Some of the clinical research coordinators (CRCs) were doing their work sitting on the floor. Others were reduced to conducting their monitoring in a stairwell.
As a sponsor, Jane M. Jacob, PhD and VP, research and clinical affairs with device-maker Orthofix, Inc., wasn’t exactly impressed. “I passed them by,” she said. Sites that don’t have standalone space for CRCs “are telling me something” and it isn’t good, she told attendees of the session “Practical Strategies for Building Lasting Relationships Between Sponsors and Sites,” at the Association of Clinical Research Professional (ACRP) 2018 Conference at the Gaylord National today.
Jacob and Marcus B. Stone, PhD and director of clinical research with the Spine Institute of Louisiana Foundation, shared their perspectives as a sponsor and site, respectively, to a standing room only audience.
“There are similar expectations on both sides,” Stone said. However, it’s important for each entity to understand the other, both stressed.
Sponsors and CROs have a wish list for dealing with sites, Jacob said. Items include:
- One or two persons should be the main contact. “It’s hard for me to remember who is responsible for what” if there are too many people involved in the give and take of information, Jacob said.
- Sites should be more proactive when they are unsure about what to do. “We love questions,” she said. When a site reaches out “at least we know they are thinking about the protocol.”
- On the other hand, don’t send out emails for every issue. “While there’s no such thing as a dumb question,” Jacob said, it can be irritating if a site repeatedly sends queries about things covered in the protocol or trial toolkit.
- Timely return of phone calls and emails. That said, sites shouldn’t feel compelled to send a quick kneejerk reply. “It’s okay to say you are totally swamped and will get back to me later,” she said.
Stone offered a critical, and perhaps counter-intuitive, piece advice to sites: Try not to let yourself get swept up by the exciting potential of a drug or device. It’s tempting to be involved in that kind of trial, but if a site detects red flags, take a long hard look before accepting the trial.
When assessing a site, Jacob examines the obvious qualifications, such as infrastructure and resources. However, she also looks at the sites team in its entirety. “Doctors and PIs are mandatory, but if a site doesn’t have enough CRCs actually doing the work, I’ll pass them by.”
Author: Michael Causey