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 interactive clinical trial. The trial consisted of 83 enrolled patients who were randomly assigned to either tadalafil 20 mg or placebo for four weeks of treatment. The trial leveraged the Internet for the informed consent process, randomization, drug dispensing and accountability, safety monitoring, in-home data collection of patientbased eficacy measures, and database lock. The efficacy data resembled traditional tadalafil clinical trial data; the adverse events incidence, how-eve6 was lower than anticipated. In a post-study survey, 77% of patients with traditional clinical trial experience indicated that the interactive clinical trial was better than a traditional trial. The success of this interactive clinical trial represents a new direction for regulatory-compliant clinical research powered by the Internet.
A microcomputer-controlled data acquisition and processing system, developed to carry out a variety of pulsed-laser spectroscopic experiments, is described. The hardware consists of largely off-the-shelf spectroscopic instrumentation in conjunction with an IBM personal computer. Versatile software with interactive graphics has been written with the use of Turbo BASIC. The software and hardware components are discussed in detail. As an example of the system performance, the LIF spectrum of S2O has been acquired with the use of an Nd:YAG pumped dye laser as the excitation source. Examples of interactive screen displays and a publication-quality spectrum are presented.
The health care reform movement in the USA and increased
requirements by regulatory agencies continue to have a major impact on the pharmaceutical industry and the laboratory. Laboratory management is expected to improve effciency by providing more analytical results at a lower cost, increasing customer service, reducing cycle time, while ensuring accurate results and more effective use of their staff. To achieve these expectations, many laboratories are using robotics and automated work stations. Establishing automated systems presents many challenges for
laboratory management, including project and hardware selection, budget justification, implementation, validation, training, and support. To address these management challenges, the rationale for project selection and implementation, the obstacles encountered, project outcome, and learning points for several automated systems recently implemented in the Quality Control Laboratories at Eli Lilly are presented.
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