CARER Group

Kay Olmstead, the co-founder of CARER Group will present an interactive session on Clinical Trial Diversity during the Outsourcing in Clinical Trials on September 24th in La Jolla, CA. Please join us. #clinicaltrialdiversity #healthequity

Way to go Sara Horton, MD! #TrailBlazer

CARER Group's Clinical Diversity Score Card has been published on Journal of Clinical Oncology Volume?42,?Number?16_suppl. https://lnkd.in/g5P6idg9 #clinicaltrialdiversity William Fitzsimmons, Sara Horton, MD, Stanley T. Lewis, MD, MPH, Chris Komelasky, Elizabeth Fassberg

Join us on?Thursday, September 19th at 12pm ET?as CARER Group's William Fitzsimmons presents #clinicaltrialdiversity at the Roivant Social Ventures?virtual conference "Increasing Impact: Leveraging Data to Drive Healthcare Access and Advancement."?This on-line event we will explore the power that data and representation hold in driving forward healthcare access and advancement. Register for this free event here: https://lnkd.in/gAEyc--C

Voranigo, an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor indicated for the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma was approved by the FDA in August 2024. These are rare brain tumors.?The overall Grade is C with good representation of females (Grade A) and poor representation of those 65 yo and older (Grade D).?Of note the FDA made the following comment in their review.?The FDA PMC/PMR checklist for trial diversity for Voranigo indicated the need for PMC/PMR. FDA review " The distribution of race was generally similar between arms and generally representative of the United States population; Black patients were likely under-represented, though there is a slight White predominance for this disease. Of the overall study population, only 3 Black/African American patients were enrolled. The distribution likely underrepresents the incidence of IDH-mutant Grade 2 glioma in this group and possibly other racial and ethnic minority groups. Despite these limitations, and given the targeted mechanism of vorasidenib, FDA agrees that the submitted data is supportive of the proposed indication for the US population.??"

Leqselvi,?a Janus kinase (JAK) inhibitor indicated for the treatment of adults with severe alopecia areata (a common autoimmune disease causing sudden hair loss on the scalp, face and sometimes other areas of the the body) was approved by the FDA in July, 2024. The overall Grade is C. There is poor representation of Hispanic ethnicity (D Grade). Also the pivotal trials excluded participants over 65 years of age.?

Piasky, a complement C5 inhibitor indicated for the treatment of adult and pediatric patients 13 years and older with paroxysmal nocturnal hemoglobinuria (PNH) was approved by the FDA in June, 2024.?The overall grade is C with poor Black and Hispanic representation in the trial (both D grade).?There was no enrollment in the US and 2/3 of the enrollment was from Asia therefore the Asian representation was good (B grade).??

Ohtuvayre, a phosphodiesterase 3 (PDE3) inhibitor and phosphodiesterase 4 (PDE4) inhibitor indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients by oral inhalation was approved by the FDA in June 2024. The overall Grade is B with very good representation of Elderly, >65yo.?(A grade).?

CTD scorecard for Sofdra, a topical anticholinergic indicated for the treatment of primary axillary hyperhidrosis (excessive underarm sweating) in adults and pediatric patients 9 years of age and older is issued below. The overall grade is B with excellent representation of Black and Hispanic participants (both A grade) and poor representation of Asian participants (F Grade).??

Iqirvo, a peroxisome proliferator-activated receptor (PPAR) agonist indicated for the treatment of primary biliary cholangitis (PBC) was approved in June. The overall grade is C with good representation for Females (B grade), and poor representation for Elderly (D grade).?Of note the Hispanic representation was not reported and the FDA review states the following: "In a response to IR dated March 29, 2024, the Applicant stated that ethnicity information was not collected in this study; the Applicant provided additional context stating: “There were 7 subjects enrolled in Argentina (4 on elafibranor and 3 on placebo); 16 subjects enrolled in Chile (12 on elafibranor and 4 on placebo); and 11 subjects enrolled in Spain (7 on elafibranor and 4 on placebo). In addition, for one subject enrolled in the United States, and one subject enrolled in Canada, the site entered self-reported race as ‘other’ and the free text entered for those cases stated ‘Hispanic’ and ‘Mexican’, respectively.”?