Better stress management and coping abilities have been noted in those professionals who have undergone mindfulness training. This increase in resilience can help project managers lessen the negative impacts of their demanding jobs.
Revolutions of the “way things are” vs. “the way things should be” sort are happening everywhere in the clinical research enterprise—for example, in trial designs and technologies, in workforce training and development, in regulatory compliance, in data management, and in patient recruitment and retention.
In vitro diagnostic devices are regulated as medical devices in the United States, but the obligations to demonstrate diagnostic test reliability involve some unique study designs and study implementation technicalities worth reviewing.
Expert contributors to the forthcoming February 2023 issue of ACRP’s Clinical Researcher journal caution that careful planning for patient retention efforts are still necessary to reap the benefits of recent, promising trends.
ACRP urges the FDA to, among other things, pay close attention to the intersection of parents’ and children’s rights when seeking consent or assent to participate in a clinical investigation.