Day: September 28, 2017

Of the 55,000 subjects who participated in cancer clinical trials between 2003 and 2016, only 6% were African-Americans, 5% were Asians, and 3% were Hispanics, creating an abysmal minority representation in the data that formed the basis of FDA approval. There are no legal ways for FDA to push sponsors to increase minority representation in … Read more

Last week at a conference on real world evidence (RWE) organized by the National Academy of Sciences in Washington DC, the FDA Commissioner, Dr. Gottlieb, and The CDER chief, Dr. Woodcock, emphasized the limitation of conventional clinical trials and the importance of RWE, promising new guidance documents and new regulatory paradigms to increase the use … Read more