interviews Kathy Jackson, CRA at St. Jude Children’s Research Hospital, Memphis, TN Kathy Jackson has worked at St. Jude Children’s Research Hospital for 22 years, with 15 of those years in clinical research. Her background is in Health Information Management with a Master’s in Information Systems. She has Read more
About 95-98% of new anti-cancer drugs fail phase III clinical trials. Most drugs are made to target “bulk” cancer cells, but not the root cause: the cancer stem cell. New therapies that specifically target and eradicate these cancer stem cells are needed to prevent tumors from growing and spreading, and we may then be able to turn cancer into a manageable chronic disease. (INDEPENDENT)
Catheters are used today to deliver drugs directly to tumors, but half of the drug can still escape to the rest of the body, causing side effects. Doctors treating liver cancer worked with chemical engineers to design an absorbent polymer-coated device that can be temporarily placed in the vein coming out of the liver to absorb unused chemotherapy drugs, potentially lowering the risk of side effects. (Science Daily)
According to the FDA, nearly 50% of investigational new drug applications excluded patients with mental or psychiatric disorders. Should cancer clinical trial eligibility regarding mental illness be relaxed? One viewpoint is that we should relax enrollment criteria and avoid unnecessary exclusion of patients with serious mental illness. (Healio)
The National Cancer Institute (NCI) has revised its clinical trial protocols to expand access for previously excluded patients. The revisions expand access for potential participants with preexisting conditions in 4 categories, and patients under the age of 18 years. (OncLive)
A new study found that physicians were less likely to offer clinical trial participation to patients with a comorbidity. The American Society of Clinical Oncology (ASCO), Friends of Cancer Research, and the FDA recently reviewed the comorbid conditions that are generally used in eligibility criteria to exclude patients, and recommended that many be modified or liberalized, which could be necessary to improve study participation. (MEDPAGE TODAY)
The biopharma industry is on the precipice of making personalized medicine a reality with access to massive amounts of data, computing power, and artificial intelligence to run in silico clinical trials, says GNS Healthcare CEO. (outsourcing-pharma.com)