Participation of the elderly, women, and minorities in pivotal trials supporting 2011–2013 U.S. Food and Drug Administration approvals

Table 4 Availability of at least one subgroup analysis for each indication associated with novel therapeutic agents approved by the U.S. Food and Drug Administration between 2011 and 2013

Subgroup analysis reported in medical or statistical review	All indications, n (%)	Indications which involve patients across subgroup,^a n (%)
Age	85/92 (92.4 %)	65/70 (92.9 %)
Sex	80/92 (87.0 %)	76/84 (90.5 %)
Race	74/92 (80.4 %)	73/84 (86.9 %)
Ethnicity	21/92 (22.8 %)	n/a

^aIncludes only those indications for which the prevalence of the disease is evenly spread across patients of all ages, sexes, or races. Indications for which the prevalence in three key demographic subgroups (age ≥65 years, female sex, nonwhite race) was less than half that of the prevalence among other patients were excluded.

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