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)
Drug sponge could minimize side effects of cancer treatment
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)
Trials exclude patients with mental or psychiatric disorders
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)
National Cancer Institute expands eligibility criteria for trials
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)
ASCO, FDA recommend relaxing cancer trial eligibility criteria
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)
How in silico trials are making personalized medicine a reality
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)
Bureaucracy contributes to “devastatingly slow” cancer clinical trials
Oncologists are starting to look at bureaucratic obstacles that contribute to the “devastatingly slow” pace of cancer clinical trials. Bureaucratic disqualifications and barriers contribute to low clinical trial participation; in Europe, regulation dramatically increases trial cost and time; and “misguided” use of IRBs contributes to study delays. Outsourcing to CROs reduces study startup times. Higher trial costs, in turn, contribute to higher drug costs. (Medscape)
Genetic component is complicating clinical trials, esp oncology
Genetics are playing a growing role in clinical trials, as more therapies in development are targeted to the underlying cause of a disease. Nearly half of all therapies in clinical trials, and 73% of oncology trials, are collecting biomarker and genetic data. Adding genetic testing can complicate a study, and the authors recommend that sponsors provide trained genetic counselors as a resource to their investigators. (MedCityNews)
FDA provides Guidance on oncology endpoints
This December 2018 guidance from the FDA discusses how different oncology endpoints can serve different purposes depending on the context, and provides the agency’s recommendations on which endpoints are to be considered in several different contexts. (Regulatory Focus)
Clinical trials underestimate adverse events associated with immunotherapies
www.specialtypharmacytimes.com
An analysis of adverse events (AEs) associated with immune checkpoint inhibitors based on insurance claims suggests that the frequencies of immune-related AEs may be higher than reported in trials that led to the FDA approvals for immunotherapies. The researchers suggest that real world data could refine our expectations for outcomes beyond what is reported in clinical trials. (Specialty Pharma Times)