The Pharmaceutical Drug Manufacturers Are Moving Toward Adaptive Design

1579 Words Feb 25th, 2016 7 Pages
The pharmaceutical drug manufacturers are moving towards adaptive design in a clinical trial as per the U.S.FDA guidance. The adaptive trial design is giving greater 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 trials. Adaptive trial design allows researchers modification in the clinical trial and/or statistical procedure of the clinical trial after initiation of a clinical trial without harming trial’s 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 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 gives knowledge about the drug that is effective for a known percentage of the population studies, but not for ineffective for others populations. Drug developers were testing a new cancer drug on patients, which defined the cancer anatomically, i .e. new drug were tested on everybody with all tumor sites like lung cancer, breast cancer, colon cancer and looking for an overall response of the drug. This traditional, highly empirical statistical method has had the central,…
Open Document