We select products developed for broad use and evaluate diversity metrics, focusing on underrepresented populations - defined by age, sex, race, and ethnicity.
We determine a grade for each category, and then average them for an overall letter grade.
The grade is based on considerations of incidence/prevalence of the disease and/or condition and the percentage of the demographic group in the study population (see the chart below).
The overall grade is the average of all demographic subgroup grades.
Note: If data on a demographic subgroup is not reported (NR) then the grade will be an F if incidence of the disease being treated is increased, a D if incidence is similar, or a C if incidence is decreased.
To be certain scoring is fair, drug grades are not changed if the indication does not impact an underrepresented group. If trial diversity is necessary and the drug receives a D or F on any of the categories, even if the overall score adds up to an A, the drug will not receive an A. A’s are only assigned if the overall average score is 3.25 or greater AND if none of the sub-populations score a D or F.
Note: We recognize that certain groups, such as Native Americans, haven't been included - though not intentionally on our part. We were limited by the data available and chose to move forward regardless, in order to push the industry in a positive direction.
Color coding is also used to indicate whether the total number of individuals in the demographic subgroup who have been treated with the new molecular entity is fewer than 30 (red), 30-299 (yellow), or 300+ (green).
Note: the reason this is important is that N=30 is needed to detect a "very common" adverse reaction which occurs with an incidence of 10% or greater; N=300 is needed to detect a "common" adverse reaction which occurs with an incidence of 1% or greater.
