Needs-driven talent and competency development for the next generation of regulatory scientists in Africa.

Capacity building programmes for African regulators should link education, training and research with career development in an approach that combines an academic base and experiential learning aligned within a competency framework. A regulatory ecosystem that engages with a broad range of stakeholders will mean that expertise in the ever-expanding field of regulatory science filters into teaching and research in a symbiotic way. In this way capacity development interventions will be a collaborative approach between the learning context (academic and training institutions) and the performance context (regulatory agencies and industry), which will ultimately best serve the patients. Monitoring and evaluation of capacity development interventions will be essential to show value of investments and ultimately guide continued funding and sustainability. This paper reviews the skills and human capacity gaps, reports on regulatory assessment pathways used in Ghana, South Africa and Zimbabwe and outlines a staged tactical approach for Africa that builds on previous efforts to strengthen African regulatory ecosystems.

Evaluating the impact of pulse oximetry on childhood pneumonia mortality in resource-poor settings.

It is estimated that pneumonia is responsible for 15% of childhood deaths worldwide. Recent research has shown that hypoxia and malnutrition are strong predictors of mortality in children hospitalized for pneumonia. It is estimated that 15% of children under 5 who are hospitalized for pneumonia have hypoxaemia and that around 1.5 million children with severe pneumonia require oxygen treatment each year. We developed a deterministic compartmental model that links the care pathway to disease progression to assess the impact of introducing pulse oximetry as a prognostic tool to distinguish severe from non-severe pneumonia in under-5 year olds across 15 countries with the highest burden worldwide. We estimate that, assuming access to supplemental oxygen, pulse oximetry has the potential to avert up to 148,000 deaths if implemented across the 15 countries. By contrast, integrated management of childhood illness alone has a relatively small impact on mortality owing to its low sensitivity. Pulse oximetry can significantly increase the incidence of correctly treated severe cases as well as reduce the incidence of incorrect treatment with antibiotics. We also found that the combination of pulse oximetry with integrated management of childhood illness is highly cost-effective, with median estimates ranging from US$2.97 to $52.92 per disability-adjusted life year averted in the 15 countries analysed. This combination of substantial burden reduction and favourable cost-effectiveness makes pulse oximetry a promising candidate for improving the prognosis for children with pneumonia in resource-poor settings.

Coming together to improve access to medicines: The genesis of the East African Community's Medicines Regulatory Harmonization initiative.

Hiiti Sillo and colleagues reveal how the East African Community's Medicines Regulatory Harmonization initiative improves access to important medicines in Africa.

Eight years of the East African Community Medicines Regulatory Harmonization initiative: Implementation, progress, and lessons learned.

Jane H. Mashingia and colleagues reveal the progress made to date for the East African Community Medicines Regulatory Harmonization initiative.

Peer supervision experiences of drug sellers in a rural district in East-Central Uganda: a qualitative study.

BACKGROUND: Support supervision improves performance outcomes among health workers. However, the national professional guidelines for new licenses and renewal for Class C drug shops in Uganda prescribe self-supervision of licensed private drug sellers. Without support supervision, inappropriate treatment of malaria, pneumonia and diarrhoea among children under 5 years of age continues unabated. This study assessed experiences of drug sellers and peer supervisors at the end of a peer supervision intervention in Luuka District in East Central Uganda. METHODS: Eight in-depth interviews (IDIs) were held with peer supervisors while five focus group discussions (FGDs) were conducted among registered drug sellers at the end of the peer supervision intervention. The study assessed experiences and challenges of peer supervisors and drug sellers regarding peer supervision. Transcripts were imported into Atlas.ti 7 qualitative data management software where they were analysed using thematic content analysis. RESULTS: Initially, peer supervisors were disliked and regarded by drug sellers as another extension of drug inspectors. However, with time a good relationship was established between drug sellers and peer supervisors leading to regular, predictable and supportive peer supervision. This increased confidence of drug sellers in using respiratory timers and rapid diagnostic tests in diagnosing pneumonia symptoms and uncomplicated malaria, respectively, among children under 5 years. There was also an improvement in completing the sick child register which was used for self-assessment by drug sellers. The drug shop association was mentioned as a place where peer supervision should be anchored since it was a one-stop centre for sharing experiences and continuous professional development. Drug sellers proposed including community health workers in monthly drug shop association meetings so that they may also gain from the associated benefits. Untimely completion of the sick child registers by drug sellers and inadequate financial resources were the main peer supervision challenges mentioned. CONCLUSION: Drug sellers benefitted from peer supervision by developing a good relationship with peer supervisors. This relationship guaranteed reliable and predictable supervision ultimately leading to improved treatment practices. There is need to explore the minimum resources needed for peer supervision of drug sellers to further inform practice and policy.

