Tutorial on Data Management

Author: Bryan Oronsky, MD, PhD on December 20, 2023


I work closely with a biostatistician—his name is Nacer Abrouk—whose favorite car, bar none, is a Porsche. A true loyalist, the only car that Nacer has owned as an adult is a Porsche. His current ride is one of the fastest with a top speed of 143 miles per hour—the all-electric Porsche Taycan.

Not a Porsche is the built-for-purpose drug development “vehicle” that Nacer and I share with 12 others to take us from where we are currently—in clinical trials with our lead small molecule, RRx-001 (nibrozetone) and our lead oncolytic adenovirus, AdAPT-001—to where we want to go—the finish line of FDA regulatory approval. Unlike the Taycan, which consumes electricity, the “fuel” that drug development runs on is data. It is quite literally data driven.

In a tutorial from Clinical and Translational Science (CTS) entitled “Data Management 101 for drug developers: A peek behind the curtain”, my coauthors and I review the essentials of clinical data management. This tutorial is mainly for those who are new to drug development and assumes only a passing familiarity with the terms and concepts that are introduced.

Hop in; we invite you to come along for the ride.


Photo credit: Shutterstock/Whitevector

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