With Real World Data, MediMergent Shares the Voice of the Patient

By Alex Keown
April 17, 2023

Real-world data has become increasingly important in life sciences research. Bruce Garett, chief operating officer of Rockville-based MediMergent calls it the “other arm of research.”

Collecting these data is at mission of MediMergent, a real-world data collection and analytics company. Working with clinical trial partners, MediMergent digs into the behavioral data of a patient in order to glean an understanding of a drug’s impact beyond efficacy results. Despite their importance in the process of drug development, Garrett said patients are the most underutilized resource in healthcare.

“Real-world data is the missing piece. It’s not just a flash-in-the-pan idea. It’s the reality of how you follow a patient throughout the course of treatment,” Garrett said.  He added that real-world data provides a broader, more realistic view of how well a medicine works in patients.

Garett explained that clinical trials often exclude essential bits of information, such as behavioral and attitudinal data, or other social determinants of health. As an example, Garrett recalled a clinical trial evaluating an experimental anticoagulant. The researchers overseeing the study were dutiful in collecting the data related to the administration of the test drug. However, they failed to consider patient behavior, such as the taking of aspirin during the study.

Aspirin is often used as a blood thinner by people as a measure to mitigate cardiovascular disease risks. Combined with an anticoagulant drug, the use of aspirin increases the risks of bleeding concerns in patients.

An examination of trial data did not reveal whether or not the use of aspirin was discussed with patients before beginning the study. Garrett said 38% of patients revealed they took aspirin during the trial when directly asked. He said it is critical to talk with patients and ask these kinds of questions. Doing so provides what Garrett and MediMergent calls “the voice of the patient.”

The patient’s voice remains the most underutilized resource in healthcare, Garrett said. Clinical trials have typically ignored the voice of the people when conducting research. That’s something MediMergent aims to address through its collaborations.

“We connect the voice of the patient through surveys. We ask open-ended questions that will provide us with as much information as possible. The goal is to try and understand how they (the patients) really feel, how the medicines are making them feel. The drug may be doing its job but if they are so tired they can’t get out of bed for three days, we need to know that,” said Garrett, a nephrologist by training. “The patient is the primary source for their own answers, it’s more direct and more efficient.”

MediMergent most recently participated in a real-world data-focused study addressing the impact of COVID-19 on cancer patients. The study, conducted in partnership with AON, was sparked by the death of former U.S. Secretary of State Gen. Colin Powell, a cancer patient who died from COVID-19-related complications. Powell had both multiple myeloma and Parkinson’s disease. Although he was vaccinated against COVID-19, his body was unable to generate the appropriate levels of antibodies against the virus due to his compromised immune system.

AON and MediMergent partnered on the EIMPRIS (Engaging Immuno-Protection Intervention Study) that was focused on the prevention of symptomatic SARS-CoV-2 infection in cancer patients. MediMergent applied its real-world data expertise to efficiently and economically collect, track and analyze high-quality patient-related data, Garrett said. Using the patient perspective allows for medical professionals to more accurately meet patients’ needs, he added.

The EIMPRIS trial, which was assessing a monoclonal antibody in immunocompromised patients as a prophylaxis against COVID-19 was halted by the FDA after the regulatory agency determined the drug was no longer effective against the most common strain of the SARS-CoV-2 virus. Before the study was halted, Garrett said MediMergent saw a patient response rate of nearly 90% to its surveys gleaning real world data.

“Patients have a vested interest in the responses they deliver. It means something to them,” he said.

With interest somewhat waning in COVID-19 research, Garrett said MediMergent will now turn its attention to the efficacy of different vaccines in patients with immune systems compromised by cancer. He suggested the company will examine vaccines for pneumonia and respiratory syncytial virus in these patients. Both disease indications disproportionately impact patients over the age of 60, and many of those people have been diagnosed with cancer.