Health worker and policy-maker perspectives on use of intramuscular artesunate for pre-referral and definitive treatment of severe malaria at health posts in Ethiopia.

BACKGROUND: The World Health Organization (WHO) recommends injectable artesunate given either intravenously or by the intramuscular route for definitive treatment for severe malaria and recommends a single intramuscular dose of intramuscular artesunate or intramuscular artemether or intramuscular quinine, in that order of preference as pre-referral treatment when definitive treatment is not possible. Where intramuscular injections are not available, children under 6 years may be administered a single dose of rectal artesunate. Although the current malaria treatment guidelines in Ethiopia recommend intra-rectal artesunate or alternatively intramuscular artemether or intramuscular quinine as pre-referral treatment for severe malaria at the health posts, there are currently no WHO prequalified suppliers of intra-rectal artesunate and when available, its use is limited to children under 6 years of age leaving a gap for the older age groups. Intramuscular artesunate is not part of the drugs recommended for pre-referral treatment in Ethiopia. This study assessed the perspectives of health workers, and policy-makers on the use of intramuscular artesunate as a pre-referral and definitive treatment for severe malaria at the health post level. METHODS: In-depth interviews were held with 101 individuals including health workers, malaria focal persons, and Regional Health Bureaus from Oromia and southern nations, nationalities, and peoples' region, as well as participants from the Federal Ministry of Health and development partners. An interview guide was used in the data collection and thematic content analysis was employed for analysis. RESULTS: Key findings from this study are: (1) provision of intramuscular artesunate as pre-referral and definitive treatment for severe malaria at health posts could be lifesaving; (2) with adequate training, and provision of facilities including beds, health posts can provide definitive treatment for severe malaria using intramuscular artesunate where referral is delayed or not possible; (3) health workers at health centres and hospitals frequently use the intravenous route because it allows for co-administration of other drugs, but they find the intramuscular route easier to use at the health post level; (4) the reasons commonly cited against the management of severe malaria using intramuscular artesunate at health post level were: lack of capacity to manage complications and fear of irrational drug use; (5) use of intramuscular artesunate at health post level will require evidence on safety and feasibility before policy shift. CONCLUSION: From the perspective of health workers, use of intramuscular artesunate as pre-referral treatment of severe malaria cases at the health post is possible but dependent on training and availability of skilled workers. Use of intramuscular artesunate as definitive treatment at health posts was not supported, however, operational research to establish its feasibility, safety and efficacy was recommended to guide any implementation of such an intervention.

Predictors of treatment failure for non-severe childhood pneumonia in developing countries--systematic literature review and expert survey--the first step towards a community focused mHealth risk-assessment tool?

BACKGROUND: Improved referral algorithms for children with non-severe pneumonia at the community level are desirable. We sought to identify predictors of oral antibiotic failure in children who fulfill the case definition of World Health Organization (WHO) non-severe pneumonia. Predictors of greatest interest were those not currently utilized in referral algorithms and feasible to obtain at the community level. METHODS: We systematically reviewed prospective studies reporting independent predictors of oral antibiotic failure for children 2-59 months of age in resource-limited settings with WHO non-severe pneumonia (either fast breathing for age and/or lower chest wall indrawing without danger signs), with an emphasis on predictors not currently utilized for referral and reasonable for community health workers. We searched PubMed, Cochrane, and Embase and qualitatively analyzed publications from 1997-2014. To supplement the limited published evidence in this subject area we also surveyed respiratory experts. RESULTS: Nine studies met criteria, seven of which were performed in south Asia. One eligible study occurred exclusively at the community level. Overall, oral antibiotic failure rates ranged between 7.8-22.9%. Six studies found excess age-adjusted respiratory rate (either WHO-defined very fast breathing for age or 10-15 breaths/min faster than normal WHO age-adjusted thresholds) and four reported young age as predictive for oral antibiotic failure. Of the seven predictors identified by the expert panel, abnormal oxygen saturation and malnutrition were most highly favored per the panel's rankings and comments. CONCLUSIONS: This review identified several candidate predictors of oral antibiotic failure not currently utilized in childhood pneumonia referral algorithms; excess age-specific respiratory rate, young age, abnormal oxygen saturation, and moderate malnutrition. However, the data was limited and there are clear evidence gaps; research in rural, low-resource settings with community health workers is needed.

