Case Study: Enabling A New Frontier in Infectious Disease Patient Management with Comprehensive Clinical Data Management

When a patient presents with a fever or what appears to be an acute infection, clinicians face a seemingly simple question: should antibiotics be prescribed or not? Distinguishing between bacterial and viral infections is a major diagnostic challenge because the symptoms are often very similar. Beyond an ineffective treatment for viral infections, prescription of antibiotics, particularly their overuse and misuse, contributes to antimicrobial resistance (AMR).

A leader in the emerging field of advanced host-response technologies, MeMed set out to address this diagnostic challenge. Over the course of a decade, the company developed novel technology that accurately and rapidly decodes the body’s immune response to infection, the ‘host response’, rather than focusing on detecting the presence of a microbe. This allows robust diagnosis when the infection site is inaccessible or unknown, even when the pathogen is undetectable using conventional tests, or when the cause of infection are emerging new pathogens.

MeMed’s “APOLLO” study assessed the diagnostic performance of the MeMed BV® test on the point-of-need platform MeMed Key®, evaluating the technology’s ability to help healthcare providers accurately and rapidly distinguish between bacterial and viral infections. To ensure successful submission and regulatory approval of its study, reduce overall trial costs and add an extra layer of objective quality control, MeMed engaged Bioforum. A data focused CRO with extensive experience in medical device, diagnostic and infectious disease clinical trials, Bioforum was selected to support all data capture and management activities, as well as to provide programming and medical writing support for the clinical study report (CSR).

Challenge

The choice of clinical endpoints and how the endpoint adjudication process is managed can have a major impact on the success of a clinical trial. Cognizant of this, MeMed incorporated an expert adjudication comparator method in its APOLLO study to assess the diagnostic performance of its MeMed BV® test on the point-of-need platform MeMed Key®.

 

When clinical endpoints are subjective or complex to assess, sponsors of research studies turn to clinical endpoint committees (CEC) to demonstrate acceptable safety results to regulatory authorities. CECs reduce variability in adjudicated outcomes, as the clinicians who make up these committees are often experts in the field and apply a consistent, standardized approach to the assessment. However, traditional manual, paper-based approaches to CEC management place significant time, cost, and resource burdens on sponsor organizations. These traditional approaches are also prone to errors and bias, and, as such, often associated with regulatory challenges.

To avoid such hurdles, ensure scientific rigor and an efficient, streamlined CEC management process, MeMed selected Bioforum to set up, implement and manage a technology-based solution that enables real-time visibility of the endpoint adjudication process combined with EDC, to provide a unique, tailor -made solution for the specific study needs.

Solution

Bioforum, a certified Medidata partner, implemented and configured Medidata Rave, the industry’s leading unified electronic data capture (EDC) solution, for MeMed’s APOLLO study. In addition, Bioforum developed and managed an adjudication process strategy that provided additional oversight to avoid disconnected processes and ensure the data presented to the CEC was clean, accurate and clear, in a format that meets regulatory requirements.

To accomplish this, Bioforum designed and executed on a three-tiered approach focused on:

  • Building a tailor-made EDC solution to support study-specific design considerations
  • Customizing a smart report within the Medidata Rave EDC system, which would be uploaded into a designated adjudication platform for review, to facilitate adjudication committee work
  • Providing flexible support for data mapping and queries management to adjust the EDC to specific study needs, including those related to recruitment challenges and effective usage of data from additional studies

Impact

Operating as an extension of MeMed’s internal clinical team, Bioforum met the demand for data management, programming and statistical and medical writing resources. The establishment of a governance structure between Biforoum, MeMed and the technology vendors, enabled Bioforum to proactively anticipate and manage challenges.  Our flexible approach, tailor-made solutions and focus on communication, allowed Bioforum to provide MeMed with clean, high-quality data for adjudication committee reviews, while meeting data lock deadlines.

In September 2021, the FDA granted MeMed 510(k) clearance for use of the MeMed BV® test on the point-of-need platform MeMed Key® to help healthcare providers distinguish between bacterial and viral infections. The technology has been cleared for both children and adults.

We’re proud to have been MeMed’s partner in this exciting journey. Our experienced, cross-functional project team’s ability to streamline the adjudication process, convert the data sets and deliver the submission packages efficiently and cost effectively, meeting all key deadlines, contributed to MeMed’s success in reaching this critical milestone.

In September 2021, the FDA granted MeMed 510(k) clearance for use of the MeMed BV® test on the point-of-need platform MeMed Key® to help healthcare providers distinguish between bacterial and viral infections. The technology has been cleared for both children and adults.

We’re proud to have been MeMed’s partner in this exciting journey. Our experienced, cross-functional project team’s ability to streamline the adjudication process, convert the data sets and deliver the submission packages efficiently and cost effectively, meeting all key deadlines, contributed to MeMed’s success in reaching this critical milestone.