Note: The HUB is a combined effort between UCSF's Office of Research, the Office of Ethics and Compliance, and CTSI.
By Jeffrey Norris
When it comes to clinical trials, many patients know little about what it means to participate. Physicians and researchers who seek to advance medical treatment and who hope to inform patients who have few other options about promising but unproven treatments have long lamented this learning curve.
But for those same physicians and researchers — as with their patients — learning all they should know about studies that include people as research subjects can be challenging. Even the best trained in their fields can lose time and miss steps trying to learn about, remember and locate all the information needed to conduct a clinical trial and comply with an increasing number of regulatory requirements for trials that involve human subjects.
Now a new web portal launched by UCSF earlier this year offers researchers, study coordinators and study participants an easy-on-the-eyes, logically arranged and comprehensive tool that will guide them to a wealth of much-needed information.
A researcher wondering whether she needs to submit an Investigational New Device Application (IND) to the U.S. Food and Drug Administration (FDA), a study coordinator preparing for an audit, a patient looking for a clinical trial or trying to figure out what it means to participate in such a trial, or a potential industry collaborator wanting to know how to partner with UCSF researchers can all benefit from using the website.