Last year I organized a panel on the difficulties that human factors researchers sometimes have getting access to healthcare facilities. After the symposium, I summarized the results in this blog post. We also wrote a paper (pretty much a complete transcript) that was published in Proceedings of the 2017 International Symposium on Human Factors and Ergonomics in Health Care in June 2017 (HFES membership is required to view, but you can contact me).
One of the 'next steps' from the panel was, “Consider approaching the FDA about publishing a guidance document on the importance of conducting user research in clinical settings.”
Well, the good news is that the FDA has indeed published a report on the importance of observational research, titled Observational Studies: Challenges and Opportunities for Drug and Devicemakers. The report is based on a webinar given by Jeff Trotter, a 30-year industry veteran, using data from a survey of 2,500 people. Topics include:
The most effective uses of observational research in both pre-approval and post-market phases.
Using observational studies to establish baselines of real-world behavior and identify user needs.
The importance of establishing SOPs specifically for observational studies, rather than adapting clinical research procedures.
How the FDA's view of observational research is evolving.
Unfortunately, the report costs $395. Another option is to purchase the transcript from the webinar, Observational Research: Gathering Evidence in the 21st Century for $287.
For those who are new to the topic, also consider purchasing AAMI/TIR51:2014, Human factors engineering – Guidance for contextual inquiry.