Sites Will Be Operating in a World Focused on Customization After the Pandemic
A clear focus on hybrid solutions and customization to a site’s needs will be the hallmarks of clinical trials postpandemic, along with a strengthened ability to shorten trial timelines.
Sites’ pandemic experience has not been a particularly rosy one, says Ken Getz, director of the Tufts Center for the Study of Drug Development (CSDD). “We’ve put a tremendous burden on sites to support the adjustments needed for the pandemic.” According to CSDD data, only 45 percent of trials continued business as usual during the pandemic, while 30 percent switched to remote and virtual models. An additional 25 percent were forced to delay trial activity altogether.
Getz called the speed of development in 2020 “remarkable and unprecedented.” Trials for antiviral and anti-infective treatments took an average of 74 months between 2008 and 2018, CSDD data show, while trials of COVID-19 treatments and vaccines have cut that down to only 20 months.
Even before the pandemic, sites knew that the future presented a high level of uncertainty as they grapple with questions about workforce, costs and infrastructure. Sponsors’ increasing introduction of new technologies in coming years also will challenge sites. More than 90 percent of sponsors and CROs surveyed by CSDD in 2019 said they plan to implement electronic clinical outcome assessment systems in the following three years, up from the 2019 level of 21 percent. Electronic data source (e-source) systems and wearable devices also look to boom by 2022, according to survey responses. E-source systems will be used by 84 percent of respondents, up from 38 percent, and mobile health and wearable device use will grow to 76 percent of respondents, up from 29 percent.
Getz believes the lasting impact of the pandemic on sites will be behavioral rather than solutions-based, with a new clinical trial environment marked by regulators’ increased flexibility and willingness to act as partners in research, increased emphasis on collaboration and data-sharing among researchers, and continuing attention to reducing wasted time in the trial process.
“Deployment of specific solutions is an area where you will see more restraint as we look at how they affect ROI,” he says. Individual tools, such as eConsent, telehealth, virtual trials, remote monitoring and wearable devices, will become part of a suite of solutions to be considered, rather than must-have answers to a crisis.
The kind of change Getz foresees — to a hybridized business model that can be customized to sites’ unique needs — will require sites to rethink the way they manage everything from staff training to infrastructure. Does a site need as much fixed infrastructure if it plans to conduct more remote operations? Are there ways to work with other sites and site networks to pool resources? And, ultimately, what will the workforce of tomorrow look like?
Site staff will need new skills, he says, such as the ability to make decisions based on real-time evaluation of data and conduct high-quality communication with participants via technology and other methods. And some sites are realizing they need to get better at using social media for recruiting and retention. New roles may develop, such as data scientist and remote/virtual trial director.
And as trials move away from the traditional site visit structure, sites will need to think about how to bill sponsors for activities, procedures and services that occur outside a site visit. What may be needed, Getz says, is more of a value-based fee structure.
A new hybridized trial model also comes with hidden costs sites must consider when budgeting and negotiating contracts with sponsors. For instance, a tremendous amount of training will be needed for staff that need to take on new technology and for vendors who may be new to clinical research. How will sites be compensated for such costs?
“We can really look at the pandemic response and point to very important achievements,” Getz says, especially a “remarkable and unprecedented” acceleration in development. But when you come down below the 30,000-foot level, you see so many specific areas that need attention.
“The pandemic has not changed any of the fundamental challenges we were measuring before [the crisis] hit,” he says. “The only change we can anticipate is that each one of these [challenges] is increasing.”