Interview with Tobias Polak: Gleaning Real-World Data from Expanded Access Programs

June 24, 2022

Tobias Polak, a PhD student at Erasmus University and Director of Real-World Data (RWD) myTomorrows, recently published a paper in the British Journal of Clinical Pharmacology entitled, “Expanded Access as a source of real-world data: An overview of FDA and EMA approvals.” Polak spoke with The Evidence Base about the potential for expanded access programs (EAPs) as a source of RWD. EAPs allow patients with no remaining therapeutic options to access experimental therapies. In addition to providing patients with treatment options, EAPs allow researchers to collect comprehensive data on a drug that may not otherwise be collected.

According to Polak, “As EAPs by definition offer treatment outside of a clinical trial setting, it is almost intuitive to look at these programs to generate information on patients who could not participate in clinical trials. Patients in EAPs are less stringently selected compared to clinical trials and in that sense arguably are more ‘real-world’. There is sometimes a concern that clinical trials are so tightly controlled by stringent eligibility criteria determining who can enroll that they don’t necessarily represent the broader population of patients who will actually get the drug once it is made available to the public. RWD from EAPs can help address this potential gap by giving regulators and prescribing physicians more information about a drug in more diverse populations.”

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