Demographic Representation in Clinical Trials for Transthyretin-Associated Cardiac Amyloidosis: A Systematic Review.

What was studied

This review looked at who joins clinical trials of a heart condition called ATTR-CM. It covered completed trials in the US. 16 trials met the entry rules. The review compared who enrolled with who would be expected. The expected mix was based on how common the disease is in each group. It also asked if reporting improved after an FDA rule in 2017.

What they found

Black participants fell below an adequacy score of 0.75 in all reviewed trial phases. This was not true for Asian or White participants. After 2017, more trials reported demographic data. The mix of races still differed from the expected mix before and after 2017. For Black participants, the enrollment fraction fell from 0.291 to 0.125 after 2017. Other minority groups showed similar falls.

What it means for patients

The authors say Black people are still underrepresented in these US trials. This holds despite better reporting after 2017. They say steps are urgently needed. These include community outreach, more varied trial sites, enrollment targets and sponsor accountability.

Why it is not certain yet

Only completed US trials with posted results were included. The expected mix was based on one registry study. The abstract does not say why enrollment was low. A review can only be as good as the studies in it.

Source

Demographic Representation in Clinical Trials for Transthyretin-Associated Cardiac Amyloidosis: A Systematic Review.

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