Cholera surveillance in Uganda: an analysis of notifications for the years 2007-2011.

INTRODUCTION: Cholera outbreaks have occurred periodically in Uganda since 1971. The country has experienced intervals of sporadic cases and localized outbreaks, occasionally resulting in prolonged widespread epidemics. METHODS: Cholera surveillance data reported to the Uganda Ministry of Health from 2007 through 2011 were reviewed to determine trends in annual incidence and case fatality rate. Demographic characteristics of cholera cases were analyzed from the national line list for 2011. Cases were analyzed by district and month of report to understand the geographic distribution and identify any seasonal patterns of disease occurrence. RESULTS: From 2007 through 2011, Uganda registered a total of 7615 cholera cases with 181 deaths (case fatality rate = 2.4%). The absolute number of cases and incidence per 100 000 varied from year to year with the highest incidence occurring in 2008 following heavy rainfall and flooding in eastern Uganda. For 2011, cholera cases occurred in 1.6 times more males than females. The geographical areas affected by the outbreaks shifted each year, with the exception of a few endemic districts. No clear seasonal trends in cholera occurrence were identified for this time period. CONCLUSIONS: We observed an overall decline in cases reported during the 5 years under review. During this period, concerted efforts were made by the Ugandan government and development partners to educate communities on proper sanitation and hygiene and provide safe water and timely treatment. Mechanisms to ensure timely and complete cholera surveillance data are reported to the national level should continue to be strengthened.

Use of traditional medicine for the treatment of diabetes in Eastern Uganda: a qualitative exploration of reasons for choice.

BACKGROUND: While there are biomedical drugs for managing diabetes mellitus, some patients with diabetes use traditional medicine. The aim of the study was to explore why patients with diabetes use traditional medicine for the treatment of diabetes. METHODS: The study was conducted in Iganga and Bugiri districts in Eastern Uganda using four focus group discussions (FGDs) with patients with diabetes; two with female patients and two with male patients, thirteen key informant interviews (KIIs); nine with health workers working with patients with diabetes and four with herbalists. FGDs and KIIs focused on what respondents perceived as reasons for patients with diabetes taking traditional medicine. Analysis was done using content analysis. RESULTS: Reasons for taking traditional medicine included finding difficulties accessing hospitals, diabetic drugs being out of stock, traditional medicine being acceptable and available within community, as well as being supplied in big quantities. Others were traditional medicine being cheaper than biomedical treatment and payment for it being done in installments. Traditional medicine was also more convenient to take and was marketed aggressively by the herbalists. Influence of family and friends as well as traditional healers contributed to use of traditional medicine. CONCLUSIONS: Possibilities of putting diabetic drugs at facilities closer to patients need to be considered and health facilities should have a constant supply of diabetic drugs. Community members need to be sensitized on the proper treatment for diabetes mellitus and on the dangers of taking traditional medicine.

Access, acceptability and utilization of community health workers using diagnostics for case management of fever in Ugandan children: a cross-sectional study.

