Super Focus Leads To Super Clinical Research Sites, Execs Say

May 29, 2018

The characteristics of the most successful sites are focus on their core competencies and an understanding of their own limits, a panel of executives agreed Tuesday at the MAGI Clinical Research Conference 2018 East in Arlington, VA.

Tonya Ward-Kiser, senior director of operations at PMG Research Inc. said her company had been able to focus better and to improve its performance by hiring an outside consultant to put together data-driven feasibility studies. Ten years’ worth of data helped PMG predict how well it’s going to do on trials and helps the company answer two key questions.

“Does it make sense for us, from a revenue standpoint, to take the trial — are we going to be able to enroll it? Number two, what can we tell a sponsor in terms of are we going to meet the trial goals and what level of confidence can we provide for them?” she said.

Through the feasibility data, PMG learned that its strongest trials were in urology (94 percent enrollment), pulmonology (100 percent) and cardiovascular health (120 percent), Ward-Kiser said. The data has helped PMG understand where it needs to improve its performance, she said.

Nelson Rutrick, CEO of Adams Clinical said his company tries to learn its own limits from one-off mistakes. After a disastrous trial involving ADHD in adolescents — where Adams Clinical struggled to enroll enough older teens for the sponsor — the company swore off ADHD trials, Rutrick said.

“You can get better at things but sometimes you should give up,” Rutrick said, to laughter.

Companies can also learn where to focus by mandating buy-in from employees at every level, said Christine Senn, chief operations officer at IACT Health. When IACT Health saw that a lot of its strategic or even tactical planning wasn’t “cascading down” to its employees, the company formed what it called “Level 10” meetings where every employee is expected to join in, with weekly goals for their subject areas. It’s in those meetings, Senn said, where the company finds out “Where did the pulmonology trials go?” she said.

In focusing on core competencies, the best sites also focus on core partnerships, Senn added. “You don’t get offered a better budget just because you’re a terrific site. We’ve become preferred partners with CROs. Not that they give us better budgets, but they know our quality, and you start building that relationship,” she said.

It’s worth the time, as well, as the relationship develops, to go through a sponsors’ database to make sure the information they have on your company is accurate, Senn said. A site’s project manager becomes a kind of liaison to a CRO “and [can] really have that communication,” she said.

Changing gears toward enrollment, Rutrick said one of his “secrets” was learning that sometimes sponsors say a study is closing when they really mean enrollment is closing.

“What I’ve done, historically, when I find out a screening is closing,” he said, “I’ll frequently have a bunch of participants that were scheduled to come in the next few weeks or participants that maybe had come in previously and had marijuana in their system or something that would exclude them from a trial and we’ll say, ‘Oh come back in a month, we’ll see if you can stop smoking.’ And I’ll have every one of them come inside and I’ll have a much higher screen-failure rate for that group, but because they all signed a consent, they all count as participants and they’re still allowed to be in.

“Even if the sponsor says, ‘The enrollment’s over today at midnight,’ I’ve stayed at my site for 10 more hours and called up every person and said, ‘If you get in right now, all you have to do is sign a consent form and we’ll finish the screening another day,’ “ Rutrick said.

Sponsors have come to expect these last-minute surges, Rutrick said, “and it has turned into maybe 5 to 10 percent more revenue.”

-William Myers