The pros and cons of cooperative research
Oncology group director shares experiences
Research sites that struggle with bureaucratic details in clinical trial research might benefit from cooperative research group agreements in which a larger site shoulders more of the administrative burden, an expert suggests.
"We get a number of calls from sites that are frustrated with the burden and complexity of traditional pharmaceutical studies and are looking for some alternative, and we’re working hard to provide that for sites," says Jake N. Vinson, MHA, CCRP, executive director of Hoosier Oncology Group in Indianapolis.
Hoosier Oncology Group, which has about 20 years of experience as a nonprofit medical research organization, provides services to clinical scientists to help them facilitate their concepts from hypothesis to research journal publication, Vinson says.
"We work with sites in cooperative partnerships that participate in research efforts and have access to studies we develop along with clinical investigators," Vinson explains. "We currently have 30 or better institutional participants from Nebraska to New Jersey, and those institutional participants are private practices and group practices and sites as large as having 10 oncologists working together."
The idea is to facilitate clinical trials in the community setting, Vinson says. "We have historically been conducting studies of marketed compounds and are transitioning to working on investigational new drugs," Vinson says. "If we can get new, exciting and promising compounds into our trials, then our researchers are very interested in doing that and our sites are very interested in doing that."
Hoosier Oncology Group primarily works with phase II studies, but also does some phase I escalation studies, he says.
"Our intent is for the majority of patients to come from the community setting," Vinson says. "We bring principal investigators from the sites together and go over what we have and what’s in development and the gaps in research."
Cooperative research groups enable patients to stay close to home and still participate in cutting-edge research, Vinson says.
"Our success story is that we’ve seen our number of sites interested in participating elevating, and the number of patients going on the study increasing," Vinson says. "The number of investigators interested in having studies developed also is increasing."
These meetings of community investigators and academic investigators lead to better ways of conducting clinical trials, Vinson notes.
Community investigators are a good reality check for the lofty ideas of academic researchers, he says.
"Community investigators say, We’d like to get a 12-hour pharmacokinetic sample, but 12 hours later our offices are closed,’" Vinson says.
"There’s been a long-standing tug of war between community and academic clinicians, and for us to bridge that gap is something I’m proud of," Vinson says. "We’ve made this a bedrock of our organization—we’re inclusive, not exclusive."
Each site has to complete a regulatory package that includes principal investigator training, staff training, human protection programs, and work with investigators and their sites to address their needs, Vinson says.
"One of the things we take pride in is when you call here someone always answers the phone, and your call will be handled promptly," Vinson says. "We don’t have the answers at our fingertips, but we can get those answered and have customer service sent to the sites."
Vinson outlines some of the challenges and advantages of cooperative research groups:
• Mixing different interests: "Some of the difficulties come in the way of working in a line of investigators," Vinson says. "It’s very difficult as you mix academic centers."
When a cooperative research center begins to expand the amount of science in a process there may be academicians from the various institutions who do not agree with the decisions that are made, Vinson says.
"So sometimes it’s difficult to come to consensus on what is the best study and concept to do," Vinson says.
A cooperative research group’s challenge is to incorporate the latest regulatory guidance and issues that have implications for the clinical sites that are participating with the study and still obtain those sites’ buy-in, Vinson says.
"It’s easy for us to say we offer good studies, but if those sites aren’t invested in what we’re doing and they’re not invested in contributing to the clinical process they won’t put patients in the study," Vinson says. "Physician leadership is terribly important for our organization, and it takes a dynamic leader to be able to scientifically have a sense of what best concepts will be and be able to relate to the community environment."
• Cooperative research center is resource tool: "We don’t promote the center as conducting research on behalf of the university," Vinson says. "The majority of science does come from academic centers, but we position the center as a resource or tool to be used by academic centers or community groups."
From the perspective of academic centers, the involvement of community groups enables research to be done more quickly, Vinson notes.
"And the community guys don’t want to sit down and write a whole protocol," he says. "They will have an incentive to accrue to those studies and fulfill their wishes to do research and do it in a collaborative way."
Also, Hoosier Oncology Group provides services to sponsor investigators from the moment an idea is conceived, Vinson says.
"We help them navigate the research process all the way through until they’re presenting data at a nationally recognized meeting," Vinson explains. "We go through a series of steps, research feasibility and study planning to be sure it is a concept we could be successful in doing, and then we identify collaborators."
For instance, Hoosier Oncology Group will work with biostatistics professionals to put together an appropriate sample size, he says.
"We shop the concept around, and we usually have a pretty good idea that someone would be interested in what we have put together," Vinson says.
• Carrying the process from concept to publication: When a research concept is aligned with a pharmaceutical company’s internal business plan, the cooperative research center will put together a letter of intent in which the concept is described scientifically and logistically, Vinson says.
The letter of intent will include details about how many patients will be enrolled and how much money the study will cost, he says.
"Ideally, the pharmaceutical company will agree it’s something of interest to them and move forward on this research idea," Vinson says. "So from there we develop a protocol."
The investigator drives the protocol, but the cooperative research group assists with writing it, as well as with designing the data collection and management and the data analysis plan, Vinson says.
All data are collected electronically in clinical trials, and then data are monitored and managed by the cooperative research group, Vinson explains.
"We work to clean it and make it in a condition so it could be analyzed by our statistician again," Vinson says. "When all patients are accrued by sites, the protocol is done, the data system is ready, then the protocol is distributed to sites, and we set up meetings with each of them."
The next step is to manage the regulatory aspects of IRB submissions, subject enrollment, drug orders, and day-to-day research management issues, Vinson says.
"We enter the data in an electronic data system on the Web, and we go through the data and then, ultimately, have statisticians get together for presentation," Vinson says.
Each site has its own research infrastructure, but the Hoosier Oncology Group supports them, he says.
"Once a site has been qualified, meaning they’ve gone through the different requirements for regulatory compliance, training, and the contract, etc., then they have access to the research portfolio and can pick and choose from 15 to 25 open studies," Vinson explains. "So we don’t have to re-qualify a site for every trial."
More clinical trial sites should consider forming cooperative research groups because of the advantages these offer in improving clinical trial research, Vinson notes.
"We have to offer more targeted services to our sites to meet their needs so research isn’t a burden, but rather something people can enjoy at the end of the study when they’re proud of what they’ve accomplished," Vinson says.
Research sites that struggle with bureaucratic details in clinical trial research might benefit from cooperative research group agreements in which a larger site shoulders more of the administrative burden, an expert suggests.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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