BAME patient representation in COVID-19 drug trials (version 2) [COVID-19}
Research type
Research Study
Full title
The representation of black, Asian, and minority ethnic patients in COVID-19 drug trials at Imperial College Healthcare NHS Trust
IRAS ID
285334
Contact name
Graham Cooke
Contact email
Sponsor organisation
Imperial College London
Clinicaltrials.gov Identifier
ISRCTN12345678 , ISRCTN ; NCT12345678 , NCT
Duration of Study in the UK
0 years, 1 months, 3 days
Research summary
A quantitative retrospective analysis of the representation of black, Asian, and minority ethnic (BAME) patients in COVID-19 drug trials at Imperial College Healthcare NHS Trust (ICHT), with comparison to the representation of BAME individuals within the COVID-19 inpatient cohort at ICHT.\nA qualitative and quantitative understanding of factors influencing the inclusion of BAME individuals in COVID-19 drug trials based on trial screening logs. [Study relying on COPI notice]
Summary of Results
An historical under-representation of BAME patients in medical research prompted concerns that COVID-19 studies were suffering from the same pitfall.
We conducted a retrospective analysis of the ethnicity of inpatients enrolled onto the six COVID-19 interventional treatment trials at Imperial College Healthcare NHS Trust.
Of the total 179 patients, 61 (34%) were BAME, 80 (45%) were white and for 38 (21%), ethnicity was unknown. Of the 83 patients enrolled into Recovery, 24 (29%) were BAME, 40 (48%) were white and for 19 (23%), ethnicity was unknown.
To understand if BAME representation within the trials was reflective of the total cohort of inpatients with COVID-19, we consulted the best available standard of comparison: a retrospective cohort study of all patients hospitalised with confirmed SARS-CoV-2 infection at ICHT between February 25 and April 5, 2020. Of the 520 patients in this cohort, 209 (40%) were BAME, 196 (38%) were white, and for 115 (22%) ethnicity was unknown.
Of the total 179 patients, 61 (34%) were BAME, 80 (45%) were white and for 38 (21%), ethnicity was unknown. Of the 83 patients enrolled into Recovery, 24 (29%) were BAME, 40 (48%) were white and for 19 (23%), ethnicity was unknown.
There was no statistically significant difference between the proportion of BAME patients across all trials compared to the total inpatient cohort (chi square test, p = 0.089). However, there was a statistically significant difference between the proportion of BAME patients in the Recovery trial compared to the total inpatient cohort (p = 0.036).REC name
East Midlands - Derby Research Ethics Committee
REC reference
20/EM/0177
Date of REC Opinion
2 Jul 2020
REC opinion
Favourable Opinion