Why are emerging countries popular for clinical research?

BACKGROUND: The business of clinical research has changed in the past two decades, shifting from industrialised Western countries to so-called emerging markets such as Eastern Europe, Latin America and Africa. An appraisal of the trends could identify associated factors that may have implications for the local populations and their endemic diseases. OBJECTIVES: To identify potential reasons why emerging countries have become attractive places for international sponsors to conduct their clinical trials. METHODS: Using ClinicalTrials.gov, the Pan African Clinical Trials Registry, the National Health Research Database and the Nigeria Clinical Trials Registry, trend data on clinical research development were determined for two emerging African markets, Nigeria and South Africa (SA), from 2010 to 2018. Also, health data on the two countries from the fact sheets of health statistics of the World Health Organization were compared, as well as regulatory and ethical conditions. Available data were analysed using descriptive statistics and trend analysis. RESULTS: The impact of globalisation is evident from the upward trend in clinical trials in SA before 2010, and the clear downward trend thereafter. One reason for this change could be the alignment of SA's regulatory and ethical frameworks with the Western world. In contrast, the upward trend is only just beginning in Nigeria, with the introduction of ethical/regulatory frameworks, and supportive institutions making the business of clinical research more attractive on an international level. Although the number of international and local sponsors increased in Nigeria from 2010 to 2018, only the latter increased in SA, with the former decreasing over the same period. Overall, there is a mismatch between country-specific diseases and the drugs being tested, to the extent that leprosy, which is endemic in Nigeria, and tuberculosis in SA were not in the list of top 10 study areas in either country. CONCLUSIONS: The globalisation trend is evident in the clinical trials business, but cannot be generalised to all emerging countries. Timing and intensity vary from country to country relative to factors that advance the existing profit-orientated business models of the sponsors. Furthermore, various diseases have been localised, which entails a diversely increasing need for research.

Neglected tropical diseases in Brazil: lack of correlation between disease burden, research funding and output.

OBJECTIVES: To assess the correlation between the burden of seven priority neglected tropical diseases (NTDs) included in the Brazilian National Agenda of Priorities in Health Research - tuberculosis, Chagas disease, leprosy, malaria, leishmaniasis, dengue and schistosomiasis - and their respective research funding and output. METHODS: This retrospective review obtained data on disease burden from the Global Burden of Disease Study and funding data from open access sources. Publications were retrieved from Scopus and SciELO, and characterised according to the type of research conducted. Correlation between funding, research output and burden was assessed by comparing the 'expected' and 'observed' values for funding and publications relative to the proportional burden for each disease. RESULTS: There was an emphasis in basic biomedical research (average 30% of publications) and a shortage of health policy and systems (average 7%) and social sciences research (average 3%). Research output and funding were poorly correlated with disease burden. Tuberculosis, Chagas disease and schistosomiasis accounted for more than 75% of total NTD-related DALYs, but accounted for only 34% of publications. Leprosy, leishmaniasis and malaria, together, received 49% of NTD-related funding despite being responsible for only 9% of DALYs. CONCLUSIONS: The analysis evidenced a lack of correlation between disease burden, research output and government funding for priority NTDs in Brazil. Our findings highlight the importance of monitoring health needs, research investments and outputs to inform policy and optimise the uptake of evidence for action, particularly in developing countries, where resources are scarce and the research capacity is limited. The results contribute to health policy by highlighting the need for improving coordination of scientific activities and public health needs for effective impact.

