2020 was Rough, But Ushers in Changes Long Sought by Trials Industry
The impact of COVID-19 will continue well into 2021, and sites and sponsors already are looking at how new methods, new collaborations and lessons learned during the pandemic can be applied in the years ahead to reduce trial costs and timelines, increase participation and strengthen electronic solutions to make trials more effective and efficient.
The silver lining to the COVID crisis is that it kick-started moves that the industry has debated, but also coveted, for years.
The pandemic didn’t cause new problems as much as it exacerbated decades-old issues, says Megan Trost, vice president for study startup and administration at WCG Clinical. Because of the urgent need for new vaccines and treatment, sites and sponsors have been forced to find ways to accelerate startup and smooth out budget issues, she says.
The result, Trost said, is a reduction in the number of business days needed for contracting activities, such as budget development and negotiations, contract negotiations and review, and coverage analysis. She cited WCG data that shows budget negotiations for COVID-19 trials, compared to nonCOVID-19 trials, had been reduced by 32.3 days, meaning they were conducted 4.5 times faster. Contract negotiations and coverage analysis took 23.9 and 7.1 fewer business days and were conducted 2.8 and 5.9 times faster, respectively.
Many studies were completely negotiated and fully executed within 24 hours from receipt of documents. “This requires all parties having a vested interest in speed,” Trost said.
WCG data show that of 225 nonCOVID-19 trials that began during the first nine months of 2020, half had their start date delayed at least once, and studies were delayed overall an average of 6.07 months. WCG also found that 25 percent of studies that were launched in April were for COVID-19 research. That figure dipped slightly to 23 percent in May and 14 percent in June. Fifteen percent of studies that began in October, the most recent month with available data, were for COVID-19 studies. New studies in oncology, cardiovascular and central nervous system research all posted large declines in 2020.
As a result, sites have been more receptive to staff augmentation to make up for staffing shortages and furloughs, Trost said, while pushing to address bandwidth issues and to start nonCOVID-19 trials, especially in oncology.
Mike Cioffi, a senior vice president for clinical solutions and strategic partnerships at WCG, said the pandemic “quickly made our industry pivot from traditional ways of thinking to challenging ourselves to be innovative and provide new solutions to the problems we’re now facing.” That includes the use of remote clinical research coordinators at sites which, according to WCG data, increased from 15 percent of trials before the pandemic to 61 percent during. “We’ve seen enrollment increase as much as 46 percent in some of the trials and look to see this continue into 2021,” Cioffi said.
Trial staffing also is on the cusp of change, agreed Jonathan Zung, WCG president for sponsor and CRO programs. “I believe we’re going to see more sponsors providing additional clinical research coordinator resources to sites to assist them with activities, such as patient engagement and retention, as well as data entry, given the furloughs and layoffs that have occurred in research sites and the ones that are continuing to occur,” he said. He also expects to see more home nurse visits for tasks like blood collection and the administration of trial medications.
In addition to ways to augment trial staff, the pandemic has shown the need for restructuring traditional roles, according to Melissa Bomben, a senior vice president of clinical solutions and strategic partnerships at WCG. Instead of clinical research personnel handling such disparate tasks as data analysis, regulatory compliance and research documentation, roles are becoming more specialized.
“The trend toward specialist vs. generalist skillsets is accelerating in response to the increasing complexity of clinical research conduct and significant changes in practice in the pandemic era,” Bomben said. “Augmentation of clinical trial site resources with specialists has alleviated burden on clinicians, increased access to clinical trials for patients, and improved site performance.”
But, noted David Russell, director of site strategy for WCG PFS Clinical, not all sites that experienced layoffs and furloughs have regained that staff, and their trials continue to lag. “Due to these changes, we saw a tremendous decline in enrollment for numerous trials and the ability to start new studies diminished,” Russell said.
Reduced revenue during the pandemic has made it difficult to bring back trial staff, he said. “What I’ve seen is that many of the positions not being brought back are administrative in nature.” And the lack of staff in these areas, which include data entry, legal clinical trial agreement review, coverage analysis, budget and contract negotiations, and sponsor billing, is “beginning to put research sites in danger of noncompliance, not collecting the funds they are owed and not negotiating for all the funds needed to be properly reimbursed for the expenses involved in a study,” Russell said.
The pandemic also has caused a change in the way drug safety monitoring boards (DSMB) operate, said WCG’s Chief Scientific Officer Jonathan Seltzer, putting more pressure on them to respond quickly.
“The pandemic has forced the DSMBs to be far more responsive, faster-acting and more comfortable with alternative clinical trial scenarios,” he said. “These COVID-19 trials, unlike those trials for more established diseases, require a more rapid evaluation of whether or not a given therapy shows promise,” he said. “This has put additional types of pressures on DSMBs, which in the past met every three months, in general, to review data.”
Lori Abrams, executive director for patient advocacy and diversity at WCG, sees in the pandemic an opportunity for the clinical trials industry to ask whether it invested in “reasonable and fair” access to prevent, mitigate and treat COVID-19 in underserved communities. “Regardless of whether minorities and [the] underserved are at a higher risk or not, it’s another opportunity to take a look at ourselves in the industry and decide if we’re doing enough to bring awareness and accessibility to our clinical trials,” she said. “I think it’s a time where we can get together with those who had challenges enrolling COVID-19 patients and see what worked and what didn’t work, and what we should try together differently.”
According to Abrams, several sponsors “have initiatives with large amounts of money to diversify both patients and clinical investigators. As sponsors see success in increasing their diverse populations, they may begin to realize that they can execute on budget and still make their timelines while adding new sites and new geographic locations to their repertoire.
“Diversifying the clinical trials and achieving equity, however, will not be resolved by a few sponsors or sites changing how they work. Rather, it requires industry as a whole to move in the same direction,” she said. “Community outreach, education, creating centers of excellence, including the voice of the diverse patients in drug development, and increasing partnerships with local physicians are not all-inclusive, but they are a good start.”
The use of clinical trial technology also has received a much-needed boost during the pandemic, which “has demonstrated to sponsors and investigators that remote solutions are not only viable, but quite well suited for clinical research,” said Zung. The use of e-technology, telehealth, remote visits and artificial intelligence across the clinical trial space “are here to stay,” he said. “This is going to have a profound impact on the design of trials going forward.”
Technology has helped the industry overcome one of the biggest challenges faced during the pandemic: conducting informed consent procedures when trial staff can’t meet with participants in person. “The events of 2020 caused research sponsors and sites to quickly adapt to the reality that physical access to potential research subjects would be limited,” said David Borasky, WCG’s vice president of IRB compliance.
Telemedicine platforms, electronic informed consent applications and e-signature software have allowed informed consent activities, including obtaining consent for changes in research, to continue even when researchers and participants could not be in the same room, Borasky said, and the benefits of this approach make it a viable option for the future. “Remote informed consent reduces the research burden on potential participants without compromising the integrity of the consent process while maintaining compliance with all regulatory and ethical requirements,” he said.
Looking ahead to 2021, Zung said that while COVID-19 vaccines are on the horizon, surges of the disease will likely continue in the new year. “It’s going to be critical to focus on trial planning and execution, knowing the constraints that are in place due to the pandemic,” he said. “On the trial planning side, it will be important to ensure that appropriate efforts are placed on identifying and selecting those sites that have the necessary resources and capabilities in place to support conventional and hybrid trials under COVID-19 constraints.”