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)
New FDA Guidance on “first-in-human multiple expansion cohort trials”
The FDA has published a draft guidance that provides sponsors with recommendations for designing and conducting first-in-human (FIH) multiple expansion cohort trials within their oncology development programs. The guidance defines this type of trial as “an FIH trial with a single protocol with an initial dose-escalation phase that also contains three or more additional patient cohorts with cohort-specific objectives.” (Clinical Leader)
Trends in oncology studies represent the future of clinical trials
About 80 percent of clinical trials are oncology trials. Experts shared their insights into where the industry is headed: explosive growth of clinical trials in China, growth in combination trials, use of companion diagnostics to match patients to trials, and how to design better trials that will generate the data we need with as few patients as possible. (Life Science Leader)
National Cancer Institute expands eligibility criteria for NCI-funded trials
The National Cancer Institute (NCI) has revised its criteria for NCI-funded trials to expand eligibility to individuals with pre-existing conditions, and provide opportunities for patients younger than 18 to participate in adult clinical trials. The new guidance helps to ensure that participants in clinical trials better reflect patients who will receive cancer therapies in routine clinical practice. (Health IT Analytics)
National Cancer Institute: We need to modernize cancer clinical trials
According to the director of the National Cancer Institute, an important challenge for cancer research now is modernizing the clinical trial infrastructure. Targeted therapies are changing how clinical trials are conducted, with a shift towards molecularly defined trials, which are more complicated to administer and require next generation sequencing to screen patients for enrollment with narrowly defined inclusion criteria. (BIOPHARMADIVE)
Reflections on a Career in Oncology Clinical Research
Clinical Researcher interviews Beth Cuccia, RN, BSN, MHM, on her 25 years of experience in clinical research including 15 years in oncology studies. (Clinical Researcher)
Cancer societies issue recommendations for reporting of immune-oncology trials
Photo: Peptide epitope of CD20 bound to Rituximab FAB. The American Society of Clinical Oncology (ASCO) and the Society for Immunotherapy of Cancer (SITC) have issued recommendations on Trial Reporting in Immuno-Oncology (TRIO). These recommendations are intended to improve the reporting of immune-oncology clinical trials and provide more evidence on the benefits and risks of this approach. Standardizing how trials are reported will also allow us to compare different immune-oncology trials. (cancernetwork)