Clinical Trials Research Alliance
By the numbers
350: Growth in percentage points of sponsor funding in 2014 compared to 2013.
160: Number of patients currently enrolled in CTRA-managed studies. Number is projected to double over the next six months.
150: Number of physicians with whom CTRA works.
22: Clinical trials to date.
10: Number of additional trials for which the CTRA is finalizing contracts and which may be under way within the new few months.
3: The CTRA uses three commercial institutional review boards along with Wright State University’s own review board for clinical trials. Such boards are independent committees meant to approve, monitor and review biomedical and behavioral research involving people.
Sources: CTRA and CenterWatch.com.
Clinical Trials Research Alliance partners
Wright State University Boonshoft School of Medicine: The school is affiliated with seven teaching hospitals in the greater Dayton area and has formal affiliation agreements with more than 25 other health-care institutions locally.
Wright State Research Institute: WSU scientists and researchers working with government and business.
Premier Health: Working in more than 100 locations in Southwestern Ohio, Premier Health, with more than 14,000 employees and 2,300 physicians, is the region's largest hospital group and group of specialty care practices.
Source: CTRA
When it comes to medicines and medical treatments that change lives, clinical trials are meant to be trailblazers.
In Dayton, an alliance of three organizations — Premier Health, the area’s largest hospital system, and the Wright State University Boonshoft School of Medicine, the immediate area’s sole medical school and Wright State’s Research Institute — is quietly blazing that trail, alliance leaders say.
The alliance is giving patients, physicians and industry new options in exploring what works — and what doesn’t.
Dubbed the Clinical Trials Research Alliance (CTRA), the organization for nearly three years has organized trials that help physicians find new ways to treat patients dealing with chronic diseases like cystic fibrosis and Alzheimer’s, as well as diabetes, asthma and stroke and much more.
For people like Bill Elder, a third-year medical student at Boonshoft who has suffered from cystic fibrosis since childhood, trials make a difference.
With the new medicine Elder has been taking, he said he can breathe easier and sleep better. He’s even running again.
“For me at least, it’s dramatically improved my life,” said Elder, whose condition can increase mucus production to the point where breathing is impaired.
Today, some 160 local patients are enrolled in CTRA-monitored trials. That number is small, but the alliance is growing through acquisition of new trials sought by the health-care industry, including pharmaceutical companies. Through November 2014, the CTRA has seen a 350 percent increase in sponsor funding compared to calendar year 2013, according to Mark Wysong, the alliance’s director of operations. (Alliance leaders declined to give exact figures, calling them proprietary.)
Dayton is almost perfect as a home for clinical trials, said Dr. Arthur Pickoff, alliance director.
“The advantage we have is, the community is big enough to have all the patients, but small enough for us to wrap our arms around it,” Pickoff said. “It’s a unique arrangement.”
Gov. John Kasich’s administration launched the Cleveland-based Ohio Clinical Trials Collaborative last year as a way to draw a stronger health care and pharmaceutical industry presence in the state.
But as important as economic goals are, patient care is the bottom line, said John Peterson, global business development director for the collaborative.
“If we accomplish nothing other than to improve patient care in Ohio by providing our citizenry with access to breakthrough, emerging therapeutics and medical devices for disease treatment, we’ve met the noblest goal,” Peterson said.
The research is meant to be just that. It’s not clinical care. Not every participant receives a medicine that eases a disease or a condition. Sometimes new medicines aren’t effective or won’t help all patients. Sometimes, control patients are given placebos, placeholder substances that have no effect. And participants are warned that new medicines may not work.
“We can’t really promise people that they’re going to get any benefit from a study,” said Dr. Larry Lawhorne, professor and chair of geriatrics at Boonshoft. “Whether it’s a placebo or not, you can’t make that promise.”
Patients must be carefully selected for trials, and the trials themselves must pass muster with a local institutional review board, a board of experts weighing whether a proposed trial is safe.
The alliance uses three commercial institutional review boards along with Wright State’s own board for clinical trials. Such boards are meant to be independent committees that weigh, approve, monitor, and review biomedical research on people.
Helping patients breathe
The idea is to find care that works. That simple idea led to Elder’s lifelong fascination with research into cystic fibrosis, a disease he has sought to understand since at least age 8, when he was first diagnosed with the ailment.
“I got very interested in research, primarily because it offered me hope,” Elder said. The idea that a group of “very smart people” were working to improve his life was an alluring one, he said.
Kalydeco is a drug that thins the mucus that can build up in the lungs of cystic fibrosis patients. It can also address the salty perspiration that some CF patients experience.
Thanks to research and trials, Kalydeco is no longer an experimental drug, said Dr. Hari Polenakovik, an infectious diseases specialist at Miami Valley Hospital.
But even after a drug is approved, trial work is not finished, Pickoff said.
“Many drugs require ongoing collection of data, collection of information,” he said. “There have been some notable examples of drugs removed from FDA approval based on post-marketing studies.”
Later phases of trials help hone in on more precise findings, Polenakovik said.
In later phases, “We can actually give that medication to patients who are very severely ill or patients who are mildly ill, and see whether that’s going to make the difference,” he said.
A big difference, sometimes. While trial participants are given no guarantees, there are “compassionate-use” protocols that allow patients whose lives are in danger to take drugs still considered experimental
“This particular drug (Kalydeco) actually saved the life of one of my CF patients,” Polenakovik said.
