COVID Challenges for Trials in Low-to-Middle-Income Countries

ABSTRACT

While the substantial majority of clinical trials still take place in countries classified by the World Bank as high income, a review of clinical trial registrations on the World Health Organization (WHO) International Clinical Trials Registry Platform and clinicaltrials.gov shows that a significant and growing number are being conducted in LMICs, with major centers in Eastern Europe, the Middle East, Brazil, China, India, and South Africa. COVID-19 will likely have a longlasting effect on global supply chains.11 The U.S. and more than 50 other countries are restricting or considering restrictions on exports of supplies that are needed to mitigate the effects of COVID-19 locally.12 Internationally, the World Trade Organization and the World Customs Organization issued a joint statement noting the disruptive impact of the virus on global supply chains and pledged to cooperate to facilitate trade in essential goods.13 LMICs are struggling to obtain limited hospital supplies in the global market in competition with the U.S., the European Union, Japan, and similar high-income buyers, as recent reporting about the COVID-19 outbreak in Nigeria shows.14 Clinical trial sites in LMICs that cannot obtain needed supplies in-country could obtain them from a study sponsor, assuming the products can be legally imported and shipments to that country are not cost-prohibitive in light of global freight and logistic disruptions. [...]informed consent forms and study institutional review board (IRB) and independent ethics committee (IEC) approvals may need to be revisited in light of local conditions. Clint D. Hermes is an attorney at Bass, Berry & Sims References 1. https//main.icmr.nic.in/sites/default/files/guidelines/EC_Guidance_ COVID19_06_05_2020.pdf 2. http//www.sahpra.org.za/wp-content/uploads/2020/03/SAHPRACommunication_COVID_19-Final-25032020.pdf 3. https//pharmacyboardkenya.org/files/?file=Clinical_Trials_During_ COVID-19_Pandemic.pdf 4. http//portal.anvisa.gov.br/documents/219201/4340788/SEI_ ANVISA+-+0989653+-+Nota+Técnica14.pdf/6b48273f-550f-47618ba1-4e731a87b526 5. https//www.gob.mx/cofepris/articulos/medidas-extraordinarias-enrelacion-a-estudios-clinicos-ante-la-pandemia-de-covid-19 6. https//ensayosclinicos-repec.ins.gob.pe/images/Nueva_actualización_12.12.19/Actualización_2020/Comunicado_N_002-2020.pdf 7. https//www.imf.org/en/Topics/imf-and-covid19/Policy-Responsesto-COVID-19 8. https//www.bsg.ox.ac.uk/research/research-projects/coronavirusgovernment-response-tracker 9. https//covidtracker.bsg.ox.ac.uk/stringency-map 10.https//www.who.int/news-room/commentaries/detail/immunitypassports-in-the-context-of-covid-19 11. https//www.weforum.org/agenda/2020/04/supply-chains-leadership-business-economics-trade-coronavirus-covid19/ 12. https//www.weforum.org/agenda/2020/03/covid-19-coronaviruslessons-past-supply-chain-disruptions/ 13.http//www.wcoomd.org/en/media/newsroom/2020/april/wco-wtojoint-statement-on-covid-19-related-trade-measures.aspx 14.https//www.nytimes.com/2020/05/17/world/africa/coronaviruskano-nigeria-hotspot.html 15. https//mp.weixin.qq.com/s/amB7fBxLw8KSR9DcUsbTWg