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European Pharmaceutical Contractor
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The process of developing and testing a new drug is lengthy, risky and costly. Various efforts are underway to reduce approval times and lower these risks. Technologies and processes that can help to ensure and accelerate FDA approval have the highest ROI impact for the sponsors. Among these efforts is the development and use of electronic patient diaries.
This article is not about patient compliance or how electronic patient diaries improve such compliance; these issues have already been documented extensively. Instead, we will focus on the factors to consider when choosing the best electronic patient diary for a trial.
ResearchandMarkets.com estimates that 25 to 30 per cent of all clinical trials currently use diaries, whether paper or electronic, to collect patient self-reported data (1). In 2002, the same report estimated that the proportion of patient diaries that use electronic format was approximately three per cent. It also forecasts that 25 per cent of patient diaries used in clinical trials will be electronic-based by 2007. As a vendor, we agree with this prediction based on changes we have seen in the industry.
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