Interest Brewing In A One-Stop Platform For Trial Participants
By Deborah Borfitz
March 30, 2021 | A panel discussion on the move toward “platform thinking” in pharma roused lively discussion and exchange with attendees at the recent Summit for Clinical Ops Executives (SCOPE). Interest was particularly high in development of a common platform catering to the needs of patients and disconnected from any drug, protocol, or sponsor. Several other ideas also surfaced for greater pre-competitive collaboration by trial sponsors.
Digital transformation is a tough sell in the pharmaceutical industry, where change agents will be required across the enterprise to help overcome the “power of inertia,” says Hassan Kadhim, global head of clinical trial business capabilities, clinical innovation & industry collaborations Bristol Myers Squibb. New standard operating procedures will also be needed to bring new ways of working into the mainstream.
Companies need to be working with different stakeholder groups to ensure the digital solutions deployed work for key players as well as patients, and not just for trials, says Disa Lee Choun, head of innovation in global clinical sciences & operations at UCB Pharma. The same technology could be used for after care with patients regularly sharing their health information with investigators and clinicians when they are not in a clinical setting. Initiatives in the E.U. are working through public-private partnerships to stand up a single-platform solution, she adds.
Even prior to the pandemic, organizations such as the Innovative Medicines Initiative (IMI), Clinical Trials Transformation Initiative, and TransCelerate were helping to foster pre-competitive collaboration, says consultant Craig Lipset, founder of Clinical Innovation Partners. But “silo thinking continues to get in the way,” he adds, pointing to under-powered master protocols for COVID-19—at least in the U.S.—which have been too small to produce meaningful results.
In the two large mRNA COVID vaccine trials, many participants ended up in the control arm, Lipset says. More of them would have received vaccine rather than a placebo had the two studies used a master protocol with a common control arm.
Smaller companies have meanwhile emerged with innovative digital solutions thanks to nearly $15 billion in venture capital by investors last year, more than double the figure five years earlier, says Mohammed Ali, vice president of digital analytics and performance at GlaxoSmithKline. One example is the Butterfly Health Network, whose technology turns a smartphone into an ultrasound machine and has just gone public. Teladoc did the same thing back in 2015 and its telehealth platform has scaled significantly since the pandemic began.
Ali says he believes the ideal way to build platforms is through apps with common features, which could be branded and customized as needed. This is the expectation of consumers and has been achieved by other industries.
Choun’s vision is a national-level platform, with the buy-in of regulators, where all players come together to collaborate across the continuum of care. Patients would use the one platform to share information with their healthcare providers, pharma companies, and others, she says. It could perhaps also be where trial sponsors share back information from participants who were involved in clinical trials.
Kadhim suggests that for clinical trial purposes sponsors might join forces to do for patients what they have done for investigators and sites with the Shared Investigator Platform of TransCelerate. The idea is to streamline the patient experience, which currently includes the burden of many disconnected digital solutions, he notes.
With the baseline components in place, sponsors could be doing master protocols from a “disease perspective,” says Ali. Another potential opportunity is to create disease-specific databases where patients go to access studies, much as the IMI has done in the oncology area where the screen failures of one study get shared across sponsors for matching to other trial opportunities. At an industry level, this would “allow for the choice and selection to go back to patients for their best fit into a trial.”
Lipset notes that “years back we had a sharing initiative for patients who failed screening,” which involved ePharmaSolutions, CenterWatch, and several pharma companies. “This just makes sense.”
His picture of the future is one where patients opt into the research that is right for them and are connected to their data in a registry, sharing at will information from their electronic health record and wearables as well as their biospecimens. The barrier is lack of consistent infrastructure, which can be at least partially solved with master protocols, Lipset says.
Greater pre-competitive collaboration between companies takes “understanding the links and synergies in the activities and data being looked at and needed in those areas to help outline a way of working,” says Ali. One opportunity worth considering is to “outline patient-centricity as a core element for all sponsors” via an industry-level consortium focused on patient feedback at the disease level.
Another pre-competitive area “ripe for collaboration” is interoperability between sites and sponsors, according to Kadhim. The rise of decentralized clinical trials during the pandemic has “forced all players to evolve and change, including the sites and healthcare institutions. Finding a way together to allow sites to use their systems and bring all that data internally to our workflows would help tremendously in adapting to the new reality.”
Lipset concurs, noting that “introducing new and unfamiliar technology contributes to errors, quality issues, and frustration.” Enabling sites to use their own tech wherever possible would improve the situation, and eConsent would be a “good starting point,” he adds. “Sponsors and CROs can focus on minimum quality standards and interoperability of signatures, dates, and versions.”
Perceptions of “red tape” in establishing collaborations across the commercial and R&D side of the house is due to a lack of traditional synergies in processes, says Adama Ibrahim, director of digital solutions and technology at Novartis. But with the increasing digital transformation of the pharma industry, “many solutions overlap [departments], especially around customer/patient engagement,” she says. “Teams have to leverage learnings [and] know-hows internally to be efficient. Not easy mindsets to change but it is happening.”
Asked to name three major recent achievements that should continue post-pandemic, Ibrahim was quick to respond that “a single eDiary sounds blissful.” Also on her list are dynamic consent (personalized online platforms for the management of informed consent and communication between researchers and participants) and a single interface for trial participants.