Director, Scientific Operations
Cardinal Health Real-World Evidence & Insights
Evolving Real World Data
Andrew Klink, PhD, MPH set out to change how the pharmaceutical industry uses real-world data (RWD) to make decisions and understand how medications work for patients outside of clinical trials.
To move the industry forward, Andrew helped Cardinal Health build its Real-World Evidence & Insights business just as the 21st Century Cures Act was implemented to bring innovations to patients more quickly and efficiently. The act placed increased focus on evaluating opportunities to use RWD to support regulatory decision-making. Because of Andrew’s contributions, Cardinal Health has a novel method for collecting and analyzing RWD. Unlike the more traditional method of simply gathering static data in electronic medical records, Cardinal Health developed robust research networks with providers and healthcare practices. This approach allows the team to not only collect RWD, but understand the detailed rationale behind treatment choices and patient outcomes. With more than 12 years of clinical and observational research experience in both academia and industry, Andrew is a leader in developing solutions to collect and use RWD to truly move the industry forward.
In 2021, Andrew and his team earned a $750,000 FDA grant to compare real-world evidence results against clinical trial results. As a result of the grant, the team is working with the FDA Oncology Center of Excellence to assess tumor response in the real-world setting—something that currently does not exist. The “Assessment of a Novel Methodology for Endpoints Assessing Response to Lymphoma Treatment in Real-World Studies,” will evaluate the accuracy of RWD for lymphoma tumor response specifically compared to randomized results in clinical care settings. The results of the 18-month long study could provide important insights to inform industry standards related to RWD study designs or study methodology.
As the project director, Andrew is responsible for designing the study, developing the study protocol, and disseminating study results and incorporating study results into research practices, placing him in a lead position in the industry as real-world evidence continues to advance patient care.