The pharmaceutical drugs manufacturers are moving towards adaptive design in clinical trial as per the U.S.FDA guidance. The adaptive trial design is giving great benefit than a traditional drug trial design through the new drug approval from the pipeline to the patients. The meaning of to accept adaptive trial design is to make clinical trial more efficient by allowing changes in clinical trial. Adaptive trial design allows researchers modification in the clinical trial and/or statistical procedure of the clinical trial after initiation of clinical trial without harming trial validity and integrity. Traditional drug trials were conducted on a set of very strict rules without inflexibility.
Gottlieb thoughts about traditional v/s adaptive design
Gottlieb (2006) said in his speech before the FDA Conference on Adaptive Trial Design, traditional clinical trials are “highly empirical” in that new drugs are tested on general populations with common disease and observed by overall response rates. This design give knowledge about the drug that is effective for a known percentage of the population studied, but not for ineffective for others populations. Drug developers were testing a new cancer drug on patients which define the cancer anatomically, i .e. new drug tested on everybody with all tumor site like lung cancer, breast cancer colon cancer and looking for overall response of the drug. This traditional, highly empiric statistical method has had the central, and special, role in drug development. The empiric approach is rigorous and focused with inflexibility in side effects resulting in limiting innovation in the design and analysis of clinical trials do not predict responses. Under this study design physician we...
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I believe that the adaptive design approach to clinical drug trials is a leap forward in medicine research in term of less harm to the patients. Physicians will not blindly prescribe medicines based on population-wide responses. Drug companies will need to learn to navigate this new landscape, but it is apparent that the FDA is on-board with implementing an adaptive approach to drug trials. In both words and actions, the FDA is laying the groundwork for a future where drug trials may become therapeutic and ethical rather than purely scientific. Adaptive designs could have other benefits. An adaptive design can also be more effective than standard designs at identifying 'the right dose ' with a smaller sample size. Another advantage is that many more doses can be considered in an adaptive design, even though some may be little used or even never used.
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