Leveraging Decentralized Real-World Evidence (RWE) Data Collection Strategies During the COVID-19 Pandemic and Beyond

The COVID-19 pandemic has affected every aspect of our lives, including clinical and real-world studies. Patients often cannot visit sites for various assessments, and there has been an impact on patient recruitment and retention rates. While patient safety is top priority, the collection of study dictated data is critical. To do this, we’ve developed strategies to ensure patient safety in the current global scenario and mitigate the impact on study disruption. In this blog, Mariah Baltezegar, head of consumer health and peri- and post-approval study innovations, real-world evidence at Evidera, discusses strategies to address these existing challenges, as well as how the application of these approaches extends beyond the current pandemic.

Strategies to bring a study to the patient

Given the constraints of COVID-19, it is often preferable to conduct a fully virtual, decentralized or metasite approach, where it’s not necessary for a patient to visit a research site for assessments. Fortunately, there are short-term and long-term solutions available either individually or collectively in a metasite model leveraging a digitally enabled platform.

• Televisits enable healthcare providers to physically see a patient and perform assessments via video conference for both standard of care and protocol defined assessments. This is being applied both to research activities as well as routine healthcare.
  
• Remote e-signature consent can be employed to acquire remote consent signatures for patients who do not have the appropriate consent in place or cannot visit sites to be consented. It’s important to note that issues related to consent are continually evolving.
  
• Direct to patient approaches, such as electronic clinical outcomes assessments (eCOAs), electronic patient-reported outcomes (ePROs), devices and wearables, and home nurses and phlebotomists are options for patients who cannot visit their study site for in-person assessments.  
  
• Direct to patient supplies provide study medication or other supplies necessary to conduct study assessments via direct shipments to the patient’s home when patients are unable to visit a site to replenish their clinical supplies.

With the metasite model, the burden is removed from the site staff who may be involved in frontline care during this pandemic and bring the study directly to the patient, allowing them to participate from the comfort of their homes.

Additional strategies for REAL-WORLD EVIDENCE data collection

There are other strategies that minimize burden on patients, caregivers, and healthcare providers that may meet some of the needs brought on by COVID-19. Electronic medical record (EMR) extraction uses existing health information exchange technology to connect clinical sites’ EMR data and pre-enable them for research. This streamlined approach can eliminate the need for site staff to perform data transcription and free site staff to perform other activities while enabling continued data collection.

Alignment with integrated delivery networks (IDNs) allows recruitment of patients at the point of routine care versus traditional research centers. This strategy utilizes large healthcare delivery organizations that either own or manage multiple points of patient care (e.g., hospitals, physician practices, long-term care facilities), allowing for rapid feasibility as well as patient identification through centralized EMRs and enabling e-recruitment of potential patients or study participants. Existing registry data can also be leveraged to map study objectives, assessments, and measures across data sources. For example, the existing data sets being collected on COVID-19 in various geographies and formats and for various purposes can be used to answer research questions.

Beyond the current pandemic  

We need to be thoughtful and practical around collecting data in the current environment, while at the same time considering novel and alternative options to ensure clinical and real-world studies can continue. Globally, regulatory and data privacy guidance is evolving to address the current challenges faced by the industry. While specific guidance and actions may differ among regulatory agencies and ethics committees, it’s clear that patient safety comes first.

Decentralized solutions have been prioritized across the industry to address immediate needs for COVID-19 studies and other studies disturbed by the effects of the pandemic, but these solutions hold longer term potential. Outside of the current, urgent needs that digital solutions are helping to alleviate, these strategies offer the future standards for study development and allow greater patient access and interactions that will expand the possibilities for future research.