New streamlined clinical trials process being launched
By Ginger Hall Carnes
Sponsors who want to conduct clinical trials with UT Health San Antonio call a new streamlined process being launched by the vice president for research efficient and effective.
The streamlined system is still in its infancy, but sponsors, as well as UT Health San Antonio researchers, praise the Clinical Trials Office (CTO), led by Jason Bates, whose staff praised the coordination afforded by the single point of contact services provided by the CTO..
In the past, sponsors such as pharmaceutical companies would search the campus for a principal investigator to work on a study, then they would spend months negotiating budgets and contracts before they could launch a study. Many times they were submitting the same information to different offices multiple times in different forms.
Similar to the efficiencies recognized when leveraging the VPR Clinical Trials Office, the University of Texas System, together with the Texas Regional CTSA Consortium (TRCC), a System-wide consortium of NIH-funded Clinical and Translational Science Award (CTSA) programs, envisioned a scalable operating model and centralized infrastructure with streamlined efficiencies to accelerate timelines associated with multi-site clinical trials. Hence, in 2015, Clinical Trials Xpress (CTX) was launched to offer industry and physician investigators a single point of access and dedicated, experienced team to facilitate opening of trials using master clinical trial agreements, a common study budget and single IRB submissions. The CTX Network is comprised of the five UT health science centers and their affiliates: UT Health San Antonio, UT Medical Branch in Galveston, UT Southwestern Medical Center in Dallas, UTHealth in Houston and MD Anderson Cancer Center. Collaborative Clinical Research Solutions, (CCRS Consultants), manages the day-to-day operations of the network.
Patty Winger, president of Collaborative Clinical Research Solutions, Inc. (CCRS), explained that the traditional model to implement multi-site clinical trials is very time and resource intense for companies like PAREXEL, adding that “CTX and the Network institutions simplify the process and lowers the hurdles for investigators and industry.”
Gwen Welty, associate director of site alliances for PAREXEL, an international corporation that conducts clinical trials for biopharmaceutical and medical device clients to expedite the drug approval process, said CTX would be a “game changer with a university system as large as the UT System. Their goal is to be able to start a study within 100 days. If that comes to fruition, there’s not going to be a university or hospital in the United States that’s going to be able to compete with that.”
PAREXEL’s Welty, whose company is the second largest clinical research organization in the world with 80 locations in 50 countries, said it will be “completely amazing” because it will bring so many opportunities to patients in the state of Texas that are associated with the hospital and university systems.
Why does UT Health San Antonio want to increase the number of clinical trials? “They offer alternative treatments for the patients we serve,” said Joseph Schmelz, Ph.D., assistant vice president for research administration. “They represent new, innovative ways of treating, preventing and diagnosing diseases that give our patients options that they would not have if we didn’t have clinical trials open.” In addition, they offer students and researchers the opportunities to learn from cutting edge research.
Clinical trials also boost the economy. “Texas ranks No. 3 in the nation for the number of clinical trials with approximately 20,400,” said Tom Kowalski, president and CEO of the Texas Healthcare and Bioscience Institute. “It is important to have a system which provides patients access and treatments as the state is a large state geographically and access is critical. Texas is among the top tier of states in the size of its bioscience and biomedical research and innovation base with a contribution of $52 billion to the state’s economy.”
Two buckets that the new system focuses on are the business side, which involves the important budget process and the Institutional Review Board (IRB) side, which protects the participants in the studies.
“We used to negotiate individual IRB agreements with every site we were doing multi-site research with and individual contracts with commercial IRBs,” explained Kimberly K. Summers, PharmD, director of research protection programs in the Office of Clinical Research, and the Office of the IRB. The IRB office she oversees has implemented the SMART IRB Authorization Agreement, a national model that allows one agreement and expedites the turnaround timeline to get studies going.
The new system puts the budgeting process ahead of the IRB review process. “We expect it to be a complete culture shock because it’s moving more toward what a commercial research site would be doing in terms of negotiating the contract and budget first,” said Bates. When a sponsor reaches out to Bates’ office, his staff alerts the UT Health San Antonio campus and the VA Hospital to see if there is interest among the researchers. Getting an answer used to take weeks but now takes only a few days.
The Office of Sponsored Programs, led by Chris G. Green, CPA, collaborates with Bates’ Clinical Trials Office to create the necessary contracts after the budget has been approved.
Because many of the studies’ investigators at UT Health are physicians caring for patients, the new system will offload the administrative burden, such as pricing study costs. At that point, the sponsors are vetting UT Health. Dr. Schmelz compared it to speed dating. “They’re looking to see whether we have the expertise, the resources and the patient population to warrant us being a good site and meeting their enrollment needs,” he said. “We tell them what we’re capable of doing, and they tell us what they’re willing to reimburse us for.”
Budgeting has lots of variables, according to Pamela Kittrell, MSN, RN, a UT Health San Antonio clinical research nurse. It involves such items as factoring the hours each task takes, how to get compensated, determining what a research unit will charge you, and the time required to respond to queries from the sponsor. It includes details such as the level of staff expertise needed to perform each study procedure. “I turned over the sponsor budget, the protocol and where we were doing it. I appreciated how Jason and his group did all the negotiating on their end. They plugged in their information and sent it to the sponsor. I still had some say in the budget, and they thought of things that I hadn’t thought of,” Kittrell said.
Robert A. De Lorenzo, M.D., professor of emergency medicine, is thrilled that the Clinical Trials Office is creating a turnkey operation. “Why should every investigator have to learn the intricacies of the infrastructure?” he asked.
De Lorenzo joined UT Health San Antonio in 2014 and had experience with other research organizations. He was frustrated with the “classic bureaucracy. I give Jason a lot of credit for trying to negotiate the budgets.” He considers the new system the “easy button,” adding, “I think that’s wonderful.”
When the institution has been “qualified” by the sponsor, Dr. Summers’ IRB staff that specializes in protecting the human subjects and the ethics of the study takes that regulatory burden off the investigators’ shoulders.
De Lorenzo said he has no complaints about the IRB, a member of the Association for the Accreditation of Human Research Programs, the gold standard for quality research programs, with an added commendation for the Research Concierge Service. “Once a month they set up a table in an accessible place,” Lorenzo said. All aspects of the human research program are represented, allowing study teams to communicate with all the relevant offices.
The IRB process is also facilitated by CTX for multi-site studies conducted at UT institutions. “The dedicated and experienced CTX staff facilitates all IRB submissions for the life of the studies on behalf of participating sites using the Texas IRB Reciprocity Agreement or commercial IRBs” said Winger, removing the burden from Dr. Summers’ team so that they can concentrate on trials that do not involve all UT campuses.
Winger states that CTX aspires to expand its network to other institutions. “The intent has always been for us to build a framework that could be utilized by other UT and non-UT institutions. Equipped with solid knowledge of institutional processes and established experience testing CTX’s operating mechanics with initial trials, CTX’s focus has now transitioned to further scale the scope of its Network, grow its portfolio of clinical trials, and expand its unique offering to a wider network of physician investigators and industry partners” Winger said.
Interested industry sponsors and principal investigators may initiate requests by calling the Clinical Trials Office at 210-567-8266 or by visiting. http://www.uthscsa.edu/research/clinical-trials/inquiries.