Original ArticleQuantifying the Magnitude and Cost of Collecting Extraneous Protocol DataGetz, Kenneth A. MBA; Stergiopoulos, Stella BA; Marlborough, Michelle BS; Whitehill, Jane BS; Curran, Marla PhD; Kaitin, Kenneth I. PhDAuthor Information 1Tufts Center for the Study of Drug Development, Tufts University, Boston, MA 2Medidata Solutions Worldwide, New York, NY 3Regeneron, Tarrytown, NY 4GlaxoSmithKline, King of Prussia, PA. Address for correspondence: Assistant Professor, Director of Sponsored Research Programs, Tufts Center for the Study of Drug Development, Tufts University, 75 Kneeland Street, Suite 1100, Boston, MA 02111. E-mail: [email protected] Supported in part by a grant from Medidata Solutions Worldwide, who also provided data from several of its proprietary electronic solutions, and developed the custom data capture tool used for this study. Tufts Center for the Study of Drug Development is funded in part by unrestricted grants from pharmaceutical and biotechnology firms, as well as from companies that provide related services to the industry. American Journal of Therapeutics: March/April 2015 - Volume 22 - Issue 2 - p 117-124 doi: 10.1097/MJT.0b013e31826fc4aa Buy Metrics Abstract Although most research professionals believe that protocol designs contain a growing number of unnecessary and redundant procedures generating unused data, incurring high cost, and jeopardizing study success, there are no published studies systematically examining this issue. Between November 2011 and May 2012, Tufts Center for the Study of Drug Development conducted a study among a working group of 15 pharmaceutical companies in which a total of 25,103 individual protocol procedures were evaluated and classified using clinical study reports and analysis plans. The results show that the typical later-stage protocol had an average of 7 objectives and 13 end points of which 53.8% are supplementary. One (24.7%) of every 4 procedures performed per phase-III protocol and 17.7% of all phase-II procedures per protocol were classified as “Noncore” in that they supported supplemental secondary, tertiary, and exploratory end points. For phase-III protocols, 23.6% of all procedures supported regulatory compliance requirements and 15.9% supported those for phase-II protocols. The study also found that on average, $1.7 million (18.5% of the total) is spent in direct costs to administer Noncore procedures per phase-III protocol and $0.3 million (13.1% of the total) in direct costs are spent on Noncore procedures for each phase-II protocol. Based on the results of this study, the total direct cost to perform Noncore procedures for all active annual phase-II and phase-III protocols is conservatively estimated at $3.7 billion annually, not including the indirect costs associated with collecting and managing Noncore procedure data and the ethical costs of exposing study volunteers to unnecessary risks associated with conducting extraneous procedures. Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved.