An Essay by Susan Ellenberg from the University of Pennsylvania describes alternative approaches to the evaluation of clinical trials, with the objectives both of preventing undue risks to participants and protecting the integrity of data. Writing in this week's PLoS Medicine, the author outlines the importance of methods for ensuring independence of those involved in analysis of interim data, and for ensuring that early stopping guidelines are clearly laid out before a trial starts.
However, the author emphasises that issues around liability for individuals who provide these functions are currently unclear, and concludes: "DMCs [data monitoring committees] have become expected components of many clinical trials, and provide an important oversight function".
Funding: No specific funding was received for writing this article.
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. She does not believe any of these represent competing interests but declare them for completeness.
Citation: Ellenberg SS (2012) Protecting Clinical Trial Participants and Protecting Data Integrity: Are We Meeting the Challenges? PLoS Med 9(6): e1001234. doi:10.1371/journal.pmed.1001234
CONTACT:
Susan Ellenberg
Perelman School of Medicine at the University of Pennsylvania
Philadelphia
Pennsylvania
United States of America
sellenbe@upenn.edu
Journal
PLoS Medicine