“With the mapping of the human genome, we just thought overnight we would have treatments that would target a specific patient with a specific genetic profile,” said Ken Getz associate professor at the Tufts Center for the study of drug development at the Tufts University School of Medicine. “But it's taken a long time for that to really influence our pipeline … We're really there at that time now.”
According to Getz, who spoke last month at a WCG Roundtable discussion about clinical trials in the precision medicine era, about half of all drugs across all therapeutic areas are collecting biomarker and genetic data. In oncology specifically, this number is closer to 80%.
“Our pipelines have really changed, and we all sense it,” Getz said, noting the industry shift from a focus on broader, chronic diseases to “highly targeted therapies for rare and orphaned diseases.”
However, this has introduced operating challenges and could potentially increase the complexity of clinical trials. “We're collecting a lot more data now than ever before,” said Getz. “Historically, in a Phase II study we collect about a million data points of information for a chronic disease.”
Now, studies with genetic testing components are looking at 3-5m data points per single protocol. Additionally, Getz said the number of procedures performed has been growing dramatically – 60% over the last decade, which affects complexity across the spectrum at both a scientific and operating level.
“I think it is going to make it a bit more complex,” said Jill Johnston, WCG, president, site activation solutions, “It's achievable, but you need to think about it and plan appropriately for it.”
According to Johnston, several organizations are deciding to add a genetic test to a protocol, “no different than any other laboratory test.” However, as she explained, there is “a lot more thinking that has to be done.”
Thinking about patients, partnerships, and the potential to create transformational value
In response to the challenges and opportunities genetic testing provides, WCG Clinical Services Division and the genetics services provider InformedDNA have formed a strategic partnership. Under the partnership, the companies will create a Center for Genetics and Precision Medicine in Clinical Trials.
The center will support biopharmaceutical companies, contract research organizations (CROs), institutions, and investigator sites with the design and conduct of clinical trials using genetics.
“[P]roviders who are not used to incorporating genetics into their practice may want to start incorporating genetics into their practice, to screen patients as potential candidates for clinical trials,” explained Karmen Trzupek, director, ocular and rare disease genetics services, InformedDNA.
“But it's daunting to think about taking those kind of results and interpreting them, and providing that to the patient,” she added, noting that a big part of the collaboration is around supporting patients and their families.
As part of this, Trzupek commented on the ability of telemedicine to reach across families with a single provide, “in ways that traditional medicine doesn’t.”
“That's indicative of so many new models, where we're actually bringing the trial to wherever the patient can be found, instead of the traditional approach where the investigator, in a physical location defined where research was conducted,” echoed Getz, “it's now far more about the patient's data with the patient at the core.”
Specifically speaking to patient identification, Trzupek said the industry has to spread a wider net, looking for patients and conducting outreach in communities in a much broader setting.
“That means really bringing genetic expertise and support to more community physicians, and community hospitals,” she explained. “By partnering, and using a telemedicine service, you can do that and provide that kind of structure and support to those communities, and start the funnel really wide.”
From a sponsor perspective, Travis Quigley, senior director of clinical development at bluebird bio, also commented on the importance of finding ways to increase the efficiency of clinical trials through public/private partnerships, “using cooperative groups, and using sponsors to really participate in studies that may have five or even ten arms,” he said.
“So that, as you screen patients collectively in one trial, with one consent form, and one operational model, you can funnel patients to the appropriate studies,” he explained. “And that way that could be ten separate trials, with ten separate sponsors.
Putting ten consent forms, ten models, and ten clinical trial resources, that really the efficiency in doing basket or umbrella bucket trials, could really improve the model for not only sponsors but for providers, for institutions, to really streamline the efficiency of conducting clinical research.”
Yet, as the complexity of clinical trials increases, Quigley noted that the probability of success also is increases – as does the potential to transform the lives of patients.
“This opportunity for precision medicine creates the opportunity for transformational value,” he said.
