Cardinal Health’s strategy to collect research-grade real-world data has been recognized in the most recent innovation issue of PM360, an industry-leading publication whose readership includes marketing decision makers in the pharmaceutical, biotech, diagnostics and medical device industries.
Each year, PM360 honors the most innovative companies, products, services and strategies from the life sciences industry; this year, the publication has recognized Cardinal Health’s Real World Evidence & Insights team (part of Cardinal Health Specialty Solutions) for its strategic approach to collecting regulatory-grade real-world data (RWD), which may result in faster, less expensive and more accurate data for regulatory decision-making, including the expansion of indications for currently approved drugs.
“As a practicing oncologist, I saw firsthand how clinical trial data did not always work for patients in the real world, because, though the information derived from this research was statistically significant, the patient population in the clinical trial often didn’t match the patient population I was treating, meaning the data was clinically incomplete,” said Bruce Feinberg, D.O., Chief Medical Officer of Cardinal Health Specialty Solutions.
As the world shifts to personalized medicines, healthcare experts are pointing to several issues with typical clinical trials, known as randomized clinical trials (RCTs). These clinical trials lack diversity, study generally healthier patients, and are expensive to conduct, both in time and dollars. As a result of these issues, there is a rapidly growing interest among stakeholders throughout the healthcare community in harnessing real-world data, including the data already collected from health information technology software – like electronic medical records, billing data and even fitness apps – to use for further scientific advancements.
One of the most promising uses for this type of RWD is that it can be analyzed to gain product approval from the U.S. Food and Drug Administration (FDA). Though RWD has been used in the past for other safety purposes like adverse effects, the FDA has been using RWD for regulatory submissions only since 2017. Researchers believe the use of this information for approval could both decrease the amount of time (and cost) required for product development, and provide an avenue for research with a more diverse set of patients compared to clinical trials. However, RWD traditionally lacks the research-grade data the FDA and other agencies must have for scientific approval.
As part of its strategy, the Cardinal Health Real World Evidence & Insights team, in partnership with the Regulatory Sciences team (which has supported more than 500 product approvals worldwide), has developed two types of innovative research networks that collect regulatory-grade RWD. Earlier this year, the FDA recently awarded Cardinal Health a grant to use these networks to compare RWD results to clinical trial results as a first step in developing a standardized methodology for RWD collection.
With these custom-made research networks, Cardinal Health’s team of epidemiologists and researchers can directly involve a more diverse set of patients and their healthcare providers in the data collection process. This process can include tactics like patient-reported outcomes and manual chart reviews conducted by study patients’ healthcare providers, and ultimately enable the team to provide a more wholistic view of the results for regulatory approval for pharmaceutical manufacturers.
“In order to truly transform the patient experience, we must improve the entire healthcare journey – starting with the development and regulatory submission stages. Real-world data allows us to advance patient care by providing quicker access to safer therapies, but only if the data we use can hold up to scientific rigor,” said Eli Phillips, Jr., PharmD, JD, vice president of Regulatory Sciences and Insights & Engagement at Cardinal Health. “I’m proud to lead a team of innovators who work tirelessly to make the healthcare journey equal for all, and that PM360 has recognized this important work.”
Read PM360’s article here.