Ignacio Atal1, Ludovic Trinquart2, Philippe Ravaud3, Raphaël Porcher4. 1. Centre d'Épidémiologie Clinique, Hôpital Hôtel-Dieu, Paris, France; Team METHODS, INSERM U1153, Paris, France; Faculté de Médecine, Université Paris Descartes, Paris, France. Electronic address: ignacio.atal-ext@aphp.fr. 2. Centre d'Épidémiologie Clinique, Hôpital Hôtel-Dieu, Paris, France; Team METHODS, INSERM U1153, Paris, France; Department of Epidemiology, Columbia University, Mailman School of Public Health, New York, NY, USA; School of Public Health, Boston University, MA, USA. 3. Centre d'Épidémiologie Clinique, Hôpital Hôtel-Dieu, Paris, France; Team METHODS, INSERM U1153, Paris, France; Faculté de Médecine, Université Paris Descartes, Paris, France; Department of Epidemiology, Columbia University, Mailman School of Public Health, New York, NY, USA. 4. Centre d'Épidémiologie Clinique, Hôpital Hôtel-Dieu, Paris, France; Team METHODS, INSERM U1153, Paris, France; Faculté de Médecine, Université Paris Descartes, Paris, France.
Abstract
BACKGROUND: Concerns exist as to whether the allocation of resources in clinical research is aligned with public health needs. We evaluated the alignment between the effort of clinical research through the conduct of randomized controlled trials (RCTs) and health needs measured as the burden of diseases for all regions and a broad range of diseases. METHODS: We grouped countries into seven regions and diseases into 27 groups. We mapped all RCTs initiated between 2006 and 2015 that were registered at the WHO International Clinical Trials Registry Platform to regions and diseases. The burden of diseases in 2005 was mapped as disability-adjusted life years (DALYs), based on the 2010 Global Burden of Diseases study. Within regions, we defined a research gap when the proportion of RCTs concerning a disease in the region was less than half the relative burden of the disease. RESULTS: We mapped 117,180 RCTs planning to enroll 42.6 million patients and 2,220 million DALYs. In high- versus non-high-income countries, 130.9 versus 6.9 RCTs per million DALYs were conducted. We did not identify any research gap in high-income countries. We identified research gaps for all other regions. In particular, for Sub-Saharan Africa, we identified research gaps for common infectious diseases (CID) and neonatal disorders (ND): 5.8% (95% uncertainty interval 4.7-6.9) and 2.0% (0.9-4.5) of RCTs in Sub-Saharan Africa concerned CID and ND, although these diseases represented 22.9% and 11.6% of the burden in the region, respectively. For South Asia, we identified research gaps for the same two groups of diseases. CONCLUSIONS: In non-high-income regions, the conduct of RCTs was misaligned with the distribution of major causes of burden, in particular infectious diseases and neonatal disorders in Sub-Saharan Africa and South Asia.
BACKGROUND: Concerns exist as to whether the allocation of resources in clinical research is aligned with public health needs. We evaluated the alignment between the effort of clinical research through the conduct of randomized controlled trials (RCTs) and health needs measured as the burden of diseases for all regions and a broad range of diseases. METHODS: We grouped countries into seven regions and diseases into 27 groups. We mapped all RCTs initiated between 2006 and 2015 that were registered at the WHO International Clinical Trials Registry Platform to regions and diseases. The burden of diseases in 2005 was mapped as disability-adjusted life years (DALYs), based on the 2010 Global Burden of Diseases study. Within regions, we defined a research gap when the proportion of RCTs concerning a disease in the region was less than half the relative burden of the disease. RESULTS: We mapped 117,180 RCTs planning to enroll 42.6 million patients and 2,220 million DALYs. In high- versus non-high-income countries, 130.9 versus 6.9 RCTs per million DALYs were conducted. We did not identify any research gap in high-income countries. We identified research gaps for all other regions. In particular, for Sub-Saharan Africa, we identified research gaps for common infectious diseases (CID) and neonatal disorders (ND): 5.8% (95% uncertainty interval 4.7-6.9) and 2.0% (0.9-4.5) of RCTs in Sub-Saharan Africa concerned CID and ND, although these diseases represented 22.9% and 11.6% of the burden in the region, respectively. For South Asia, we identified research gaps for the same two groups of diseases. CONCLUSIONS: In non-high-income regions, the conduct of RCTs was misaligned with the distribution of major causes of burden, in particular infectious diseases and neonatal disorders in Sub-Saharan Africa and South Asia.
Authors: Isabel Viguera-Guerra; Juan Ruano; Macarena Aguilar-Luque; Jesús Gay-Mimbrera; Ana Montilla; Jose Luis Fernández-Rueda; José Fernández-Chaichio; Juan Luis Sanz-Cabanillas; Pedro Jesús Gómez-Arias; Antonio Vélez García-Nieto; Francisco Gómez-Garcia; Beatriz Isla-Tejera Journal: PLoS One Date: 2019-02-27 Impact factor: 3.240
Authors: Ferrán Catalá-López; Rafael Aleixandre-Benavent; Lisa Caulley; Brian Hutton; Rafael Tabarés-Seisdedos; David Moher; Adolfo Alonso-Arroyo Journal: Trials Date: 2020-01-07 Impact factor: 2.279
Authors: Iain James Marshall; Veline L'Esperance; Rachel Marshall; James Thomas; Anna Noel-Storr; Frank Soboczenski; Benjamin Nye; Ani Nenkova; Byron C Wallace Journal: BMJ Glob Health Date: 2021-01
Authors: Jay J H Park; Rebecca F Grais; Monica Taljaard; Etheldreda Nakimuli-Mpungu; Fyezah Jehan; Jean B Nachega; Nathan Ford; Denis Xavier; Andre P Kengne; Per Ashorn; Maria Eugenia Socias; Zulfiqar A Bhutta; Edward J Mills Journal: Lancet Glob Health Date: 2021-05 Impact factor: 26.763