Sponsor, Site Priorities Don’t Match Up, More Alignment Needed in 2022
There is a growing disconnect between sponsors’ priorities for conducting trials and their operational practicality for sites. An approach that might be seen by the sponsor as perfect for a trial may, in fact, be difficult for site staff who have to implement it.
“We are still having a tremendous number of study delays. We have more data analytics than ever before, we have more vendors, more sponsors, more CROs than ever before. Why are studies still falling behind?” Suzanne Caruso, WCG’s vice president of clinical solutions, asked at the SCOPE Summit for Clinical Ops Executives last week.
“You can have the best strategy in the world, but if you can’t operationalize what it is you’re actually doing, it doesn’t matter,” she added.
Findings from trial software developer Florence Healthcare’s 2022 State of Clinical Operations report demonstrate a concerning lack of alignment on the biggest issues that sites and sponsors face, Caruso said. The survey, conducted in late 2021, included 193 respondents from sites, sponsors and CROs.
Sites’ number one priority — making sure their electronic data capture systems are operationally connected — didn’t even appear in the top eight priorities for sponsors. Sponsors named remote monitoring and quality control workflows as their top priorities, the only ones that made the top-four list of both sites and sponsors, Caruso noted.
Sites named training and credential-tracking of study staff as their third-most important priority, another area that didn’t appear in sponsors’ top eight. Sites pointed to automating regulatory tasks and startup workflows as their second-most important concerns, areas that sponsors also agreed were relatively important, ranking them fifth in their list of priorities.
Patient/participant matching with electronic medical records, consenting, remote source access workflows and site selection/feasibility all tied for fifth place among sites.
For sponsors, patient recruitment appeared in second place, site adoption of new technology in third and advanced patient/participant matching in fourth. Faster source document collection, automating regulatory tasks and, startup and trial master file completion all tied for fifth, while site selection was eighth on their list of priorities.
The Florence survey found that 43 percent of responding sites have to log into and use five or more different applications for every one of their trials. Caruso noted that in many cases, they’re never used again.
The technology often used in decentralized trials (DCT) can add to site burden. “In many cases, decentralized trials dramatically complicate and even centralize some of the execution activities that have to go on,” Ed Seguine, CEO of Clinical Ink, a trial technology company, said.
“Now we’re in the settling out phase of what’s going on, from a mentality of ‘anything goes’ to ‘how do we actually do this and do this consistently?’” he said.
Another area where sites and sponsors are not always aligned is training. Amanda Steenbergen, senior director of global clinical training at WCG Trifecta, noted how critical it is for sponsors to give sites training content that is concise and clear about the most difficult elements of the protocol. It helps to conserve precious time and resources that can be wasted by repetitive, bulky training plans.
“Don’t let the most important points that you want your sites to remember get lost in the training content because those points are surrounded by things that are common sense,” she said. “Skip the self-explanatory points and focus on the hard and more challenging parts of the protocol that you identified as risks.”
Steenbergen said sites are forced to go through training content designed as if sponsors forgot about the experiences and qualifications sites listed in the feasibility questionnaires that convinced sponsors to select them.
Timing of training is also critical; it’s common sense that site staff who are trained weeks or months before enrolling the first participant could forget some of the things they’ve been taught about the trial. In addition to ensuring that everyone receives the same level of training at a site, sponsors should provide it just in time, she said.
For training delivered at a site initiation visit or web meeting, record that content and put it online so that sites and clinical research associates can access it on demand and throughout the trial, she said.