BACKGROUND: Use of diagnostics in integrated community case management (iCCM) of fever is recognized as an important step in improving rational use of drugs and quality of care for febrile under-five children. This study assessed household access, acceptability and utilization of community health workers (CHWs) trained and provided with malaria rapid diagnostic tests (RDTs) and respiratory rate timers (RRTs) to practice iCCM. METHODS: A total of 423 households with under-five children were enrolled into the study in Iganga district, Uganda. Households were selected from seven villages in Namungalwe sub-county using probability proportionate to size sampling. A semi-structured questionnaire was administered to caregivers in selected households. Data were entered into Epidata statistical software, and analysed using SPSS Statistics 17.0, and STATA version 10. RESULTS: Most (86%, 365/423) households resided within a kilometre of a CHW's home, compared to 26% (111/423) residing within 1 km of a health facility (p < 0.001). The median walking time by caregivers to a CHW was 10 minutes (IQR 5-20). The first option for care for febrile children in the month preceding the survey was CHWs (40%, 242/601), followed by drug shops (33%, 196/601).Fifty-seven percent (243/423) of caregivers took their febrile children to a CHW at least once in the three month period preceding the survey. Households located 1-3 km from a health facility were 72% (AOR 1.72; 95% CI 1.11-2.68) more likely to utilize CHW services compared to households within 1 km of a health facility. Households located 1-3 km from a CHW were 81% (AOR 0.19; 95% CI 0.10-0.36) less likely to utilize CHW services compared to those households residing within 1 km of a CHW.A majority (79%, 336/423) of respondents thought CHWs services were better with RDTs, and 89% (375/423) approved CHWs' continued use of RDTs. Eighty-six percent (209/243) of respondents who visited a CHW thought RRTs were useful. CONCLUSION: ICCM with diagnostics is acceptable, increases access, and is the first choice for caregivers of febrile children. More than half of caregivers of febrile children utilized CHW services over a three-month period. However, one-third of caregivers used drug shops in spite of the presence of CHWs.

Predictors for health facility delivery in Busia district of Uganda: a cross sectional study.

BACKGROUND: Among the factors contributing to the high maternal morbidity and mortality in Uganda is the high proportion of pregnant women who do not deliver under supervision in health facilities. This study aimed to identify the independent predictors of health facility delivery in Busia a rural district in Uganda with a view of suggesting measures for remedial action. METHODS: In a cross sectional survey, 500 women who had a delivery in the past two years (from November 16 2005 to November 15 2007) were interviewed regarding place of delivery, demographic characteristics, reproductive history, attendance for antenatal care, accessibility of health services, preferred delivery positions, preference for disposal of placenta and mother's autonomy in decision making. In addition the household socio economic status was assessed. The independent predictors of health facility delivery were identified by comparing women who delivered in health facilities to those who did not, using bivariate and binary logistic regression analysis. RESULTS: Eight independent predictors that favoured delivery in a health facility include: being of high socio-economic status (adjusted odds ratio [AOR] 2.8 95% Confidence interval [95% CI]1.2-6.3), previous difficult delivery (AOR 4.2, 95% CI 3.0-8.0), parity less than four (AOR 2.9, 95% CI 1.6-5.6), preference of supine position for second stage of labour (AOR 5.9, 95% CI 3.5-11.1) preferring health workers to dispose the placenta (AOR 12.1, 95% CI 4.3-34.1), not having difficulty with transport (AOR 2.0, 95% CI 1.2-3.5), being autonomous in decision to attend antenatal care (AOR 1.9, 95% CI 1.1-3.4) and depending on other people (e.g. spouse) in making a decision of where to deliver from (AOR 2.4, 95% CI 1.4-4.6). A model with these 8 variables had an overall correct classification of 81.4% (chi square = 230.3, P < 0.001). CONCLUSIONS: These data suggest that in order to increase health facility deliveries there is need for reaching women of low social economic status and of higher parity with suitable interventions aimed at reducing barriers that make women less likely to deliver in health units such as ensuring availability of transport and involving spouses in the birth plan.

Positioning Africa's public health doctoral students to lead societal transformation and development.

The public health context is becoming increasingly more complex requiring highly trained professionals equipped with knowledge, competencies and tools to address or transform current and future challenges. Doctoral degree training offers an opportunity to build the capacity to detect and respond to such dynamic health challenges. In this paper, we discuss how Africa's public health doctoral students can be better positioned for the different career pathways to provide leadership on complex health and development challenges. Public health PhD graduates can take up careers in academia, civil service, private sector and civil society, among others. To thrive in these pathways, PhD training should equip them with knowledge, skills and competencies in leadership, creativity and social competence among others. To produce career-ready PhD graduates, there is need to rethink training curricula to build critical skills for diverse career pathways, introduce students to entrepreneurship, and enhance linkages between universities and industry. Experiential learning, exposure to networks and partnerships, postdoctoral programmes and mentorship and exchange programmes can further equip PhD students with key knowledge, skills and competencies. For students to position themselves for the different careers, they ought to plan their careers early, albeit with flexibility. Students should build their soft skills and embrace technology among other transferable competencies. By identifying potential career pathways and being positioned for these early, Africa can produce transformative PhD students on a path for success not just for themselves but for society at large, including in new environments such as that created by COVID-19.

