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Innovative Clinical Trial Design and Management: Trends, Success Stories and Impact upon R&D Budgets
Business Insights, May 2008, Pages: 170
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...
Key findings...
Major pharma companies are implementing adaptive trials to improve dose-finding in the Phase 2 setting. The use of adaptive clinical trials will increase across the industry over the next 2-3 years.
Adaptive clinical trial designs are more effective than traditional designs in cases where there is uncertainty surrounding the dose, effect size and variability, clinical endpoint or patient populations.
The planning and execution of adaptive designs is more complex than the traditional approach. Successful implementations require teams of statisticians, data managers, clinicians and drug supply and logistics managers to work together as early as possible.
Predictive biomarkers have been found to require detailed prospective analysis far earlier in the clinical development process, and with the same clarity as traditional drug approvals. Post-hoc correlations were previously thought to be good enough for identifying the biomarkers used to predict the patients most likely to respond well to a new treatment.
Regulatory authorities are supportive of adaptive trials, particularly in the Phase 2 setting. However, there are concerns over the confidentiality of data and companies have been asked to demonstrate that the parties involved in running the study will remain unaware of ongoing adaptations.
Key questions answered...
- How can adaptive trials improve the success rates of clinical drug projects?
- How are pharma companies implementing adaptive trials and what major hurdles can prevent such implementations?
- What is the position of the FDA and EMEA in regards to different types of adaptive trial?
- How can logistical and strategic planning be managed most effectively?
- Which companies are offering services to support adaptive clinical trials?
- Which companies are co-developing drugs and diagnostic products?
Key issues examined by this report...
- Adaptive trial implementations. The aim of adaptive trials is to improve the information value of clinical trials whilst maintaining their integrity and validity. The use of adaptive trials in the early phases of drug development should yield better information and lead to the earlier termination of unsuccessful compounds.
- Dose finding improvements. The availability of new Bayesian study designs that acknowledge prior information and allow for the testing of a wider range of doses has enabled more accurate dose-finding. This may have important consequences for the success of future Phase 3 clinical programs
- Seamless trial speed. Major pharma companies are interested in the prospect of combining drug development phases into ‘seamless trials’, with the potential to reduce the length of clinical development programs in the Phase 2b/3 setting
- Regulatory issues. Engaging with the FDA/EMEA during the protocol design stages of an adaptive trial is important, especially for studies intended for use in packages of pivotal clinical data. The EMEA’s current position on adaptive clinical trial design is summarized within a reflection paper published in October 2007, while draft FDA guidance is expected in 2008.
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