188 CHAPTER 9 Acknowledging that creating diversity between RCTs, involving consultation between pharmaceutical companies and regulatory authorities to avoid testing medication (with a similar mechanism of action) in the same population, is idealistic and that not all medicines have the same mechanism of action, a more realistic solution to the reversal of the ‘inverse research law’ should be considered. It would be more feasible to better reflect relevant populations when allocating research funds. In addition, regulatory authorities, such as the European Medicines Agency (EMA) and the Food and Drug Administration (FDA), could play an important role in stimulating RCTs involving adequate numbers of clinically relevant populations. These authorities have taken first steps by developing regulations and guidelines on diversity in trials on medicinal products,47,48 but these regulations could be more stringent. Pharmaceutical companies could be obliged by these authorities to adequately address diversity to ensure that study populations in RCTs reflect the entire relevant patient population in society. For example, they could require that registration and market access of new medication is conditional on adequate inclusion in RCTs of underserved populations, such as frail elderly. In addition, marketing medication in populations that have not been adequately studied could be prohibited. Similar obligations related to gender have led to an increase in the number of women included in RCTs. Fourth, and perhaps even the most important point of action in reversing the ‘inverse research law’, is taking responsibility by researchers themselves to ensure that study populations in RCTs reflect the entire relevant patient population in society. Change starts with each individual: a drop in the ocean may seem small, but if enough drops fall, it creates a wave of change. Moreover, as exemplified by the FRAIL-AF RCT, it is worthwhile and rewarding to create such a wave using a team science approach and it ultimately impacts clinical practice.
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