COVID’s Wrench in Clinical Research
The COVID-19 pandemic looks more hopeful today than it has in past years, as vaccine- and infection-derived immunity keep reducing illness and death. It’s hard to forget the early days, when officials made emergency decisions and rolled out different non-pharmaceutical interventions (NPIs) across the world to slow the virus’s spread.
Clinical studies across every research field had to make hard calls to halt or terminate work, then deal with a wave of hurdles as COVID-19 kept disrupting progress. Studies that could pivot to remote research approaches felt the least impact on study integrity, costs, and regulatory timelines.
As the pandemic dust settles, researchers need to look ahead and design studies using strategies that support decentralized research — ones that can adapt quickly to a changing landscape.
COVID-19: Where We’re At and Where We’re Going
COVID-19 has faded into the background of most people’s lives, but the WHO and the U.S. government still considered it a public health emergency at the time, with the U.S. planning to end that status. That change affected how Americans access COVID-19-related healthcare, vaccine and testing availability, and government funding for surveillance and societal support.
It’s hard to predict when the mutation rate of SARS-CoV-2 will slow down, or when its activity will become more predictable or seasonal. The highly transmissible omicron variant that emerged in November 2021 spawned many new sublineages, causing repeated waves of infection around the world. These sublineages often carry multiple mutations that can affect transmissibility, virulence, or the virus’s ability to evade the immune system and reinfect people.
The updated booster vaccines available in the U.S. at the time were bivalent vaccines, targeting the omicron BA.4/BA.5 variants alongside the original Wuhan variant. Fewer than 16% of Americans had received the updated bivalent version as of February 2023.(1)
The FDA later voted to harmonize the primary and booster vaccination series, so people starting the primary series would get the most recent vaccine formulation. This mirrors the flu vaccination strategy, where the FDA and CDC meet yearly to decide which variants to include in the fall booster.
SARS-CoV-2 mutates quite quickly, so vaccine effectiveness against symptomatic infection varies each season and likely won’t last long. Still, the goal is to keep the vaccine effective against severe disease, easing the strain on the healthcare system each winter. Next-generation COVID-19 vaccines will hopefully target more stable epitopes that are less affected by viral mutation, or be delivered nasally to build strong mucosal immunity that can stop infection at the source. Several candidates are in various stages of clinical development, but none has been approved yet.
Effect of COVID-19 on Clinical Research
The COVID-19 pandemic upended clinical research in many ways. At the start of the pandemic, hundreds of clinical studies were suspended or terminated, stalling research across many fields. With limited access to clinical tests, care facilities, staff, and personal protective equipment (PPE), resources had to be redirected to handle the healthcare crisis.
Even after some studies restarted, recruiting and retaining participants stayed a challenge. Vulnerable patients, such as the elderly or immunocompromised, hesitated to join research that required them to be around people in hospitals and other traditional research sites. Staffing shortages and sick leave also strained many clinics trying to keep up with study demands.
Many studies had to modify their endpoints and analyses to work around these hurdles and delays. Those delays and lost data opportunities cost researchers millions of dollars and delayed patients anxiously waiting for new treatment options. Studies that could add remote follow-up visits, or go fully decentralized, saw the least disruption to their timelines overall.
The operational strain researchers felt during the pandemic highlighted the need to move away from the traditional framework and adopt strategies that support a decentralized approach. Overall, the pandemic drove a shift in how we conduct research, with more studies than ever building in some remote component.
How Sanguine Helped Keep Research Moving
When COVID-19-related studies started, Sanguine was there to help drive critical research forward with minimal disruption. Backed by generous government funding and regulatory prioritization, COVID-19-related studies boomed in the first two years as pharmaceutical companies raced to find effective vaccines and therapeutics. Our patient-centric approach let us play a key role in that work.
By sending our team directly to the homes of research participants across the United States, we could easily collect the biospecimens COVID-19 research needed. We partnered with numerous pharmaceutical industry leaders on more than 23 different studies, helping move their research forward and deepen our understanding of COVID-19, vaccines, and therapeutics.
Our research model is built to lower the barriers that traditionally get in the way of participation, by reducing personal costs — transportation, lost wages, time — for patients. Our exceptionally high study retention rate and our ability to enroll participants quickly reflect this, saving time and costs for researchers. We take a patient-oriented approach to engaging with our community, building trusting relationships so participants stay well-informed and invested in the research they contribute to.
As COVID-19 disrupted research across every scientific field, we sat at the forefront of the decentralized study revolution and have consistently delivered solutions to meet researchers’ needs. We specialize in remote sample and data collection, sending our team directly to participants’ homes for recruitment and study follow-up. Drawing on our database of more than 60,000 willing research participants, and using targeted recruitment strategies to reach new people, we can enroll participants even from the most difficult-to-reach patient populations.
Whether it’s a once-in-a-century pandemic or a unique disease population, you can count on Sanguine to meet your research needs and set your study up for the strongest chance of success.
References
- Krista Mahr. Three years into the pandemic, nursing home residents are still in Covid’s crosshairs [Internet]. Politico. 2023. Available from: https://www.politico.com/news/2023/02/15/pandemic-nursing-home-covid-00082913
