One research institution has hit on a formula to upgrade its business operations that has helped open it to more trial opportunities and made it more competitive, particularly in COVID-19-related trials.

Franciscan Health, a community-based network of hospitals in Illinois and Indiana, developed a formula that made improvements in four areas: setting firm fees and detailed costs, improving timing of administrative tasks, more effective contract negotiations and getting trial enrollment started on time.

Sites need to stand their ground when negotiating fees, says Kathleen Kioussopoulos, Franciscan’s director of research administration. Sponsors will often push back against a standard fee schedule, but if sites have a good understanding of the fair market value for their services and can provide a rationale or documentation on the pricing, Kioussopoulos said, sponsors relent about 80 percent of the time. “You also don’t want to undersell yourself,” she told attendees of a WCG webinar last week. “It’s important to get your costs covered and be sure that you’re adequately budgeted. You will get pushback, but that’s okay.”

One particular pain point for sites is the concept of sponsor-imposed budget holdbacks — money placed into reserve and not allocated. “Sometimes they want to hold back 10 percent or 15 percent, Kioussopoulos said. “It’s a negotiation, but I do try to push to get that either removed or reduced.”

The network, which is a member of the Alliance for Clinical Trials in Oncology, tackled the problem of administrative overload, she said, with the help of trial support organization WCG PFS Clinical. By establishing a standardized approach toward study initiation and workflows and running studies “in parallel to whatever degree possible,” Franciscan was able to coordinate administrative tasks and offload them to the vendor, Kioussopoulos said. “We don’t carry the staff to negotiate budgets and to do coverage analysis, for example. But if we suddenly have 15 studies we need to look at, we can send them off and get those done.”

Franciscan also updated its clinical trial agreement (CTA) terms to respond to recent trends in the industry, such as the proliferation of personal privacy laws in Europe and elsewhere. “We’re being asked to have foreign laws be a part of our contract,” she said. “It’s hard to imagine why we would agree to that.”

While injury and indemnification clauses are still important, she said, sites also need to ensure their CTAs allow them to potentially terminate a trial if necessary; many CTAs “are very one-sided,” she said.

With regard to study enrollment, Kioussopoulos said sites need to do their homework by “looking at your patient population, the disease process, statistics, analytic cases and understanding exactly what you treat and how you treat it.” She said Franciscan has recently partnered with a startup company that uses natural language processing and artificial intelligence to look at oncology trial patients’ molecular markers to see if they have an adequate patient population. “It’s really been helpful for us to know whether we really have patients with that mutation instead of just thinking we do,” she said.

Kioussopoulos said physicians, their patients and patient advocacy groups should all be made aware of the details for when a clinical trial is starting in order to boost time to first enrollment. “Make sure that your physicians are aware of the trial getting close to opening,” she said. “If you don’t have that date or know exactly when that trial is going to be open or if it gets delayed, that’s where people lose the enthusiasm.”

And poor enrollment numbers can turn sponsors away, according to Sandra Smith, senior vice president for clinical solutions and strategic partnerships at WCG. While there are “plenty of solutions being touted on the marketplace as to helping with enrollment,” Smith said, she warned that if sites have poor enrollment with a sponsor “that is something that’s very difficult for them to forget. When you’re doing your feasibility study, you’re going to have raving fans if you can not only meet the target but exceed it. If you’re able to get that first patient enrolled, that really is an indicator that you will be successful in your enrollment.”

“Physicians think that once you’ve signed the consent and you’ve done the enrollment that it just keeps going,” Kioussopoulos said. “But there’s a lot of work that goes along with that. You need to make sure that you can keep the cadence correct for enrollment and not say ‘I need to be in the top 10 sites. No, you need to be a good site with good, consistent data. You wind up managing that balance between enrollment and quality and being able to catch up.”