Elder participated in trials that led to Federal Drug Administration approval of Kalydeco in 2012. And he said he’s secure in the knowledge that his participation helped establish the drug’s effectiveness, at least for some patients.
Academic-community partnership
When the trials alliance was formed in February 2012, leaders at WSU and Premier promised a “major investment” of $4 million over five years to support the partnership. The partnership was expected to build a $5 million to $7 million annual research portfolio over five years, roughly doubling what the medical school and Premier had at that time.
Much of the work the alliance handles is administrative.
“We’re handling kind of the infrastructure piece,” Wysong said. “We’re taking a lot of that out of the hospital, taking that out of the university research-sponsored programs office. It speeds up our ability to get things out the door, contracts and budgets and things like that.”
But the alliance is also a unifying force, leaders said.
“Rather than isolated pockets of clinical research, this is a coordinated partnership,” Pickoff said.
Wysong declined to say how much had been raised in research funding, but he said the alliance has been ahead of its annual goal each year.
“We’re on target in terms of financial performance and trial acquisition,” Pickoff said.
The number of participating patients is expected to grow, too.
“Many outpatient health care providers see several patients every day who may qualify for a high blood pressure drug study, high cholesterol study,” Wysong said.
Research home
Wright State Research Institute, based off Col. Glenn Highway near WSU’s Fairborn campus, can be seen as the “home” for the clinical trials, which themselves happen in doctor’s offices and hospitals all over the area. Health care itself is an increasingly important part of the university’s research work, said Dennis Andersh, chief operating officer at Wright State’s Applied Research Corp.
“That’s a very big part of our portfolio,” Andersh said in an address at Wright State in August. “In fact, if you look at the (Wright State) Research Institute’s portfolio, about a third of it is defense, a third of it is health care and the other third is working to help grow the Dayton region.”
In one sense, health research is undeniably expensive. According to a New England Journal of Medicine study released in January 2014, research anchored in the United States amounted to $131 billion in 2007, just over half of global medical research spending that year.
While alliance leaders could not say how many trials happened in the Dayton area before CTRA’s formation, they believe the organization will “dramatically increase” the number of clinical trials happening in Dayton.
Prior to the alliance, it was more difficult for Dayton physicians to find the right trial, develop a budget and get the trial approved by an institutional review board for the trial, Pickoff said. WSU has its own institutional review board to consider proposed trials. But there are commercial review boards, as well.
The alliance has had about 22 trials to date, Wysong said. And it has a pipeline of about 30 trials upcoming, as well.
Loren Friedman, director of the alliance’s clinic trials, says they alliance is are examining medicine and lifestyle-body weight program for diabetics. Dr. Edward Thomas, an Oakwood ophthalmologist, is preparing to participate in a trial on diabetic blindness and sight ailments for patients dealing with diabetes.
Current CTRA studies include two obstetrics/gynecology studies as well as a series of stroke studies. A series of cardiovascular studies are happening, and CTRA is also examining the effectiveness of robotic surgery.
The alliance is also weighing multi-site trials with Dayton Veterans Affairs Medical Center, exploring post-traumatic stress disorder, Wysong said.
“It’s pretty classic,” Friedman said of typical health problems for Dayton-area residents. “It’s things like diabetes, it’s things like weight. We’re not exercising well, (residents have) cardiovascular issues, stroke. The whole gambit.”
“It pretty much runs along the national guidelines. It’s probably a little bit higher,” he added.
Pickoff predicts more studies in the future. He sees more trials being launched by physicians or investigators, rather than coming from industry or the Ohio Clinical Trials Collaborative.
One alliance goal is to recruit the right kind of investigators to Dayton.
Said Pickoff, “We actually have this vision that Dayton, Ohio, becomes the center for clinical trials in Ohio.”
New tools to fight diabetes
Oakwood ophthalmologist Thomas, 78, has continued his father’s eye practice, which dates back to the mid-1930s. He is involved in the treatment of what he calls “diabetes of the eye.”
“We certainly see there’s a need for patients to become aware that diabetes can cause blindness, diabetes can cause what we call ‘preventable blindness,’” Thomas said.
Diabetes is an insidious disease that, if left untreated, can lead to loss of limbs and kidney damage. And often, diabetic macular degeneration can be traced in a patient’s eyes.
Thomas’s office has a new instrument called a “Heidelberg Eye Explorer.” The instrument, basically a sophisticated camera, allows Thomas to minutely track what’s going on within the eye — damage and degeneration.
“In the eye,” Thomas said, “we can see exactly what’s going on.”
The CTRA is working with Thomas to add a research element to his practice, Friedman said.
“So the patients as they come in can get not only their regular standard of care but other options are available to them: Investigation of medications, new techniques in eye surgery, different things that normally wouldn’t be available to them,” Friedman said.
Julie Lillie is a senior clinical research associate with Quintiles Inc., which calls itself the world’s largest provider of bio-pharmaceutical development. She has worked with Miami Valley Hospital researchers since before the alliance was formed, and she praised their professionalism.
“They’re wonderful to work with,” she said. “They’re a caring people.”
Based in Durham, N.C., Quintiles’ mission is to develop drugs and medical devices and to manage clinical trials.
The development of new treatments and drugs would not be possible without clinical trials and without industry-research partnerships.
“Our work impacts millions of people,” Lillie said.
CTRA staff today is lean, a “handful” of staff employees, Pickoff said. But in addition to physicians, there are another 20-plus nurses and others supporting trial work now, organizers said.
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