ePRO eCOA eSource DDC

How Real-Time Data Can Expedite Infectious Disease Clinical Trials

For infectious disease studies of any kind, the ability to accelerate trial timelines, while also providing high-quality data and reducing barriers to patient participation, is highly prized. And when the World Health Organization (WHO) declares a virus a pandemic, there’s no time to lose. Infectious disease drug developers must respond immediately to find treatment and prophylactic candidates and rapidly move them through the drug development process.

The COVID-19 vaccines are an example of what can happen when government and industry work together to fight an infectious disease. As SARS-CoV-2 spread across the world, researchers raced to develop effective vaccines, diagnostics, and treatments. Timelines that usually last up to 10 years condensed to less than twelve months, and the FDA granted Emergency Use Authorization in record time.

Drug development during COVID-19 showed us how digital technology can help clinical trials stay on track during times of extreme disruption. Videoconferencing, mobile technology, and remote patient monitoring allow patients to participate from anywhere. And real-time access to direct data capture (DDC), electronic patient-reported outcomes (ePRO), and electronic clinical outcomes assessments (eCOA) provides study teams with immediate insights and interim analysis reporting.

The Lunexis™ eSource Ecosystem supports telemedicine, mobile device strategies, eCOA, and more, all while providing near-immediate data access. Here’s how one client used Lunexis™ to overcome an especially difficult situation.

The Challenge: Accommodating Older Adults During a Pandemic

A leading pharmaceutical company planned a Phase III trial for a SARS-CoV-2 prophylactic to protect against COVID-19. The company initiated the study to evaluate post-exposure prophylaxis and pre-emptive treatment in 1,000 patients spread across 82 sites. There were a few snags: The patients were all over age 60 and lived in long-term care facilities. Some may have been exposed to the virus. To lower the risk of these patients either contracting the virus or passing it on to others, they could not visit off-site clinics in person. Complicating matters further, they also couldn’t use telemedicine.

The Solution: Remote Data Collection

To help the sponsor get the required data, we developed a plan that allowed traveling coordinators and nurses to collect data remotely from a variety of sources. This plan enabled clinicians to capture patient data directly into the electronic record using Lunexis™ including supporting information such as handwritten notes and photos of drug dispensation records.

Using our plan, participants could fully participate in the trial without leaving their communities. The sponsor not only kept its clinical trial on track, but it also completed study startup in 10 weeks, substantially quicker than through traditional methods.

Why It Worked

When running infectious disease studies, speed and infection prevention are dually important. eSource DDC, ePRO, and eCOA all help sponsors generate the data they need in real time — with less face-to-face interaction.

Near-immediate data access allows study teams to respond right away when a patient’s health status changes. Lunexis™ also has the flexibility to accommodate changing patient needs. When in-person site visits aren’t possible, patients still have a way to participate. And when a pandemic requires clinical trials to scale back or eliminate in-person everything, sponsors can use DDC to enter and remotely monitor data.

Infectious disease studies often require heightened attention to infection prevention as well as equipment that can function in non-traditional settings. Practicalities such as applications that can work online or offline, the ability to collect multiple forms within a patient’s chart across different tablets, easily sterilized stylus and tablets, and glove-compatible data entry give users options. Whether your study takes place in mobile units, an ambulatory center, or in remote medical tents, Lunexis™ is ready.

Even when there’s not a pandemic, the Lunexis™ eSource Ecosystem provides the flexibility needed for rapid response. Better quality data, faster trial execution, and study access to a broader group of patients also benefit infectious disease studies.

As we’ve learned over the past year, it’s difficult to predict the course of a virus or when a new virus will emerge. When every day matters, eSource DDC will help you deploy studies faster and get to database lock sooner, setting you on the path to earlier prevention and treatment. To learn more about how Clinical Ink helped this sponsor deploy a study in 10 weeks under challenging conditions, download our case study: Leading Pharma Takes Control of Infectious Disease Trial With Real-Time Data.

Topics: ePRO, eCOA, eSource DDC

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