OBJECTIFS: Evaluer la corrélation entre la charge de sept maladies tropicales négligées (MTN) prioritaires incluses dans le programme national brésilien des priorités en matière de recherche en santé - tuberculose, maladie de Chagas, lèpre, paludisme, leishmaniose, dengue et schistosomiase - et leurs financements de recherche respectifs et les résultats. MÉTHODES: Cette revue rétrospective a obtenu des données sur la charge de morbidité de l'étude sur la Charge Globale des Maladies et des données de financement provenant de sources en accès publique. Les publications ont été extraites de Scopus et SciELO et caractérisées selon le type de recherche menée. La corrélation entre le financement, les résultats de la recherche et la charge a été évaluée en comparant les valeurs "attendues" et "observées" pour le financement et les publications par rapport à la charge proportionnel de chaque maladie. RÉSULTATS: L'accent a été mis sur la recherche biomédicale fondamentale (en moyenne 30% des publications) et une pénurie de politiques et de systèmes de santé (en moyenne 7%) et de recherche en sciences sociales (en moyenne 3%). Les résultats et le financement de la recherche étaient mal associés à la charge de morbidité. La tuberculose, la maladie de Chagas et la schistosomiase représentaient plus de 75% du total des EVCI, mais ne représentaient que 34% des publications. La lèpre, la leishmaniose et le paludisme, ensemble, ont reçu 49% des financements liés aux MTN alors qu'ils n'étaient responsables que de 9% des EVCI. CONCLUSIONS: L'analyse a mis en évidence une absence de corrélation entre la charge de morbidité, le résultat de la recherche et le financement de la plupart des MTN. Nos résultats soulignent l'importance du suivi des besoins en matière de santé, des investissements dans la recherche et des résultats pour éclairer les politiques et optimiser l'utilisation des données pour l'action, en particulier dans les pays en développement, où les ressources sont rares et la capacité de recherche est limitée. Les résultats contribuent à la politique de santé en soulignant la nécessité d'améliorer la coordination et la planification stratégique des activités scientifiques pour un impact efficace.

Comparing cutaneous research funded by the US National Institutes of Health (NIH) with the US skin disease burden.

BACKGROUND: Disease burden should be an important component for guiding research funding. OBJECTIVE: We sought to examine the relationship between dermatologic research funded from 2012 to 2013 by the National Institutes of Health (NIH) and US skin disease burden as measured by disability-adjusted life years in the Global Burden of Disease 2010 study. METHODS: A cross-sectional analysis was independently performed by 2 researchers who matched projects from the 2012 to 2013 NIH Research Portfolio Online Reporting Tools with 15 skin conditions and their respective disability-adjusted life years from Global Burden of Disease 2010. RESULTS: The NIH funded 1108 projects spanning the 15 skin conditions. Melanoma received almost half of the total skin condition budget (49.5%). Melanoma, nonmelanoma skin cancer, and leprosy were funded above what would be suggested by their disease burden, whereas dermatitis, acne vulgaris, pruritus, urticaria, decubitus ulcer, fungal skin diseases, alopecia areata, cellulitis, and scabies appeared underfunded. Bacterial skin diseases, viral skin diseases, and psoriasis were well matched with disease burden. LIMITATIONS: Disease burden is one of many factors that may be used to guide priority-setting decisions. CONCLUSION: Skin disease burden measured by disability-adjusted life year metrics partially correlates with NIH funding prioritization. Comparing US disease burden with NIH funding suggests possible underfunded and overfunded skin diseases.

Comparing cutaneous research funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases with 2010 Global Burden of Disease results.

IMPORTANCE: Disease burden data helps guide research prioritization. OBJECTIVE: To determine the extent to which grants issued by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) reflect disease burden, measured by disability-adjusted life years (DALYs) from Global Burden of Disease (GBD) 2010 project. DESIGN: Two investigators independently assessed 15 skin conditions studied by GBD 2010 in the NIAMS database for grants issued in 2013. The 15 skin diseases were matched to their respective DALYs from GBD 2010. SETTING: The United States NIAMS database and GBD 2010 skin condition disability data. MAIN OUTCOME(S) AND MEASURE(S): Relationship of NIAMS grant database topic funding with percent total GBD 2010 DALY and DALY rank for 15 skin conditions. RESULTS: During fiscal year 2013, 1,443 NIAMS grants were issued at a total value of $424 million. Of these grants, 17.7% covered skin topics. Of the total skin disease funding, 82% (91 grants) were categorized as "general cutaneous research." Psoriasis, leprosy, and "other skin and subcutaneous diseases" (ie; immunobullous disorders, vitiligo, and hidradenitis suppurativa) were over-represented when funding was compared with disability. Conversely, cellulitis, decubitus ulcer, urticaria, acne vulgaris, viral skin diseases, fungal skin diseases, scabies, and melanoma were under-represented. Conditions for which disability and funding appeared well-matched were dermatitis, squamous and basal cell carcinoma, pruritus, bacterial skin diseases, and alopecia areata. CONCLUSIONS AND RELEVANCE: Degree of representation in NIAMS is partly correlated with DALY metrics. Grant funding was well-matched with disability metrics for five of the 15 studied skin diseases, while two skin diseases were over-represented and seven were under-represented. Global burden estimates provide increasingly transparent and important information for investigating and prioritizing national research funding allocations.