Dr. Keja joined IQVIA 16 years ago and now is Global Category Leader HEOR, HTA and Secondary Data, Real World-Evidence Solutions at IQVIA, drawing on deep expertise in market access, drug safety, health economics, secondary and primary data collection. His background includes four years as European head of pricing, reimbursement, health outcomes and market access consulting services at Quintiles and more than 13 years experience in the pharmaceutical industry, including senior-level international and global roles in sales management, strategic marketing, pricing and reimbursement and health economics. Dr Keja holds a PhD in Biophysics (Neurophysiology) from Vrije Universiteit in Amsterdam, a Masters in Medical Biology, and an undergraduate degree in Biology, both from Utrecht University. He was also visiting Professor in marketing management and access at the Institute of Health Policy & Management at Erasmus University for 10 years up to 2018.
The Quest for Representativeness and Generalizability: How to recruit the right patient phenotype in a trial?
After explaining driving factors behind the increased scrutiny of generalizability, we will transition into detailing some regulatory aspects of representativeness.
The next section will be more hands on and address topics like database selection, digital recruitment through the web or straight form the EMR.
We will conclude with two cases, including the recruitment of MDD patients with particular pattern of sleep.