Lilly Achieves Milestone in Completing Novel Internet-based Clinical Study on Experimental Treatment
Magellan Study Accelerates Clinical Trial Process
Wednesday, March 20, 2002
Eli Lilly and Company, in conjunction with Lilly ICOS LLC, today announced that it has completed the last patient visit for its first interactive clinical trial (iCT) referred to as "Magellan," which involves Internet-based data capture from patients accessing the system through their home computer. Developed in collaboration with 1747, Inc., a San Francisco company and one of the e.Lilly venture fund's early investments, Magellan's innovative online approach focuses on streamlining and integrating clinical processes to improve the investigator and patient experience. The Phase III clinical trial was designed to assess the safety and efficacy of Lilly ICOS' experimental compound for erectile dysfunction (ED), Cialis™ (tadalafil) in more than 80 patients at two U.S. clinical sites.
"We are very pleased with the conduct of our first iCT," said John Lechleiter, Ph.D., Lilly executive vice president, pharmaceutical products and corporate development and Lilly ICOS board member. "We believe that this forms the basis for an innovative approach to using the Internet for clinical trial research. The interactive technology of this trial exceeded our expectations, and we are moving forward with plans to apply this methodology to other clinical trials."
Magellan's processes include:
ability of clinical investigators to monitor patients' safety and track patients' input in real-time gathering informed consent electronically and testing the patient's understanding of the consent content with an online quiz randomization of patients while they are accessing the system from their home using the Internet electronic tracking, administration and accountability of study drug, including the shipping of study drug to the patient's home online capture of patient history, standardized efficacy surveys and patient diaries; use of electronic signatures in accordance to regulations; and collection of feedback and data from the patient and the study center about participation in this clinical trial the creation of a new safety-monitoring role, called the Central Safety Nurse, who under the direction of an investigator helps to ensure accuracy, completeness and consistency in patient adverse-event reporting and data collection.
Following an in-office visit by patients -- which includes a physical examination and laboratory tests -- and a formal enrollment in the study, the effectiveness of the patient's trial experience is based on personal evaluations. Using the Internet for iCTs can help to ensure quality of the data from the investigator site and patients, reduce costs associated with conducting a trial and help to increase the speed at which clinical data are made available to the company.
"This innovative, high-quality approach changes the clinical trial paradigm by leveraging new methods and technology to positively affect patient and investigator data capture and experience while participating in a clinical trial," said Alph Bingham, vice president eR&D, e.Lilly. "This new method integrates and streamlines the essential interaction points between the investigator and patient."
Last patient visit, data lock and site closeout visits were completed in 24 hours-a process that sometimes can take weeks. Lilly ICOS will submit the findings to the U.S. Food and Drug Administration (FDA).
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