The COVID-19 pandemic is affecting every aspect of life and business, but few fields have to gird for its long-term impacts as clinical research does.
The novel coronavirus outbreak has disrupted months of clinical trial data, wreaked havoc on research budgets, and revealed some things that will need to change in the designs and administration of future clinical trials.
Below are some of the long-term impacts on clinical trials that are starting to emerge from the COVID-19 pandemic.
As the world became aware of how dangerous the novel coronavirus could be for many people, and as shelter-at-home efforts got underway, clinical trials around the world slowed — and in some cases, came to a halt.
The problems were manifold. Participants were unable or felt unsafe traveling to continue their participation. Further, the potential introduction of COVID-19 infections into ongoing clinical trial research was going to complicate the data.
Consider trials focused on mental health, as Yale School of Medicine psychologist Lynnette Averill notes in an interview with Science magazine. “A global pandemic where you’re isolated and potentially have fears of you or your family being ill … those things are highly stressful, and potentially traumatic,” she says.
In such trials, Averill says, researchers might have to compare pre- and post-pandemic cohorts to isolate COVID-19’s impact on that data.
Laurie Burke, founder of the consultancy LORA Group, tells Clinical Trials Arena that this could have a significant impact on patient-reported outcomes, especially in trials that explore “psychiatric conditions that affect children and teenagers, who like routine.”
Beyond simply complicating trial data, however, COVID-19 has already forced many researchers to suspend their trials, Mike Richards, Michael Anderson, Paul Carter, Benjamin L. Ebert and Elias Mossialos write in the journal Nature Cancer. The consequences of suspending thousands of ongoing trials cannot be overstated: Work toward treatments and therapies stops, patients stop receiving certain treatments, and research teams might struggle to secure funding to resume those trials once it's safe to do so.
The world’s development pipeline for pharmaceuticals and other treatments was pinched shut, if only temporarily. It remains to be seen exactly what effects that has on medicine, but it’s safe to say this has squeezed research organizations, their operations and their budgets.
Small biotech companies, for example, are facing cash flow issues that could hamper future work — as well as the viability of those companies, Angela De Martini, Dean Lockhead, Leandra Plappert and Elizabeth Rountree write at Clinical Leader:
“Delays in clinical trials may lead smaller companies to need additional funding at a time when their stock values have likely dropped and market conditions are not optimal. Many companies may be forced to make difficult cuts or prioritize development opportunities. Companies with potentially high-value products and platforms may be at risk of acquisition based on unfavorable terms.”
Furthermore, researchers find themselves in vulnerable positions because of budgetary constraints. In April 2020, researchers David G. Kent, David J.H.F. Knapp and Nagarajan Kannan surveyed 762 researchers from around the world to understand how COVID-19 has impacted their work and their careers.
Respondents, especially the younger scientists, reported that their research organizations hadn’t done enough to assure the scientific community that currently funded research would continue. Grant competitions have been delayed, researchers are concerned that deeper economic troubles are on the horizon, and all the while deadlines are passing by. Researchers are therefore worried whether there will even be work for them in the near term.
That is ominous footing for the resumption of clinical research.
In the early weeks of the pandemic, many of the regulatory agencies that oversee their countries’ clinical trials began to offer “new guidance on how sponsors should manage ongoing clinical trials and launch new ones,” Paul Bridges and Sheela Hegde of Parexel write at Contract Pharma.
That guidance gave “sponsors greater independence in how they maintain compliance during this emergency,” Bridges and Hegde write. Granted, these moves were intended to remove friction for researchers seeking a vaccine or other treatment for COVID-19, but precedents have been set.
“Once sponsors and CROs master this new regulatory environment – which has the potential to create new efficiencies, shorten response times, and reduce costs – there will be little incentive – scientific, operational, or financial – to return to old ways of operating. That genie is out of the bottle.”
One aspect of clinical research that’s seen a door open is the virtual trial. Phesi founder and president Gen Li tells Pharma Technology Focus that innovations such as virtual placebo groups could bring new efficiencies into future R&D.
Li’s point echoes the feelings of many researchers that the COVID-19 pandemic has created an opportunity for clinical trials to embrace technology and fold those into the core designs of trials.
In March 2020, the American Society of Clinical Oncology surveyed members and partners about the challenges they were facing during the early days of the pandemic. David M. Waterhouse and R. Donald Harvey were the first authors on that summary paper. That survey found most respondents saw telehealth and remote patient monitoring as clear ways to improve future clinical trials.
In June 2020, Sheila Rocchio at MedCityNews argued that “[c]onnecting patients to researchers, no matter where they are, is now more important than ever.” Rocchio cites remote monitoring via wearables and telehealth, as well as at-home visits, as necessary innovations for future clinical research.
If regulatory doors continue to open, then the next challenge is a practical one. “This means that advancements in clinical development depend heavily on how the pharmaceutical industry further leverages digital capabilities and automation,” Rocchio writes. “Information that is increasingly collected remotely must be mapped, standardized and reviewed efficiently.”
In another June 2020 paper, Stephen E. Kimmel and co-authors argue that clinical research has demonstrated “substantial aversion to innovation in normal times,” but that the pandemic has exposed many of the inefficiencies that have flourished as a result. Those researchers prescribe remote processes such as remote informed consent and the use of EHRs to facilitate followups in addition to better use of research networks to scale and coordinate concurrent trials.
“The research landscape around COVID-19 has served as a magnifying glass on the problems noted earlier, with the cost of inefficiencies—in terms of delayed answers and continued deaths—being brought into sharper focus than with perhaps any past disease,” they write.
It’s clear that risk calculations and budgets will need to be reassessed when clinical trials resume at or near the capacity they were operating before March 2020.
The companies that can build flexibility into their operations might be the ones best-positioned to succeed, De Martini et al. at Clinical Leader write: “Sponsors will need to balance patient safety, trial integrity, and statistical power considerations against funding and revenue issues on a trial-by-trial basis. In addition to reevaluating clinical development plans, companies may need to reassess their assumptions around pricing and revenue as well as the competitive landscape for both their pipeline and in-line products.”
This means whole pipelines will need to be reevaluated, and priorities could be reassigned based on the new realities that emerge from the pandemic. Each CRO will have to do those calculations independently, as each organization’s circumstances will be different.
That said, the CROs that can most quickly assess the risks and opportunities available to them post-pandemic set themselves up for success in the long term.