Challenges and Solutions for the Use of Remote Study Monitoring in a Transcontinental Project
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Drug Information J o u m l . Vol. 34. pp. 121-127, 2000 Printed in the USA. All rights reserved.
CHALLENGES AND SOLUTIONS FOR THE USE OF REMOTE STUDY MONITORING IN A TRANSCONTINENTAL PROJECT JOHA”
PROVE,PHD
Head, Remote Data Entry Europe & Overseas, Bayer Vital GmbH & Co. KG, Leverkusen, Germany
Remote study monitoring (RSM) rather than remote data entry has been employed by Bayer in Europe and overseas over the past four years. Despite the fact that starting with RSM certainly requires up-front investments, Bayer decided to apply RSM in the development of Phase 2 and Phase 3 of a new anti-infective. The submission was filed in less than three years and the drug (Avelox’) is on the market already. This paper focuses on the challenges that surfaced while running a f i l l development program in 36 countries and at 800 investigator sites all over the world. The pros and cons of running such a project in a wide range of countries, with different infrastructure and phone systems, languages, and sojiware experience at the investigator sites are discussed. The experience showed that the sofnvare package used was not necessarily the limiting factor when running studies with RSM. Solutions were found for the continuously incoming and burning challenges. The change in company culture required due to the closer cooperation between all parties involved in the clinical development of a new compound is addressed. Finally, recommendations for the introduction of RSM in a pharmaceutical company with criteria for the study selection and the proper preparation for the new technology are made. Key Words: Remote data entry; Electronic data capture; Remote study monitoring; Interna-
tional development; Avelox’
INTRODUCTION THE DEVELOPMENT TIMES for new drugs are continuously under evaluation with the goal of reducing the time from discovery to marketing. Several factors contribute to the duration of clinical development, one of them being the time to complete the clinical
Presented at the DIA Workshop “Electronic Data Capture: Technologies, Implications and Future Requirements,” November 16-17, 1998, Baltimore, Maryland. Reprint address: Dr. Johann Prove, Bayer Vital GmbH & Co.KG, Medical Department/RDE, Building D 162, 51368 Leverkusen, Germany.
trials required for a successful submission and approval. Activities related to the processing of a single ma1 can be broken down into several subprocesses, such as ‘time between protocol development and first patient enrolled’ or ‘time between institutional review board approval and first patient on database.’ One subprocess has been identified as taking a considerable amount of time in the entire process; the ‘time between last patient last visit to a clean database.’ For data management at Bayer, the time needed became a key performance indicator. Bayer introduced remote study monitoring as a tool to improve this criterion, in particular.
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Johann Prove
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BACKGROUND AND DEFINITIONS For RSM, Bayer used
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