The U.S. FDA’s formal evaluation process for medical devices looks at safety and efficacy prior to market clearance. Should economic considerations be added as part of the FDA review? Authors of this editorial claim that you can’t gain a complete picture of the comparative performance of a procedure by focusing on health outcomes alone; you also need to examine costs in relation to the outcomes to show cost-effectiveness. (DIAC)
The American Society for Clinical Oncology (ASCO) has released a new policy statement, “Addressing Financial Barriers to Patient Participation in Clinical Trials”, which makes several recommendations to address financial barriers to trial participation. Among other recommendations, the statement recommends improving payer clinical trial coverage, and transparency regarding out-of-pocket costs. (Healio)
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 inaugural Festival of Biologics USA is landing in San Diego on March 4th -5th 2019 (pre-conference day on March 3rd), and we want to make sure you know everything there is to know about this brand-new event.
The Festival of Biologics USA will be combining three high-level commercial events: The Americas Antibody Congress, The Word Immunotherapy Congress, and Clinical Trials USA, under one roof, with 200+ speakers, 600+ attendees and 60+ sponsors and exhibitors.
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)
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)
Chinese scientists have been forging ahead in experimenting with gene-editing on humans in the last few years, using a powerful tool called Crispr-Cas9 to edit the DNA of dozens of cancer patients. However, no federal body is overseeing these trials in China, and at least one such trial has lost touch with patients whose DNA was altered. Long-term followup of these patients is essential because unintended consequences of gene therapy could surface years later. (The Wall Street Journal)
Women have seen deficits and gains in their attempts to be included in clinical research, but as 2019 approaches equality seems forthcoming. (Outsourcing-Pharma.com)
Senior Director at Cytel believes that artificial intelligence and machine learning are going to change the clinical development paradigm, but there are challenges to overcome before AI and machine learning will be useful in clinical trials. Challenges include availability of data and the opinions of pharmaceutical companies and regulators. (Clinical Informatics News)
“Although pharmaceutical companies spend over $172 billion on research and development annually, over 90% of molecules discovered using traditional techniques fail in human clinical trials.” AI may be the “Deux ex Machina” in the field of pharmaceutical R&D. Deep Knowledge Analytics publishes their list of AI companies that are solely dedicated to scientific R&D. (Forbes)