January 22, 2018
The Senate Finance Committee advanced the nomination of ex-Eli Lilly exec Alex Azar to serve as HHS secretary, by a mostly party-line vote of 15 to 12. He is expected to be confirmed by the Senate as a whole in the coming weeks. “Mr. Azar is well-credentialed to lead such a critical department at a time America’s healthcare system is facing difficult challenges,” said committee chair Sen. Orrin Hatch (R-Utah). Sen. Tom Carper (D-Del.) was the lone Democrat in favor. Much of Azar’s confirmation hearings focused on the rising price of drugs, especially during his tenure as president of Lilly USA, with Azar himself agreeing that prescription costs are too high. Many Republicans touted his industry experience as a positive, saying he would an insider’s perspective to the role.
FDA and DoD Unveil Medical Product Research Program
The FDA and the Department of Defense announced a joint program to prioritize development of medical products for deployed military personnel. Under the program, the DoD’s Office of Health Affairs and the FDA will collaborate in reviewing products meant to treat, prevent or diagnose serious or life-threatening conditions for troops, and accelerate development of the products. Given the ethical problems with testing products for anthrax, botulism and acute radiation syndrome on human subjects, the “Animal Rule” permitting approvals where traditional clinical trials are not feasible has been key to at least 12 product approvals, according to FDA Commissioner Gottlieb, during a Senate health committee hearing on medical countermeasures. The FDA will also begin issuing priority review vouchers for countermeasures that have not been previously approved for another indication, under a provision of the 21st Century Cures Act, according to a new agency guidance.
Oracle Survey Polls Challenges for Implementing Digital Trial Management Systems
A new survey described the main challenges for clinical trial professionals using current randomization and trial supply management and interactive response technology systems — with over 70 percent of respondents pointing to a lack of flexibility, integration with other platforms and the time burden it takes to deploy new trials as their major frustrations. The online survey, conducted by Oracle Health Sciences and Informa Engage, found that 92 percent reported having to make changes to their RTSM/IRT systems due to study changes, and at least twice per study on average. The most anticipated change in the next five years is the integration of IRT into the platform, followed by accelerated trial builds and self-service solutions, according to the study, which polled 254 professionals in clinical operations, trial management and related areas.
New KMR App Offers International Site Contract Time Benchmarks
KMR Group launched its Site Contracts Application, which encompasses milestone information from over 100,000 clinical contracts in nearly 100 countries, and assesses pharmaceutical industry site contract cycle times. The application provides previously unavailable benchmarks, based on disease and location, to help companies reduce their cycle times, the company said. The system is based on Phase II and III contract milestones from drugmakers and contract research organizations. The tool can also help compare contract performance by study phase, type of site and budget cycle time. Over 20 companies are represented in the application.