Sites and Sponsors Streamlining Qualification Efforts with Technology, Process Revisions
Sites and sponsors are working toward improving the site qualification process, which is cumbersome, time-consuming and can be costly. Solutions range from data-driven technological tools for sharing information to paring down feasibility processes.
Site qualification can take up to 30 percent of a trial’s timeline, and much of the work is repetitive and an inefficient use of a site’s resources. But by standardizing the information sponsors ask for again and again and locating it in a central hub, sites are broadening their reach and attracting more sponsors with less effort than they’ve had to exert in the past.
The Shared Investigator Platform (SIP), developed by Cognizant in collaboration with several large pharma companies, is a cloud-based system that allows sponsors to search for sites and also provides a secure space for stakeholders to exchange documents and information about clinical studies.
Richard Dima, director for clinical research at Northwell Health, said SIP can quickly link sponsors focused on a particular area of study with sites based on information entered into the platform by investigators. The system is also an especially valuable tool for sponsors and sites that aren’t familiar with one another. “It’s a step in the right direction, especially since COVID-19,” he said. “I’m hoping these platforms can be utilized even more. Yes, there’s always going to be that need to reach out here and there, but that’s a lot less than the entire process put together.”
Other companies are also developing digital solutions. Diane Carozza, vice president for clinical strategic solutions at WCG Clinical, said her team is developing a new feasibility tool that will allow for data-driven identification of sites. She said the company’s proprietary WCG Knowledge Base system will help clients “make informed decisions about the investigators that we’re sending feasibility surveys to.”
“In doing so, we’re able to reduce the number of questions that we’re asking of those investigators and almost do a prequalification [visit] before we even send the survey to them,” Carozza told CenterWatch Weekly. “We can do that because of the extensive depth of historical performance information and experience information we have on these investigators.”
But some sponsors are taking a different strategy to reducing site burden with feasibility. For example, Pfizer has internalized the feasibility discussion. “We’ve been enabled with technology and tools that have really helped to enhance the feasibility process,” said Mary-Anne Tomas, director for site intelligence and selection at Pfizer. She said internalization “has allowed us to really take a closer look into utilizing some of the data sources that are available to us and allowing us to pare down some of the questions that we are asking during the feasibility process and make the process less cumbersome for sites.”
Elizabeth Weeks-Rowe, a clinical research training consultant, has seen some developments in the kinds of questions asked in the site qualification process in recent years, especially in the area of digital and technology capabilities needed to collect patient-reported outcomes. “Data collection is becoming more patient-centric,” she told CenterWatch Weekly, “and there is more emphasis on technology.”
FQs have evolved over the years, she said, to include questions about a site’s digital and technical capabilities. “Sites have to have good internet and savvy patients for some of these PROs (participant-reported outcomes) coming from e-diaries,” she said. “Data collection is becoming more patient-centric.”
Peter Fredette, strategic site networks director at IQVIA, said standardizing feasibility questions to sites is next to impossible. “So many providers and systems and tech developers have tried,” he said. “I’ve personally seen at least 20 different versions of portals from CROs, sponsors and tech providers that aim to standardize and reuse that type of feasibility information.
“I can tell you that once that information is collected, sponsors aren’t going to share it. There’s no incentive for them to do so. If any standardization and broad implementation comes to us in the feasibility space, it will come from a grassroots and site-led movement.”
Meanwhile, the time sites can save filling out multiple FQs is not to be underestimated, according to Amanda Wells, business development manager at Boise, Idaho-based Injury Care Research. Wells said she fills out at least two FQs a day, a process that takes at least 90 minutes for each document. “They’re long and there are a lot of questions,” she said. “And you can’t just re-use the one you filled out yesterday, they’re all specific.”
Lauren Kingston, associate director for clinical trial initiation at EQRx, said sponsors sometimes forget “how much sites are inundated with our technology solutions. It’s really important that we offer sites an opportunity to communicate back with how it’s going.”
Having a single document that outlines all of its capabilities, whether housed on a cloud-based platform like SIP or kept on file at the site, makes the process easier for both site and sponsor. Wells said that sponsors all ask the same basic questions for the most part; being able to hand over a document that answers those questions leaves more time for discussion of a trial’s specifics.
Weeks-Rowe concurs. Having information typically requested in an FQ contained in a single-page document, “will cut out a chunk of the evaluation and leaves more time to talk about the more important stuff like recruitment” and examining the site’s facility. It is also helpful for sites to provide information on their SOPs, especially for drug transport, informed consent and safety reporting, she said.
While not necessarily a new idea, it doesn’t appear to be a common practice and should be, she said. “Sites can do that and it’s very helpful. Great sites did that for me.”
Sites also should expect CRAs to look into their protocols, their schedule of assessments and their visits to identify what will ultimately be needed for a trial’s success, Weeks-Rowe said. She performs such an analysis before sending a confirmatory email to a site outlining what will be discussed during a site visit, how much time the process will take and what information will be needed to confirm the site for the trial.
“That is something that CRAs can do ahead of time,” she said. “You can’t just give [sites] a generic template.” She added that she sends such emails at least one week before an on-site visit — currently an impossibility due to the pandemic — and four or five days before a virtual visit. “That way, the CRC is aware of who needs to be on the call or what information you need to discuss.”
The pandemic may have forever changed the way sponsors conduct qualification visits. Before the global health crisis, Weeks-Rowe said she would typically travel the country to conduct two or three qualification visits a week. Video conferencing platforms have replaced on-site visits for now because institutions aren’t allowing visitors on-site, she said.
Based on her own observations and conversations with colleagues, she predicts that once the pandemic ends, “we’re going to be going back to some on-site visits. But institutions are realizing that remote can work just as well sometimes. It’s less costly for everybody and it can be just as efficient.”
But Kingston said times have changed. “The real need to do [on-site visits] seems kind of archaic at this point, to keep going back and confirming the same things over and over with sites that we have these long-standing relationships with,” she said.
Dan Otap, senior alliance and partnerships lead at Genentech, concurred. “When everything goes back to a ‘new normal,’ prestudy site visits, in a lot of ways, are just going to go away,” he said. “It’s the sponsor’s responsibility to vet sites, but there’s a lot of fluff that I don’t think is going to be permitted any longer. And I think we can use COVID-19 as a way of helping push that forward.”