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- Uncategorized (21)
- 22. March 2010: Informed Cosent
- 22. February 2010: Data Capture Methods
- 8. February 2010: Costs and finances in clinical trials
- 27. January 2010: Clinical Trials: Need and Ways
- 25. January 2010: PROJECT MANAGEMENT
- 17. January 2010: Pharmacovigilance :
- 17. January 2010: Adaptive Clinical Trials
- 11. January 2010: How ICH-GCP differs from Indian GCP?
- 25. December 2009: An exclusive workshop on fundamentals of ICH-GCP and clinical research
- 17. December 2009: Top 5 Mistakes of RFP
Adaptive Clinical Trials
Clinical trial methodology that allows trial design modifications to be made after patients has been enrolled in a study, without compromising the scientific method and integrity of data.
It also Empowers sponsor to response to data collected during the Trial like Modifying sample size, dropping a treatment arm, balancing Treatment assignments using adaptive randomization or simply stopping a study early for success or failure.
Patients randomized to treatment arms based on the response to treatment of previous patients. Real-time safety & efficacy data incorporated into randomization strategy and Play-the-winner: Assignment of patients to treatment arms that resulted in fewer adverse events or better efficacy
Advantages:
Cost reduction: Stopping unsuccessful trials earlier, identifying successful trials sooner, dropping unnecessary treatment arms or determining effective dose regimes faster
Reduction in lead time between phases, especially II and III:
Reduced time to market
Improved patient safety
Reduced exposure to unsuccessful treatment arms
Increased access to effective treatment arms