pH Associates discuss the recent eyeforpharma article ” Diversity Dilemma”
While randomised clinical trials remain the gold standard for assessing drug safety and efficacy, it cannot be ignored that the clinical trial patient population remains a largely homogeneous one – composed generally of white males1.
Industry are increasingly acknowledging the need for ‘diversity-sensitive clinical evidence’, and real world evidence can certainly play its part in helping to plug these important knowledge gaps. Generally speaking, once a drug enters standard clinical practice (post-licence), it is often accessed by a far more diverse set of patients, compared to the ‘N=’ clinical trial patient group.
A shift in focus from the key clinical research performed at specialty care centers (where clinical trials tend to concentrate) pre-license, to research and data gathering in the wider real world setting post-license, may help to address these disparities and boost the evidence base for patients accessing new medicines, regardless of age, sex, ethnicity or socioeconomic status.
1.Diversity in Clinical and Biomedical Research: A Promise Yet to Be Fulfilled. Sam S. Oh et al. PLoS Med. 2015 Dec 15;12(12):e1001918