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Being the lead on a large multisite grant involves big dollars. It also requires more work, collaboration and accountability. That’s a good thing, say researchers.
For decades, RO1 grants from the National Institutes of Health (NIH) have been the gold standard for scientific research. The awards allow a single researcher to work largely unfettered for periods of up to five years. They require little substantive reporting until the end of the funding period. And if the scientist comes through with results – or makes significant progress – she might be rewarded with additional funding.
Now, a growing trend in NIH funding is the “U” series of awards. These are cooperative agreements, rather than grants.
“Cooperative agreements are a support mechanism used when there will be substantial federal scientific or programmatic involvement,” says Pete Koch, assistant vice president for Sponsored Programs at Cincinnati Children’s. “This type of support mechanism is increasingly common in large-dollar awards such as clinically-based research projects.”
These projects are often multisite studies, requiring an enormous amount of work and coordination by the lead center. They demand close cooperation among researchers at the lead site and investigators at participating sites, regular progress reports and strict oversight by the NIH.
Despite the additional demands, the awards are highly sought after.
“Directing a multicenter trial is like being the leader of the pack. It establishes the study team as the research leader in improving children’s health,” says Tracy Glauser, MD. “As the lead institution, we can help coordinate and organize the pediatric community to answer some fundamental questions.”
Glauser is a neurologist, researcher and associate director of Clinical, Translational, Outcomes and Health Services for the Cincinnati Children’s Research Foundation. He also is the lead investigator for a U award to compare epilepsy treatments.
At a time when federal funding is more competitive than ever, Glauser says U awards strike a balance between responsible science and fiscal accountability.
“The NIH wants to be a good steward of taxpayer dollars. With U awards, they partner with us to run these large multicenter studies,” he says. “They attend the meetings and are on the conference calls. They can call in every week to hear about day-to-day operations. The people at the government can know exactly what’s going on at all times.”
Although this level of oversight might raise hackles among research purists, Glauser sees it otherwise. Most U awards require research to be conducted at multiple sites, boosting the validity of the findings. It is easier to recruit greater numbers of patients to the studies, especially when studying rare diseases. So researchers can generate results more quickly.
U awards cover a range of medical research areas, from interventional clinical trials to observational studies. Other types of NIH awards also encourage multicenter collaboration, but none to the extent of a U award. Cincinnati Children’s multisite trials include studies in asthma, migraine headaches, epilepsy and improving compliance with medication taking.
All multisite awards pose significant challenges for the lead institution. For starters, the coordinating site must line up all the other sites for the study. Then begins the massive task of creating the infrastructure needed to support those sites.
“Multisite studies take it to the next level from an administrative perspective,” says Koch. “As the lead institution, we’re responsible for everything that happens at all of the sites. There are many contractual, liability and regulatory issues that have to get worked out.”
A study such as our recently awarded migraine medication project will involve as many as 40 clinical sites. That means Koch’s office will have to negotiate contracts and agreements with 40 sites, each with varying levels of capabilities and requirements.
Additionally, he says, Sponsored Programs staff will develop consistent procedures for tracking, reporting, and fiscal management of the award. They must ensure that the protocols for each site are approved by their IRBs; manage frequent fiscal reporting to NIH; rebudget more restrictively; and accept greater NIH involvement overall.
This added complexity requires that the lead institution have capabilities beyond science and medicine, says Koch.
“Clearly the funding comes to where the researchers are. It starts with the principal investigators and their capacity. But not having the right environment or infrastructure absolutely can impact the likelihood of funding. If the NIH didn’t think we could administer this, we would not have gotten it.”
Still, even the best-resourced institutions grapple with the demands of a multisite study – or, in our case, running multiple multisite studies at once. It does not happen overnight. For several of our recently acquired U awards, it will take months to put the pieces in place before the clinical trials can begin. Glauser says part of our research strategic plan is to develop and maintain an infrastructure that can power up quickly to meet the demand when a new multicenter study is funded.
“When these awards go through, you want to be ready. We are working on bioinformatics, data management, biostatistics, epidemiology and clinical study design, clinical pharmacology. Our goal is to expand and further enhance our capabilities in those areas so researchers don’t get slowed down,” he says.
And there is the pressure to meet study goals.
“The NIH puts milestones on us,” Glauser says. “If we hit their milestones, we get our money. So for an $11 million grant such as our epilepsy study, they might commit $6 million up front and if the study is going well, then you can get the rest. If it is going poorly and can’t be fixed despite multiple attempts, then they can say, ‘I’m sorry, you’ve wasted $6 million but at least we haven’t wasted $11 million. We don’t want to waste any more money on it.’”
With all the challenges, why do institutions pursue these grants?
“Large multicenter grants are an important key to improving children’s health,” Glauser says. “Pediatrics is a collection of uncommon diseases. It’s not like breast cancer or heart disease, where you can have one disease with thousands of researchers working on it. In pediatrics, we’ve had uncommon diseases that one person works on. These larger multicenter trials focus on uncommon diseases where we have to work together to solve the medical challenges.”
Tracy Glauser, MD.
Tracy Glauser, MD, says leaders in multicenter studies have to have outstanding talent, infrastructure, collaborative culture and space.
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