Clinical trials are changing – for good

In healthcare, the world of clinical trials seems to be up for some big moves – and permanent ones at that, HRI predicted. “In the face of a pandemic that seized nearly everyone, from patients to clinical trial coordinators, to stay home, at least momentarily, pharmaceutical and life sciences companies have been challenging: How much can be done remotely?” the report read. “Quite a bit, it turns out. Overcome to minimize in-person clinical trial visits, these organizations are now trying to find ways to conduct trials with few in-person interactions.”

The COVID-19 crisis has developed an appetite for change across the industry as sponsors, contract research companies, and patients see benefits in a more decentralized pattern. To be sure, the virtual trial is not a new thought: One team of researchers included more than 1,100 trials stated on ClinicalTrials.gov applying connected digital products for remote data collection in both 2017 and 2018, is has been recognized.

“Still, the change to more decentralized, virtual studies has experienced a powerful force during the pandemic,” the report said. “Regulators, for their part, have tried to mitigate the way for a pivot to virtual during the public health emergency. In March, as countries were issuing stay-at-home orders, the FDA issued pandemic-specific guidance for trial sponsors, institutional evaluation boards and investigators on how to ensure the safety of their experiment participants and reduce risks to trial integrity, while sustaining acquiescence with good clinical practice.”

The FDA is suggesting that some of these changes could be here to stay. “Being a clinical trialist of my own from the cancer world, I can understand where some of the things we have adjusted to in routine clinical practice during COVID-19 could then be parlayed into approaches in clinical trials,” stated FDA Commissioner Dr. Stephen Hahn, a radiation oncologist, while the BIO Digital Conference hosted by the Biotechnology Innovation Organization this past June. “That could certainly help us expedite, and maybe we get that cycle time even shorter if we use some of these processes moving forward.”

HRI recommended that clinical trial organizations determine the right studies that can be set up for victory in a decentralized trial model. “Sponsors should recognize and prioritize disease areas that are more conducive to enrolling patient populations through decentralized models,” HRI recommended. “This likely will include understanding the feasibility of running studies in non-conventional situations that can adequately facilitate patient visits, drug storehouse and bio-specimen collection. Also, not every therapeutic field is expected to have the same opportunity to virtualize trial components.”

Companies need to set up the operations and infrastructure, the report said. “Traditionally, the sponsor and CROs have shared responsibilities in monitoring and overseeing clinical trial sites.” The report stated. “These methods have been simplified through risk-based, data-driven approaches that have overcome the dependence on 100% source document verification.

Until now, the healthcare industry has concentrated more on the ease and simplicity of technology solutions for customers and less on the clinicians who treat them, HRI contested. That may be changing in 2021, it prophesied.

Well before the pandemic, many doctors were already tired and burned out, spending too much time on administrative tasks and wanting more from digital technology, especially electronic health records systems, according to the report. They still wrestle with unlimited drop-down menus, alerts, and regulatory reporting obligations that sap their efficiency and ability to present a good experience for patients, it said.

“Sixty-two percent of physicians acknowledging to a 2018 survey by the Physicians Foundation found that problems such as third-party authorizations, treatment protocols and EHR design were hurting patient care,” the report declared. “And now with telehealth going mainstream as a byproduct of the pandemic, they also are stimulated to meld the virtual and in-person care worlds in a bigger way than ever.” Healthcare organizations can attain efficiency with better digital relationships, the report suggested. The pandemic may have stimulated payers’ efforts to reduce physicians’ administrative responsibilities, it added.