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. 2022 Aug 1;5(8):e2227252.
doi: 10.1001/jamanetworkopen.2022.27252.

Participation of Lower and Upper Middle-Income Countries in Clinical Trials Led by High-Income Countries

Fidel Rubagumya  1   2   3 , Wilma M Hopman  4 , Bishal Gyawali  2   3   4 , Deborah Mukherji  5 , Nazik Hammad  3 , C S Pramesh  6 , Mykola Zubaryev  7 , Alexandru Eniu  8 , Audrey T Tsunoda  9 , Tezer Kutluk  10 , Ajay Aggarwal  11   12 , Richard Sullivan  11 , Christopher M Booth  2   3   4
Affiliations

Participation of Lower and Upper Middle-Income Countries in Clinical Trials Led by High-Income Countries

Fidel Rubagumya et al. JAMA Netw Open. .

Erratum in

  • Omission in Title.
    [No authors listed] [No authors listed] JAMA Netw Open. 2022 Sep 1;5(9):e2235554. doi: 10.1001/jamanetworkopen.2022.35554. JAMA Netw Open. 2022. PMID: 36125816 Free PMC article. No abstract available.

Abstract

Importance: Many randomized clinical trials (RCTs) led by high-income countries (HICs) now enroll patients from lower middle-income countries (LMICs) and upper middle-income countries (UMICs). Although enrolling diverse populations promotes research collaborations, there are issues regarding which countries participate in RCTs and how this participation may contribute to global research.

Objective: To describe which UMICs and LMICs participate in RCTs led by HICs.

Design, setting, and participants: A cross-sectional study of all oncology RCTs published globally during January 1, 2014, to December 31, 2017, was conducted. The study cohort was restricted to RCTs led by HICs that enrolled participants from LMICs and UMICs. Study analyses were conducted in November 1, 2021, to May 31, 2022.

Main outcomes and measures: A bibliometric approach (Web of Science 2007-2017) was used to explore whether RCT participation was proportional to other measures of cancer research activity. Participation in RCTs (ie, percentage of RCTs in the cohort in which each LMIC and UMIC participated) was compared with country-level cancer research bibliometric output (ie, percentage of total cancer research bibliometric output from the same group of countries that came from a specific LMIC and UMIC).

Results: Among the 636 HIC-led RCTs, 186 trials (29%) enrolled patients in LMICs (n = 84 trials involving 11 LMICs) and/or UMICs (n = 181 trials involving 26 UMICs). The most common participating LMICs were India (42 [50%]), Ukraine (39 [46%]), Philippines (23 [27%]), and Egypt (12 [14%]). The most common participating UMICs were Russia (115 [64%]), Brazil (94 [52%]), Romania (62 [34%]), China (56 [31%]), Mexico (56 [31%]), and South Africa (54 [30%]). Several LMICs are overrepresented in the cohort of RCTs based on proportional cancer research bibliometric output: Ukraine (46% of RCTs but 2% of cancer research bibliometric output), Philippines (27% RCTs, 1% output), and Georgia (8% RCTs, 0.2% output). Overrepresented UMICs include Russia (64% RCTs, 2% output), Romania (34% RCTs, 2% output), Mexico (31% RCTs, 2% output), and South Africa (30% RCTs, 1% output).

Conclusions and relevance: In this cross-sectional study, a substantial proportion of RCTs led by HICs enrolled patients in LMICs and UMICs. The LMICs and UMICs that participated in these trials did not match overall cancer bibliometric output as a surrogate for research ecosystem maturity. Reasons for this apparent discordance and how these data may inform future capacity-strengthening activities require further study.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Gyawali reported receiving consulting fees from Vivio Healthcare outside the submitted work. Dr Tsunoda reported receiving fees for educational lectures from Roche, GlaxoSmithKline, Ethicon, and Medtronic, and fees from AstraZeneca for educational lectures and advisory board participation outside the submitted work. No other disclosures were reported.

Figures

Figure.
Figure.. Country-Level Proportional Representation in Oncology RCTs Published From 2014 to 2017 Led by HICs for Selected LMICs and UMICs Shown Together With the Proportion of Total Bibliometric Output From 2007 to 2017 for Cancer Research
Representation of lower middle–income countries (n = 84 trials) (A) and higher middle–income countries (n = 181 trials) (B). Countries included participated in at least 5% of lower middle–income countries trials and at least 20% of upper middle–income countries trials. HICs indicates high-income countries; LMICs, lower middle-income countries; RCTs, randomized clinical trials; UMICs, upper middle-income countries.
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