Effectiveness of peer-supervision on pediatric fever illness treatment among registered private drug sellers in East-Central Uganda: An interrupted time series analysis.

RATIONALE AIMS AND OBJECTIVES: Appropriate treatment of pediatric fever in rural areas remains a challenge and maybe partly due to inadequate supervision of licensed drug sellers. This study assessed the effectiveness of peer-supervision among drug sellers on the appropriate treatment of pneumonia symptoms, uncomplicated malaria, and non-bloody diarrhea among children less than 5 years of age in the intervention (Luuka) and comparison (Buyende) districts, in East-Central Uganda. METHODS: Data on pneumonia symptoms, uncomplicated malaria, and non-bloody diarrhea among children less than 5 years of age was abstracted from drug shop sick child registers over a 12-month period; 6 months before and 6 months after the introduction of peer-supervision. Interrupted time series were applied to determine the effectiveness of the peer-supervision intervention on the appropriate treatment of pneumonia, uncomplicated malaria, and non-bloody diarrhea among children less than 5 years of age attending drug shops in East Central Uganda. RESULTS: The proportion of children treated appropriately for pneumonia symptoms was 10.84% (P < .05, CI = [1.75, 19.9]) higher, for uncomplicated malaria was 1.46% (P = .79, CI = [-10.43, 13.36]) higher, and for non-bloody diarrhea was 4.00% (P < .05, CI = [-7.95, -0.13]) lower in the intervention district than the comparison district, respectively.Post-intervention trend results showed an increase of 1.21% (P = .008, CI = [0.36, 2.05]) in the proportion appropriately treated for pneumonia symptoms, no difference in appropriate treatment for uncomplicated malaria, and a reduction of 1% (P < .06, CI = [-1.95, 0.02]) in the proportion of children appropriately treated for non-bloody diarrhea, respectively. CONCLUSIONS: Peer-supervision increased the proportion of children less than 5 years of age that received appropriate treatment for pneumonia symptoms but not for uncomplicated malaria and non-bloody diarrhea. Implementation of community-level interventions to improve pediatric fever management should consider including peer-supervision among drug sellers.

Community acceptability of use of rapid diagnostic tests for malaria by community health workers in Uganda.

BACKGROUND: Many malarious countries plan to introduce artemisinin combination therapy (ACT) at community level using community health workers (CHWs) for treatment of uncomplicated malaria. Use of ACT with reliance on presumptive diagnosis may lead to excessive use, increased costs and rise of drug resistance. Use of rapid diagnostic tests (RDTs) could address these challenges but only if the communities will accept their use by CHWs. This study assessed community acceptability of the use of RDTs by Ugandan CHWs, locally referred to as community medicine distributors (CMDs). METHODS: The study was conducted in Iganga district using 10 focus group discussions (FGDs) with CMDs and caregivers of children under five years, and 10 key informant interviews (KIIs) with health workers and community leaders. Pre-designed FGD and KII guides were used to collect data. Manifest content analysis was used to explore issues of trust and confidence in CMDs, stigma associated with drawing blood from children, community willingness for CMDs to use RDTs, and challenges anticipated to be faced by the CMDs. RESULTS: CMDs are trusted by their communities because of their commitment to voluntary service, access, and the perceived effectiveness of anti-malarial drugs they provide. Some community members expressed fear that the blood collected could be used for HIV testing, the procedure could infect children with HIV, and the blood samples could be used for witchcraft. Education level of CMDs is important in their acceptability by the community, who welcome the use of RDTs given that the CMDs are trained and supported. Anticipated challenges for CMDs included transport for patient follow-up and picking supplies, adults demanding to be tested, and caregivers insisting their children be treated instead of being referred. CONCLUSION: Use of RDTs by CMDs is likely to be acceptable by community members given that CMDs are properly trained, and receive regular technical supervision and logistical support. A well-designed behaviour change communication strategy is needed to address the anticipated programmatic challenges as well as community fears and stigma about drawing blood. Level of formal education may have to be a criterion for CMD selection into programmes deploying RDTs.

Field Epidemiology Training Programmes in Africa - Where are the Graduates?

