From Informed Consent through Database Lock: An Interactive Clinical Trial Conducted Using the Internet
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Kristin 1. Eilenberg, BS e-Researchand Development,dilly, Eli Lilly and Company, Indianapolis, Indiana
Amy M. Hoover, RN, BSN Clinical Development Associate, Eli Lilly and Company, Indianapolis, Indiana
Michael 1. Rutherford, MS Quality Consultant. Eli Lilly and Company, Indianapolis. Indiana Catherine A. Melfi, PhD Senior Regulatory Research Scientist, Eli L i l y and Company, Indianapolis. Indiana and Adjunct Faculty Member at the Indiana University Department of Medicine, Indianapolis. Indiana
Stott Segal, MD Clinical Research Physician. Eli Lilly and Company, Indianapolis. Indiana
Key Words Online: World Wide Web: Internet: Clinical research design: Tadalafil Correspondence Address Kristin Eilenberg. Lilly Corporate Center. Eli Lilly and Company, Indianapolis, IN 46285 (e-mail: [email protected]). An abstract ofthis paper was presented at the DIA Workshop "E-Pharm: Enabling Clinical Research and Business in the Pharmaceutical Industry," October 21 -23, 2002. Philadelphia, PA.
'The trial and manuscript development were funded by Eli Lilly and Company and Lilly ICOS. LLC.
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From Informed Consent through Database Lock: An Interactive Clinical Trial Conducted Using the Internet* This paper describes an interactive clinical trial that utilized the World Wide Web and Internet technologies throughout the conduct of the trial from informed consent through database lock and study closure. We believe this is the first development and administration of an interactive clinical trial that utilized the Internet for trial execution while complying with regulations for clinical trials conducted under an Investigational New Drug application. A United States study of tadalafil, a phosphodiesterase-5 inhibitor used as an oral treatment of erectile dysfunction, was chosen to implement the interactiveclinical trial. The trial consistedof 83 enrolled patients who were randomly assigned
INTRODUCTION The Internet, a global "network of networks," is transforming global information management and communication. The proliferation of the Internet and Web browsers during the last decade has been a spectacular phenomenon affecting almost all areas of business, communication, and education (1).Today, those with access to the Web through desktop and handheld computers and phones can instantaneously check weather conditions and stock quotes, shop, participate in auctions, make reservations, and download books, music, and movies. The Internet likewise is beginning to transform healthcare. With a click on a Web page, healthcare consumers can access medical information, assess health risks, fill prescriptions, participate in disease management programs and online chat groups, and consult with physicians online (2,3).As of 2004,88% of American homes had access to the Internet (4). Furthermore, approximately 55% of American adults with Internet access have used the Internet for
to either tadalafil 20 mg or placebo for four weeks of treatment. The trial leveraged the Internet for the informed consentprocess, randomization, drug dispensing
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