‘You Need a Village’: Clinical Trial Leaders Discuss Collaborations, COVID, and Widening the Lens
Experts came together on Clinical Trials Day to discuss why early and frequent discussions among all stakeholders are necessary, how COVID forced the industry to think “more clearly and sharply about doing things remotely,” and what factors are critical to designing and implementing clinical trials.
Walter Stadler, Fred C. Buffett Professor of Medicine and dean for clinical research at the University of Chicago, moderated the discussion, which featured leading physician-researchers and life science executives who are driving medical innovation forward through clinical trial partnerships.
These partnerships with the right collaborators are necessary in order to design and execute a clinical study, said Julian Solway, Walter L. Palmer Distinguished Service Professor of Medicine and dean for translational research at UChicago. Having input from a community of stakeholders “from the very onset” also helps ensure that any potential issues are considered upfront. “All of this should be done right from the onset,” stressed Solway.
Early and frequent discussions among all stakeholders are especially important given the number of those involved and the various needs and goals of a particular trial.
As Sonali Smith, Elwood V. Jensen Professor of Medicine, UChicago, explained, “Sometimes you find that what is the bottom line for pharma is very different from a patient or an academic investigator.” This makes things “tricky,” she said. “Getting all the stakeholders together is so important.”
The need for collaboration is increasingly important with the availability of next-generation sequencing and its ability to characterize diseases into smaller and smaller subsets.
“Each individual cancer is overall a less common disease and they are becoming even more and more divided,” explained Smith. “When you have fewer numbers [of patients] having a culture of collaboration is very, very important,” explained Smith.
A board-certified hematologist-oncologist and professor of medicine at the University, Olatoyosi Odenike noted that relative to solid tumors, hematologic malignancies are even less common. “With the advent of next-gen sequencing technology we can now subdivide the various diseases of interest that we treat into even smaller subsets so the pie is getting increasingly smaller,” she said.
“That calls therefore for greater collaboration – being able to design trials that are relatively smart, being able to get other institutions to collaborate with us knowing that these days one site can’t do it all, even a large referral site,” Odenike added. “You need a village to be able to get the trials up and running and get the answers to the questions that our patients so eagerly deserve.”
In that regard, Odenike said the Personalized Cancer Care Consortium (PCCC) is “a near-perfect mechanism” for conducting multi-site trials. “We’ve been able to divide things by program into disease and that has helped have many teams,” said Smith, speaking to scaling. “Having a good coordinating center to help with the data collection and the quality is incredibly important.”
A clinical research group based at the University of Chicago, the PCCC includes a network of six academic and community-based cancer clinics and hospitals in the Chicago Metro area, Central Illinois, and Northeast Indiana. Additional sites are able to participate in trials coordinated through the PCCC with approval from an advisory committee. This structure has enabled the consortium to successfully engage industry partners and run multi-site trials.
Among its partners is AbbVie, which collaborates for a multitude of reasons, said Ellen Bolotin, executive medical director and global development leader at AbbVie. “We want to deliver to patients the best medicine… Working together with Chicago area physicians and institutions is very important,” Bolotin said. Partnerships help the company “see where the gaps are,” fill these gaps, and critically anticipate the evolution in healthcare, she added.
“The biology is moving at a very rapid pace, and the ability to translate what’s happening at the bench into something we can test in the clinic and return back to the bench, that circular and mutually beneficial relationship with scientists and translational work that is being done has been very robust in cancer and oncology,” noted Smith.
Still, there hasn’t been a “recipe” for the drug discovery and development process, said Krishna Balakrishnan, deputy director, Office of Strategic Alliances, National Center for Advancing Translational Sciences (NCATS). Historically, there often was a gap between scientific discovery and patient value, which is why NCATS was established. To address this, NCATS compiled over a decade “validated procedures, recipes, assays that people can use.” The free Assay Guidance Manual (AGM) is a best-practices resource for the development of robust, early-stage drug discovery assays.
Most recently, the “big issue” NCATS faced was worrying about rare disease patients who had to go to several locations to find specialists during the pandemic. “We needed to increase our capabilities in telemedicine,” said Balakrishnan. “[COVID] forced us to think more clearly and sharply about doing things remotely.”
The other panelists echoed this shift driven by the COVID-19 pandemic. “The pandemic forced us to be more efficient,” said Smith. “When you write a trial on a very simple and practical level everything needs to be done for a reason. I think the pandemic showed us we were doing things we didn’t need to be doing.”
Bolotin agreed that “the protocols could be written simpler,” though there are “lots of requirements from regulatory agencies.” In another industry-wide effort, Odenike noted the push to increase underrepresented minorities in clinical trials.
“Not everybody is the same,” added Solway, speaking to the need to account for several factors that are so-called “upstream of biology and medicine.” These are the social, environmental, and behavioral components – together making up the “sociome.”
“We have to prospectively account for what aspects of the ‘sociome’ are important to be taken into account as we do the study so that we don’t end up with results that are only relevant to say middle-aged white guys and nobody else,” explained Solway. “Accounting for ‘sociome’ factors is a really important widening of our lens as we do clinical research.”
// The Clinical Trials Day event was co-sponsored by the University of Chicago Biological Sciences Division’s Office of Clinical Research, the Institute for Translational Medicine (ITM), and the Polsky Center for Entrepreneurship and Innovation at the University of Chicago.