Adaptive Clinical Trials
@article{Coffey2008AdaptiveCT, title={Adaptive Clinical Trials}, author={C. Coffey and John A. Kairalla}, journal={Drugs in R & D}, year={2008}, volume={9}, pages={229-242} }
Adaptive designs promise the flexibility to redesign clinical trials at interim stages. This flexibility would provide greater efficiency in drug development. However, despite this promise, many hesitate to implement such designs. Here we explore three possible reasons for the hesitation: (i) confusion with respect to the definition of an ‘adaptive design’ (ii) controversy surrounding the use of sample size re-estimation methods; and (iii) logistical barriers that must be overcome in order to… CONTINUE READING
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References
SHOWING 1-10 OF 96 REFERENCES
A regulatory view on adaptive/flexible clinical trial design.
- Computer Science, Medicine
- Biometrical journal. Biometrische Zeitschrift
- 2006
- 69
The role of internal pilot studies in increasing the efficiency of clinical trials.
- Mathematics, Medicine
- Statistics in medicine
- 1990
- 388
Continual reassessment method: a practical design for phase 1 clinical trials in cancer.
- Computer Science, Medicine
- Biometrics
- 1990
- 1,196
Adaptive Designs in Clinical Drug Development—An Executive Summary of the PhRMA Working Group
- Psychology, Medicine
- Journal of biopharmaceutical statistics
- 2006
- 291
- PDF
Mid-trial design reviews for sequential clinical trials.
- Computer Science, Medicine
- Statistics in medicine
- 2001
- 46
Combining different phases in the development of medical treatments within a single trial.
- Computer Science, Medicine
- Statistics in medicine
- 1999
- 244
Re-evaluating design specifications of longitudinal clinical trials without unblinding when the key response is rate of change.
- Computer Science, Medicine
- Statistics in medicine
- 1995
- 31