January-February 2019 (Volume 20, Number 1) : pdf
FDA releases ‘master protocols’ draft guidance
The FDA has published a draft guidance for industry titled Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics. This guidance provides advice to sponsors of drugs and biologics for cancer treatment regarding the design and conduct of clinical trials, other than first-in-human (FIH) trials, intended to simultaneously evaluate more than one investigational drug and/or more than one cancer type within the same overall trial structure (master protocols) in adult and pediatric cancers. In contrast to traditional trial designs, master protocols use a single infrastructure, trial design, and protocol to simultaneously evaluate multiple drugs and/or disease populations in multiple sub-studies, allowing for efficient and accelerated drug development.
The never-ending challenge of workforce satisfaction and retention
Vows of improvement often accompany a new year. For the clinical trial sector, the top resolution could be to create a more responsive, inspiring workplace. Much has been written and cited about the challenge of workforce viability in the clinical trial sector. It is important to recognize that this issue is not unique to clinical trials. Many sectors — from manufacturing to medicine — struggle with employee satisfaction and retention.
Blame the protocol
Every year, the BMJ Christmas edition posts humorous articles to entertain its readers, such as “Parachute Use to Prevent Death and Major Trauma When Jumping from Aircraft: Randomized Controlled Trial.” This year, London researchers reviewed the reasons given by experts at news conferences to explain disappointing clinical trial results.