Abstract
The costs associated with developing drugs have risen dramatically over the
past decade and fewer drugs are obtaining regulatory approval. The
pharmaceutical industry is continually exploring new ways of improving drug
developments and one area of focus is adaptive clinical trial designs. These
innovative clinical trial designs use accumulating data to guide potential
modifications to the study as it progresses, without undermining the validity
and integrity of the trial. The advantages of such designs include the reduced
length and cost of clinical trials, lower patient numbers and the ability to
stop a trial early where a drug has not shown efficacy. ' Innovative Clinical
Trial Design and Management' is a new report published by Business Insights
that explores the major types of adaptive design and their role in
dose-finding. The report investigates seamless Phase 2/3 trials and adaptive
trials in pharmacogenomics, assesses the logistical implications of adaptive
trial implementations and reviews the current regulatory standpoints of the
FDA and EMEA. Detailed case studies of recent adaptive clinical trials are
provided and the companies offering statistical expertise in this area are
profiled. This report also includes a breakdown of the potential cost and time
savings that innovative trial designs can offer throughout the clinical
development process. Use detailed case studies to explore recent adaptive
trial implementations, identify the companies pioneering and supporting
innovative designs and understand the most effective planning and logistics
strategies.
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