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Essay

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Protecting Clinical Trial Participants and Protecting Data Integrity: Are We Meeting the Challenges?

  • Susan S. Ellenberg mail

    sellenbe@upenn.edu

    Affiliation: Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, United States of America

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  • Published: June 12, 2012
  • DOI: 10.1371/journal.pmed.1001234

About the Author

Susan S. Ellenberg
Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, United States of America

Corresponding Author

Email: sellenbe@upenn.edu

Competing Interests

SE currently serves on 1 industry DMC (BMS) and 2 DSMBs for NIH-funded studies. SE also gets 5% of her salary via a contract to Penn from Pfizer to support statistical leadership on a study funded by Pfizer but designed and carried out by investigators independently of the company. Other companies from which SE has received fees for consulting or lecturing in the past 5 years: Ariad Pharmaceuticals; Shire Pharmaceuticals; Amgen; MGI; Novovax; Lux Bio; GPC Biotech; Astra-Zeneca; Merck; Genentech; J&J; Millenium; Onyx; Tengion; Tarsa; Allergan; and Curagen. SE has also done consulting for a legal firm handling pharmaceutical-related litigation. Most of these except for the data monitoring committees were one-time engagements, either to lecture at an internal scientific meeting or to participate in a mock advisory committee meeting. I do not believe any of these represent competing interests but declare them for completeness.

Author Contributions

Wrote the first draft of the manuscript: SE. Contributed to the writing of the manuscript: SE. ICMJE criteria for authorship read and met: SE. Agree with manuscript results and conclusions: SE.