Regulatory expert Marlene Berro — with support from across UCSF — developed a new web portal that serves as a go-to resource for researchers, study coordinators and study participants about clinical trials and has introduced it to small groups of users through on-campus demonstrations.
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.
Early Website Reviews Are Positive
In the past, information needed by researchers and study coordinators largely existed online on various UCSF web pages. Finding it in many cases could defy search efforts, says Marlene Berro, MS, RAC, a regulatory expert who consults on special projects at UCSF and who also is the campus administrator of ClinicalTrials.gov, a national registry and results database of federally and privately supported clinical trials conducted in the United States and internationally. Now resources, expertise, and guides to best practices for investigators and research staff to conduct and manage research efficiently, compliantly and ethically are gathered in one virtual place — UCSF's Clinical Research HUB — with all the information just a click or two away.
“I feel so fortunate to have discovered the HUB early in my UCSF career, and I think it has made my transition into the role of study coordinator a smooth and painless one,” says Sarah Lind Hall, MA, clinical research coordinator for sports medicine studies at the UCSF Orthopaedic Institute at Mission Bay. “Complicated processes such as protocol creation or an FDA Investigational Device Exemption are translated into simple, easy-to-follow steps.”
For research participants, resources include a clear overview, and lists of important questions to ask caregivers and study coordinators about clinical trials and other research studies. There are links to clinical trials at UCSF and beyond.
Value Extends Far Beyond UCSF
And while the portal was designed for UCSF, where there were 5,269 active studies involving human subjects in 2011 — according to data obtained from the Human Research Protection Program at UCSF — the website should be equally useful to investigators outside of UCSF, Berro says.
Berro — with support at UCSF from the Clinical and Translational Science Institute (CTSI) Office of Clinical Research Services, the Office for Research and the Office of Ethics and Compliance — developed the website in consultation with UCSF Information Technology Services over the past six months, and has introduced it to small groups of users through on-campus demonstrations.
In addition to relying on her knowledge of existing resources, research requirements and best practices, Berro was guided in part by analysis of search attempts made by those trying to access information on various UCSF websites.
“For the most part we leveraged existing content, and put it into one easy-to-find format,” Berro says. But she also worked with UCSF faculty and staff to create new content. The additions cover topics related to trial management, regulatory compliance, and the training of scientific investigators and staff.
Joan Campagna, study coordinator for the UCSF Comprehensive Genetic Arrhythmia Program, is another early adopter. “Our program office is currently preparing for our first internal audit, and the HUB has become a daily companion,” she says. “Having one place to turn to that provides end-to-end guidance over the ‘lifecycle’ of a study, with links to all kinds of ancillary information, is a powerful tool.
“I also find the organization and navigation on the site to be clear and useful, and well-linked to other sources of information. I have no doubt that I will use this site on an ongoing basis, both to learn new things and to refresh existing knowledge.”
Berro envisions the web portal becoming a “go-to” resource for clinical researchers and their staffs and is committed to keeping the information updated. Planning for the second phase of implementation — which will include a consent builder, electronic FDA submissions, and the automation of ClinicalTrials.gov protocol registration — is in the works, she says.
“Those who are doing clinical research can get the answers to most of their questions. If people can’t find what they need, they should let us know.”
Photo by Susan Merrell