By SUSAN JONES
Pitt has long been a leader in medical research funded by the federal government, now a new Clinical Trials Office will help set up the infrastructure for the six schools of the Health Sciences to get more involved in studies funded by big pharmaceutical companies.
“We need to diversify, because we are heavily focused on federal grants, and the federal grants, there’s a limit to how much we can grow that,” said Anantha Shekhar, senior vice chancellor for health sciences. “But there’s an equal amount of research funding from corporate sources that we haven’t taken advantage of. Many other peer institutions who are top academic medical centers do five to 10 times more clinical research than we do, and that’s what we need to catch up on.”
Shekhar said of the nearly $800 million in grants Pitt Health Sciences got in 2023, only $40 million of that was for clinical trials. “You can see how little we do in the first place, which is the first thing we want to change,” he said. ”We should be doing $200 million or $300 million worth of clinical trials not $40 million, considering how big of a medical center we are.”
In the past, clinical trial were not a priority at Pitt, Shekhar said, so the right infrastructure, relationships and processes were never developed.
Mark Geraci, associate vice chancellor for interdisciplinary research, Health Sciences, said he worked with Shekhar at Indiana University to create a statewide clinical trial infrastructure, which became very important to the state of Indiana.
“I think what he wanted to make sure of is that here, with a much bigger research and healthcare organization, we make sure that we’re able to deliver the best care to patients,” Geraci said. “And oftentimes the best care for patients might be new or experimental, and often the investigators that we have here are leading the charge to develop these new therapies. So can we create a platform that makes their ability to bring care to the patient much easier.”
Pitt also has been working at the federal government’s pace, which can take a year from applying for a grant to when a funding decision is made, Shekhar said.
“Industry is very different. For them, every day is money,” he said. “So they avoid going to academic medical centers like Pitt, because we are slow and we don’t have the right infrastructure. If we build these fast turnaround offices where you can approve a contract within three to four weeks, as opposed to six to nine months, then they will be more interested in coming and working with us. And that’s the reason why we are creating this office to make it more efficient, faster and easy, quick turnaround, so we can move at industry pace, as opposed to the federal government pace.”
Shekhar said it will take two or three years to get the clinical trials operation at Pitt up to full speed, but he expects that in the next three years “we will double or triple the volume of studies we’re doing today.”
A big part of this also will be community engagement and getting the community excited about participating in clinical research, he said.
Finding subjects for human trials is a problem at all academic research centers, Shekhar said. He pointed out that of the 100,000 or so human subject trials registered at clinicaltrials.gov, only about one-third actually have people enrolled.
The other issue is that the majority of drugs approved in the U.S. were only tested in white men. Researchers need to get more women and minorities involved in clinical trials. “This office would be focused on targeted recruitment making the process convenient, whether it’s transportation, parking or various other things that prevent people from coming to the clinics and getting engaged in clinical research,” Shekhar said.
Patricia Corby, who came to Pitt in 2023, will lead the office as the inaugural associate vice chancellor for clinical trials development and operations. She came to Pitt from the University of Pennsylvania where as associate dean of translational research at the School of Dental Medicine she spearheaded a significant expansion of clinical and translational support. She also previously led the clinical research operations and the Center for Large Scale Clinical Studies for NYU Langone Health.
Corby and her growing team have spent the past seven months building the foundation to centralize the business of clinical trials.
“Most universities, they have an office of clinical trials, which is the door for the university to help our investigators to navigate in this very complex pre-award phase and regulatory process,” she said. While researchers know much about their subjects, they often aren’t well-versed in the regulatory process to develop new drugs and other treatments.
To build a clinical trials office in an organization as large as Pitt, “you need to have a very good analysis to understand what parts you’re going to centralize and what parts you can still leave decentralized and work together with the research community,” Corby said.
They focused their work on creating a human resources component to attract talent to Pitt in this new area; building the technological infrastructure and developing best practices that will be standardized across departments. The new Clinical Trials Office will have a searchable website, which is expected to be up and running next week.
They worked closely with Duke University, which Corby said has the largest clinical research operation in the country and was among the first to use the clinical trial management system OnCore. Getting tips and best practices from Duke allowed Pitt to move ahead quickly with its office.
There also was the challenge of hiring new staff to run this operation. Corby said they sought people with more experience, particularly with OnCore, but they still had to do hours of training to deal with issues in the research community, all while the system was being developed. Currently, there are about 14 people in the new office and Corby hopes to have 30 eventually.
Geraci said they also are partnering with around 50 people at Pitt and in the area that have been doing this sort of work for many years. “We understand that there’s tremendous talent locally. We want to be able to help them, and we want to learn from them, and also have them help us in the endeavor that we know we need to do.”
Investigators will be able to contact the office and be linked with a concierge who will walk them through the process. Corby anticipates the office growing in staffing and services, including supporting large grants, multi-site trials and international studies.
All studies will go through the OnCore system, which is linked to the Sponsored Projects Office that provides funding. Before all invoicing was done by hand, but now it will all go through Sponsored Projects.
She said they’re also working with Pitt’s Office of Industry and Economic Partnerships to connect pharmaceutical companies with Pitt researchers to get more funding to help “evolve and translate their ideas into their first human studies.”
Pitt’s BioForge project is another great opportunity, Corby said. The main tenant at the Hazelwood Green site will be ElevateBio, which focuses on manufacturing drugs, but to do that the company will need to test them first.
In the end, the goal is to allow departments to do budgeting and other processes they did well before, but, “We’re going to review and approve every single budget. … So that every time that we activate a study, they follow the same standards, overhead is the same, we validate institutional policies, we check conflict of interest, and every approval that they need is in the system, … and we say, yes, now you can enroll your first patient.”
Susan Jones is editor of the University Times. Reach her at suejones@pitt.edu or 724-244-4042.
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