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The Impact Of COVID-19 On CROs And Infectious Disease Trial Operations

CROs with infectious disease expertise quickly took the spotlight in 2020 when COVID-19 necessitated the swift development of safe and effective vaccines. Unlike ever before, efficient and high-quality CRO services were in urgent demand. The clinical research community, particularly infectious disease CROs, had to adapt moment by moment to find solutions on behalf of Sponsors.

The operational innovations that took place as a result of COVID-19 did not just apply to that immediate time of need. Now, in a world permanently altered by the effects of a global pandemic, we must continue to change how we operate to match the needs of Sponsors and patients long-term.

How CRO Services Are Adapting to Meet Greater Demand for Treatments

The demand for vaccine development spiked practically overnight after COVID-19 was declared a pandemic. One of the first challenges made evident in vaccine trials was the need for swift patient recruitment with ambitious enrollment targets. Last year, we discussed the patient recruitment challenges for infectious disease trials and the solutions that CROs can offer for managing clinical trials under such unusual conditions.

But in reality, COVID-19 exposed vulnerabilities that existed long before the pandemic. Historically speaking, vaccine development for infectious diseases tends to last between 5 and 10 years^[1]. Complex regulatory environments elongate the research process, especially in multinational studies where multiple regulating bodies have bearing on the trial. There are also a unique set of ethical considerations that arise from the high stakes of pandemics and other urgent health crises.

It’s time we devote attention to all infectious diseases with the urgency that brought us COVID-19 vaccines in under a year. To accomplish this, infectious disease CROs are strengthening and adapting their existing set of services according to rapidly-changing standards, strategies and regulations in the industry.

The Value of Risk Based Monitoring for Infectious Disease Trials

In a recent review screening data from 76 articles across six databases, the authors identified the most-cited clinical research challenges in responding to emerging epidemics and pandemics, as well as key actions to address them. Among these recommended actions is the need to “establish accelerated pathways for regulatory and ethical joint approvals."^[2]

Regulatory challenges are among the most significant impediments to infectious disease trials. Traditional methods of ensuring regulatory requirements are met takes more time and resources than most other components of research. The good news is that new strategies hold great promise for the goal of expediting the regulatory process, and infectious disease CROs are beginning to adopt them. Risk Based Monitoring (RBM),^[3] for example, uses risk mitigation methodologies to maximize the efficiency and quality of data collection, management and analysis. Since RBM allows for much more targeted data monitoring, it stands as one of the best ways to shorten timelines in the drug development process while preserving data quality.

Accelerating the Shift to Decentralized Clinical Trials

During the pandemic, the best CRO services for patient engagement have been those that allow trial participants the most flexibility possible. Decentralized Clinical Trials (DCTs) are extremely appealing to patients because of their safety and convenience. DCTs also offer unique benefits to those managing clinical trials — for one, conducting trials virtually almost always helps widen and diversify the pool of participants.^[4] The way these trials are conducted usually also helps lower the participant dropout rate, which can be quite high in traditional trials.

There are significant challenges to address with decentralized trials. Currently, there is little standardization in how DCTs are designed and conducted. Thought leaders on this topic advise closer collaboration among the pharma and clinical research community, trial participants, regulating bodies and technology innovators.^[5]

Although it is far from a universal model, it is reasonable to presume that DCTs will become more and more prevalent as time and technology progress. Motivated by a need and inspired by recent progress, CROs for infectious disease trials are helping to lead the charge in transforming how these clinical trials are conducted. While full decentralization may not be achievable in all regions and circumstances, any efforts to adapt trials to the lifestyles and needs of patients can help improve clinical research outcomes.

Rapid change has always been inherent to clinical research, and the pace is quickening with time. Infectious disease trials are a growing focus for the industry and require creative, nimble thinking to find the right solutions. If you would like to find out more about how we can meet the complex needs of your clinical trials, we would love to hear from you.