New Consortium Promotes Efficiency in Working Toward Clinical Trials

A new California consortium — the Partnership to Accelerate Clinical Trials, or PACT — hopes to break down the many barriers that academic research institutions face in their quest to develop clinical trials for new drugs.

The new collaborative is the brainchild of Clay Johnston, former associate vice chancellor for research at the Clinical and Translational Science Institute at UC-San Francisco. Johnston is now dean of the Dell Medical School at the University of Texas-Austin.

PACT is comprised of 11 California health systems and medical research institutions, including five UC campuses, Stanford University, Children’s Hospital Oakland, Dignity Health and Sutter Health.

Through conversations with leaders in the biopharmaceutical industry and with venture capitalists, Johnston gained insight into the struggles they were facing in developing new products. “We concluded that if we didn’t speed up clinical development, the drug pipeline would slow down,” Johnston said.

The concept  for a statewide institutional review board emerged a year and a half ago, along with the kernel of an idea for building a consortium to quicken the pace of prolonged trial reviews and ensure value, Johnston said.

“We anticipate[d] that PACT would provide high-quality review and reduce start-up time, streamline contracting, change the way we negotiate reimbursement and make it easier to determine what is covered by Medicare,” he said.

A 2010 working agreement among five UC medical campuses — UC Biomedical Research Acceleration, Integration and Development — created a foundation for PACT. It identifies policy changes and areas for collaboration to accelerate biomedical research across the UC system.

The UC campuses are able to leverage a common institutional review board and provide a single door of entry for sponsors.

PACT currently operates as a program under the umbrella of Public Health Foundation Enterprises, a not-for-profit fiscal sponsor. PACT will become a separate entity when the new consortium receives a 501(c)3 designation, officials said. Through UC-San Francisco, Onyx Pharmaceuticals headquartered in San Francisco granted PACT more than $180,000 a year ago.

PACT is aligned with the efforts of the National Center for Advancing Translational Sciences, part of NIH, which relies on data and technology to transform science into clinical applications.

Creating a Centralized Institutional Review Board

At the top of PACT’s agenda is creating a centralized institutional review board that is responsible for approving clinical trials before they begin. The approval process would include a review of participant inclusion and exclusion, adequacy of informed consent documents and where the trials will be conducted.

A single review board would assure that each trial site’s standards are met, eliminate duplicate reviews and lead to a consensus on how to proceed, according to PACT officials.

The new consortium is deciding between two commercial IRBs. PACT officials, who declined to name the two finalists, expect to make a decision by mid-July.

Michael Rowbotham, scientific director at California Pacific Medical Center Research Institute, said PACT is leaning toward a commercial IRB.  

He said new drug research requires a prolonged and cumbersome approval process and it is expensive and difficult to establish clinical trial sites in academic institutions.

“A centralized IRB is really necessary in providing an impartial response reflecting the local interests of many participants, one that understands the science and clinical aspects of trials to make them safer or to prevent them from proceeding if appropriate,” Johnston said.

“Clinical trial sponsors experience a ‘groundhog day’ effect when launching a multicenter trial,” said Gary Firestein, professor of medicine and dean and associate vice chancellor of translational medicine at the UC-San Diego School of Medicine.

 

“Confronted by different sets of rules, companies keep repeating the IRB and contracting processes,” he said. “That not only slows things down for the companies but also makes California research institutions less competitive.”

But Lars Berglund, professor of medicine and senior associate dean for research at UC-Davis, also is concerned that California may miss out on opportunities to host clinical trials. He believes PACT would make it more inviting for drug companies to work with California institutions in sponsoring multicenter trials.

Seeing Eye to Eye

“All of the UC medical schools and Stanford share a common interest in providing the best care we can and learning more about improving it,” said Harry Greenberg, senior associate dean for research at the Stanford University School of Medicine.

Earlier this year, Stanford adopted i2b2, the same information system used by UC. i2b2 is developing a scalable informatics framework enabling clinical researchers to use existing data for discovery research. Funded by NIH, i2b2 (Informatics for Integrating Biology and the Bedside) is designed to give clinical  researchers access to vast amounts of data to explore the genetic bases of complex diseases. Greenberg emphasized the importance of leveraging the expertise of all PACT participants to develop potential cures for disease by sharing data and patient populations.

For Sutter, PACT aligns with the health system’s progress toward integration. Five years ago, coordinated efforts were lacking; Rowbotham said Sutter conducted research in silos with little communication between its research organizations, including California Pacific Medical Center Research Institute and Palo Alto Medical Foundation Research Institute. 

Next Steps for PACT: Contracting, Coverage, Recruitment

After the IRB is chosen, PACT will develop a contract to be used among members and clinical trial sponsors. “Each institution speaks its own language,” Rowbotham said, “but the new contracting process will provide a master language covering how to pay patients enrolled in a trial, what injury risk provisions to include and how study costs should be covered.”

Rowbotham anticipates that a common contract will save both time and dollars, eliminating the need to negotiate from scratch.

“When you are doing a large, multisite trial, you want to have as much time as possible to look for the right patients — ones that could most benefit — and without an IRB and a contract in place, you cannot proceed,” he said.

Johnston said it will not be easy to get all parties to accept contract language but is optimistic that a consensus among institutions would be sufficient to close the deal with a sponsor.

Another issue at the forefront of PACT’s concerns is insurance coverage analysis, which the consortium will tackle by the end of the year. “Doctors could differ on what is ‘standard-of-care,’ what is billable and what is considered research,” Rowbotham said.

Johnston said PACT will enable its members to weigh in on standard-of-care and make sound judgments related to each trial.

PACT also will address patient recruitment for trials by leveraging shared electronic health records but will rely on other initiatives to actually develop the infrastructure, said Angela Rizk-Jackson, PACT’s program manager. 

Although no tools are available yet to recruit patients with rare diseases, Greenberg said he believes a shared EHR should ease the process, making it possible to identify patients with specific characteristics for clinical trials.

PACT’s infrastructure should enhance recruitment by more easily identifying the number of patients with certain conditions and informing the public about clinical trials, Berglund said.

Narrow inclusion criteria create one of the challenges behind identifying the right patients, Johnston said.

Lastly, PACT will coordinate budgeting for clinical trials among its members, another conundrum for PACT participants because of varying costs at different institutions.

As chair of the Bay Area BioEconomy Initiative, a collaborative effort to accelerate the timeline of drug development, Una Ryan said PACT should serve as a model in other parts of the country for achieving efficiencies in clinical trials and presenting a more powerful voice in the biopharmaceutical industry.

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