COVID’s Wrench in Clinical Research

The current state of the COVID-19 pandemic is more optimistic today than it has been in the past few years, as both vaccine and infection-derived immunity continue to reduce morbidity and mortality. It’s hard to forget the early days of the pandemic when emergency decisions and different non-pharmaceutical interventions (NPIs) were being implemented across the world to reduce the spread of the virus. Clinical studies across all research fields were forced to make difficult decisions to halt or terminate studies, and then had to deal with a myriad of hurdles as COVID-19 continued to impact various aspects of study progress. Studies that were able to pivot to remote research approaches experienced the least impact on study integrity, costs, and regulatory timelines. As the pandemic dust settles, researchers need to look ahead and design studies using innovative strategies that allow for decentralized research approaches which can rapidly adapt to the changing research landscape.  

COVID-19: where we’re at and where we’re going

Although COVID-19 has moved into the background of most people’s lives, it is still considered a public health emergency by the WHO and the U.S. government, with the U.S. intending to end the emergency status by this May. This change will impact how Americans can access healthcare related to COVID-19, vaccine and testing availability, and government funding for surveillance and societal supports. Regardless of this emergency designation, it is difficult to predict when the current mutation rate of SARS-CoV-2 will slow down or when activity will become more predictable or seasonal. The highly transmissible omicron variant that emerged in November of 2021 has led to many new subvariant lineages causing numerous waves of infection around the world this past year. These sublineages often have multiple mutations that can affect transmissibility, virulence, or immune system evasiveness to be able to reinfect people. 

Current updated booster vaccines available in the U.S. are bivalent vaccines against the omicron BA.4/BA.5 variants in equal proportions with the original Wuhan variant. Unfortunately, less than 16% of Americans have received the updated bivalent version as of February 2023.(1) Most recently, the FDA voted to harmonize primary and booster vaccination series, so that those starting out the primary series would be receiving the most recent vaccine formulation. This approach will be in line with the flu vaccination strategy, with the FDA and CDC meeting yearly to determine what variants should be reflected in the fall vaccine booster rollout. Unfortunately, the SARS-CoV-2 virus mutates quite rapidly, so vaccine effectiveness against symptomatic infection within each season will vary and likely be short-lived, but the goal is that the effectiveness against severe disease will persist and help reduce the strain on our healthcare system each winter. Next generation COVID-19 vaccines will hopefully be designed against more stable epitopes less likely to be affected by viral mutagenesis or will be delivered nasally to generate strong mucosal immunity, capable of stopping viral infection at the source. Although there are several candidates in various stages of clinical development, none have yet achieved regulatory approval.      

Effect of COVID-19 on clinical research

The COVID-19 pandemic upended clinical research in numerous ways. At the start of the pandemic, hundreds of clinical studies were suspended or terminated, stalling research across numerous fields. With limited access to clinical tests, clinical care facilities and staff, and personal protective equipment (PPE), resources had to be reallocated to deal with the healthcare crisis. Even as some of these studies restarted, recruitment and retention of participants remained a challenge. Vulnerable patients, such as the elderly or immunocompromised, were hesitant to engage in research that required them to be exposed to people in hospitals and other traditional research sites. Staffing shortages and sick leave also impacted the abilities of many clinics to meet the demands of their studies. Many studies had to modify endpoints and analyses to account for these hurdles and delays. These delays and lost data opportunities have cost researchers millions of dollars and caused delays for patients anxiously awaiting novel therapeutic options. Studies that were able to incorporate remote follow-up visits or a completely decentralized research approach experienced the least disruption in their timelines overall. The operational burden that researchers have experienced during the pandemic has highlighted the need to move away from the traditional framework and implement novel strategies that allow for a decentralized approach. Overall, the pandemic has ushered in a paradigm shift in how research is conducted – with more studies than ever choosing to incorporate some remote components into their studies. 

When COVID-19-related studies started, Sanguine was there to help drive critical research forward with minimal disruptions. Bolstered by generous government funding and regulatory prioritization, COVID-19-related studies boomed in the first two years as pharmaceutical companies raced to identify effective vaccines and therapeutics. Our unique patient-centric approach allowed us to play a pivotal role in COVID-19-related studies. By deploying our vast team directly to the homes of research participants across the United States, we were able to easily collect vital biospecimens needed for COVID-19 research. We partnered with numerous pharmaceutical industry leaders on over 23 different studies to help propel their studies forward to further our understanding of COVID-19 and develop vaccines and therapeutics. Our research model is built to reduce the barriers traditionally linked to research participation by reducing the personal costs (transportation, lost work wages, time spent) to the patient. This is exemplified by our exceptionally high study retention rate and our ability to enroll participants rapidly, saving time and costs for researchers. We employ a patient-oriented approach when engaging with our community to build trusting relationships so that participants are well-informed and invested in the research they contribute to.

As COVID-19 disrupted research across all scientific fields, we sat at the forefront of the decentralized study revolution and have been able to consistently deliver innovative solutions to meet the needs of researchers. We specialize in remote sample and data collection by deploying our vast team directly to the homes of participants for recruitment and study follow-up. By leveraging our database of more than 60,000 willing research participants, while also using innovative recruitment strategies to reach new individuals, we are able to enroll participants for even 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 chances of success. 

References

1. 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