Early human-factor studies can address many questions on usability before combination products enter clinical testing, according to John Towns, a senior research fellow at Eli Lilly & Co.
The FDA expects sponsors to demonstrate that iterations of device components have no impact on the delivery of a drug — for example, in prefilled syringes and auto-injectors under development — and human factors and ergonomics studies can help deliver that evidence, Towns said during a presentation at the Joint Regulatory Conference of the FDA and the Parenteral Drug Association in Washington, D.C.
While the design and materials of the primary drug container and closure may remain identical through the product’s development, changes in handles, needle guards and even labeling will need to be shown to have no adverse impact on the patient.
“You will be iterating the device all the way through marketing,” Towns said, and each iteration should be using human factors information as evidence.
In addition, by timing human factor studies before pivotal clinical trials, sponsors can assess that a combination product will perform as intended in a Phase III study, and will be representative of a commercial product, Towns said. When human factor studies are performed after, care has to be taken to not invalidate previous studies.
“By using human factors throughout the development process, you can lower risk by reducing the number of use errors,” added Shannon Hoste, who leads the human factors team at CDRH’s Office of Device Evaluation.
Human factor validation studies can feature simulated- or actual-use environments. In actual-use environments, real drug, and not a placebo, is used in the evaluation of the user interface and critical tasks, according to FDA draft guidance. — Conor Hale