Data Management 101 for Drug Developers: A Peek Behind the Curtain. (PubMed, Clin Transl Sci)
For added color and context, the review includes real-world examples with RRx-001, a new molecular entity (NME) in Phase 3 and with fast-track status in head and neck cancer, and AdAPT-001, an oncolytic adenovirus armed with a transforming growth factor-beta (TGF-β) trap in a Phase 1/2 clinical trial with which the authors, as employees of the biopharmaceutical company, EpicentRx, are closely involved. An alphabetized glossary of key terms and acronyms used throughout this manuscript is also included for easy reference (See Table 1).