Data Management 101 for drug developers: A peek behind the curtain.

In drug development a frequently used phrase is "data-driven". Just as high-test gas fuels a car, so drug development "runs on" high-quality data; hence, good data management practices, which involve case report form design, data entry, data capture, data validation, medical coding, database closure, and database locking, are critically important. This review covers the essentials of clinical data management (CDM) for the United States.

Retrospective analysis of the tolerability and activity of lacosamide in patients with brain tumors: clinical article.

Object: The object of this study was to determine the tolerability and activity of lacosamide in patients with brain tumors.

Methods: The authors reviewed the medical records at 5 US academic medical centers with tertiary brain tumor programs, seeking all patients in whom a primary brain tumor had been diagnosed and who were taking lacosamide.

Results: The authors identified 70 patients with primary brain tumors and reviewed seizure frequency and toxicities.