How does a site become irresistible to Sponsors and CROs?
It’s nothing elusive or magical, according to clinical consultants Janet Ellen Holwell and Deborah L. Rosenbaum, who lead an all-day session on the topic at the Association of Clinical Research Professionals (ACRP) annual conference on Friday.
Rather, it’s about consistently executing all the usual site functions at a very high level and with a razor-sharp focus on being organized, following regulations and going above and beyond Sponsor expectations.
Preferred sites execute site operations seamlessly, from instituting and maintaining airtight standard operating procedures (SOPs) to reporting Sponsors that ask sites to perform unethical acts, to recording dates in a way that won’t be confusing to those working on global trials (e.g., 15DEC2015 instead of 12/15/15) to holding onto all study documents until a Sponsor lets the site know it can dispose of them.
What are the common denominators among sites Sponsors really prefer? Said Holwell, sites favored by Sponsors and CROs consistently have the capacity for meeting or exceeding enrollment. They meet deliverables, have strong principal investigator (PI) oversight and regularly demonstrate high quality in all operations.
Those efforts start well before a site makes contact with a Sponsor over a new study, said Holwell, but once contact has been made, it’s time to go above and beyond. For example, she suggested, sites should create their own recruitment plan for the study, even though that’s not required.
And once the study starts and you’re recruiting, always have an eye on the future, said Holwell. Keep great contact information on each patient so that after the study wraps, no patient is lost to follow up. Check in with subjects regularly during and after the study to ask how they’re doing.
Another way of going above and beyond: organize disease-centric support groups for patients, said Holwell. If you can’t do that, then point them to already existing support groups in the area.
And build a robust database as you work with subjects, she suggested. When screening for a study, ask all people — even those who don’t make it into the study due to exclusion criteria — for permission to call them about future studies.
The ACRP 2018 session, titled Best Practices to Become a Preferred Site, was interactive, and some attendees offered their best practices as well. One site manager shared that all coordinators provide business cards to PIs so they can keep them in exam rooms and offer them immediately after having the required chat with a patient they feel would be good for a study. The PI then documents the conversation on the spot.
Another attendee said doctors at his medical practice sit and scan through upcoming patient appointments to look for people who might meet inclusion criteria for upcoming studies. Then when the patient comes in, the doctors are ready to speak with them about the studies. Recruitment doesn’t happen on the fly, he said.
The session leaders emphasized the importance of robust, well thought out SOPs for site policies, contracting, site procedures and activities, and for specific studies.
Said Rosenbaum, “SOPs bring consistency; they establish who is responsible, they facilitate training, bring compliance and are part of a quality management system.”
Rosenbaum advised that sites move toward making all documents standardized, with all information flowing in a consistent manner, but keep it evolving. “The SOP is a living document, so adjust as you go, she added.
And if you’re not electronic, get there as soon as you can, said Rosenbaum.
“Electronic data capture is seen as the holy grail of research,” she said. “Its advantages are real-time data collection and real-time feedback during data entry, edit checks to avoid errors and data-like labs and ePRO are automatically downloaded.”
Noticeable success is also about the PIs and the coordinators staying in close touch, but often that’s not what’s happening. Said Holwell, though the buck stops with the PI, often it’s the coordinators who are doing most of the work, and the two entities can become siloed, even to the point where the PI and the coordinators rarely interact.
“The coordinator may fear talking to the PI, and may bury things. Don’t let that happen,” said Holwell.
Or, if it has happened already, take immediate steps to walk it back, doing everything you can to foster an open, comfortable environment between the PI and coordinator. The best first step, she said: Institute regular face-to-face meetings to go over all the studies that are underway, discussing each participant and what can be done to improve performance in each study.
As precautionary tales, Holwell outlined two cases where poor communications between a PI and coordinators resulted in the FDA banning the PI after things went horribly awry. In one example, coordinators were enrolling patients in a study when they didn’t meet inclusion criteria. The coordinators were even enrolling employees of the site. The PI had no idea. In the other example, a coordinator was falsifying data and fabricating patients for an HIV study. The PI wasn’t paying any attention to the study, so the falsifying went undetected, as did the fact that the coordinator was a convicted felon. In this case, the coordinator and PI were both charged with falsifying clinical trial data.
In both cases, the PIs “didn’t go back and check everything these coordinators had their hands on,” said Holwell. “Where was the oversight? Who was checking? Not the PIs.”
Holwell also used the example to reinforce that PIs should work very hard to hire well, making sure to do background checks on coordinators.
Once your site is hitting all its self-made marks on quality, it’s time to sing your praises to Sponsors and CROs, said Rosenbaum.
“Razzle dazzle them by being prepared and emphasizing your site’s strengths,” she said, adding that Sponsors look favorably on sites that are very responsive, beginning with the feasibility questionnaire.
By ready to showcase metrics from your site highlighting successful audits and recruiting triumphs, and let them know you’re happy to work with a central/commercial IRB.