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Trends in Clinical Trials: Strategies to enhance clinical trial design
Datamonitor, Sep 2008, Pages: 110
Pharma is experiencing tough times, facing both economic and regulatory pressures, with increasing demands for improved safety data and comparative efficacy studies. Consequently, the duration, size, complexity and ultimately cost of clinical trials is on the increase, while simultaneously, the success of late-stage clinical trials is declining.
Scope
- Overview of current clinical trial trends
- Strategic recommendations on how to optimize clinical trial success
- Case study analysis of clinical trial and regulatory successes and failures
- Evaluation of why there are frequently differences in FDA and EMEA approval outcomes
Highlights of this title
In the increasingly competitive and cost-conscious pharmaceutical environment, it is important that pharma companies develop their pipeline products as quickly and cheaply as possible, while ensuring that they receive marketing approval as well as authorization from the relevant reimbursement agencies.
Approximately 58% of Phase III clinical trials are unsuccessful, with the primary cause for failure being the inability of the trial data to demonstrate efficacy of the tested product against placebo. However, this success rate can be improved by implementing a number of different strategies discussed herein.
Most drugs that apply for approval from the FDA and the EMEA are approved by both agencies. However, a minority of applications are approved by one agency and not the other, for reasons largely based upon the design of clinical trials that form part of the submission package. Find out how to maximize the chance of approval in both markets.
Key reasons to purchase this title
- Identify clinical trial trends in todays pharmaceutical market, and how this affects productivity and return on investment
- Understand how a wide range of strategies that can improve clinical trial design and outcome, and identify how these can best be implemented
- Gain insight into how to optimize the clinical trial process and increase the chance of clinical, and ultimately commercial success
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