BACKGROUND: The current shortage of human resources for health threatens the attainment of the Millennium Development Goals. There is currently limited published evidence of health-related training programmes in Africa that have produced graduates, who remain and work in their countries after graduation. However, anecdotal evidence suggests that the majority of graduates of field epidemiology training programmes (FETPs) in Africa stay on to work in their home countries--many as valuable resources to overstretched health systems. METHODS: Alumni data from African FETPs were reviewed in order to establish graduate retention. Retention was defined as a graduate staying and working in their home country for at least 3 years after graduation. African FETPs are located in Burkina Faso, Ethiopia, Ghana, Kenya, Nigeria, Rwanda, South Africa, the United Republic of Tanzania, Uganda and Zimbabwe. However, this paper only includes the Uganda and Zimbabwe FETPs, as all the others are recent programmes. RESULTS: This review shows that enrolment increased over the years, and that there is high graduate retention, with 85.1% (223/261) of graduates working within country of training; most working with Ministries of Health (46.2%; 105/261) and non-governmental organizations (17.5%; 40/261). Retention of graduates with a medical undergraduate degree was higher (Zimbabwe 80% [36/83]; Uganda 90.6% [125/178]) than for those with other undergraduate qualifications (Zimbabwe 71.1% [27/83]; Uganda 87.5% [35/178]). CONCLUSIONS: African FETPs have unique features which may explain their high retention of graduates. These include: programme ownership by ministries of health and local universities; well defined career paths; competence-based training coupled with a focus on field practice during training; awarding degrees upon completion; extensive training and research opportunities made available to graduates; and the social capital acquired during training.

Laboratory capacity building for the International Health Regulations (IHR[2005]) in resource-poor countries: the experience of the African Field Epidemiology Network (AFENET).

Laboratory is one of the core capacities that countries must develop for the implementation of the International Health Regulations (IHR[2005]) since laboratory services play a major role in all the key processes of detection, assessment, response, notification, and monitoring of events. While developed countries easily adapt their well-organized routine laboratory services, resource-limited countries need considerable capacity building as many gaps still exist. In this paper, we discuss some of the efforts made by the African Field Epidemiology Network (AFENET) in supporting laboratory capacity development in the Africa region. The efforts range from promoting graduate level training programs to building advanced technical, managerial and leadership skills to in-service short course training for peripheral laboratory staff. A number of specific projects focus on external quality assurance, basic laboratory information systems, strengthening laboratory management towards accreditation, equipment calibration, harmonization of training materials, networking and provision of pre-packaged laboratory kits to support outbreak investigation. Available evidence indicates a positive effect of these efforts on laboratory capacity in the region. However, many opportunities exist, especially to support the roll-out of these projects as well as attending to some additional critical areas such as biosafety and biosecuity. We conclude that AFENET's approach of strengthening national and sub-national systems provide a model that could be adopted in resource-limited settings such as sub-Saharan Africa.

Strengthening public health surveillance and response using the health systems strengthening agenda in developing countries.

There is increased interest in strengthening health systems for developing countries. However, at present, there is common uncertainty about how to accomplish this task. Specifically, several nations are faced with an immense challenge of revamping an entire system. To accomplish this, it is essential to first identify the components of the system that require modification. The World Health Organization (WHO) has proposed health system building blocks, which are now widely recognized as essential components of health systems strengthening.With increased travel and urbanization, the threat of emerging diseases of pandemic potential is increasing alongside endemic diseases such as human immunodeficiency virus (HIV), tuberculosis (TB), malaria, and hepatitis virus infections. At the same time, the epidemiologic patterns are shifting, giving rise to a concurrent increase in disease burden due to non-communicable diseases. These diseases can be addressed by public health surveillance and response systems that are operated by competent public health workers in core public health positions at national and sub-national levels with a focus on disease prevention.We describe two ways that health ministries in developing countries could leverage President Obama's Global Health Initiative (GHI) to build public health surveillance and response systems using proven models for public health systems strengthening and to create the public health workforce to operate those systems. We also offer suggestions for how health ministries could strengthen public health systems within the broad health systems strengthening agenda. Existing programs (e.g., the Global Vaccine Alliance [GAVI] and the Global Fund Against Tuberculosis, AIDS, and Malaria [GFTAM]) can also adapt their current health systems strengthening programs to build sustainable public health systems.

Scientific considerations for global drug development.

Requiring regional or in-country confirmatory clinical trials before approval of drugs already approved elsewhere delays access to medicines in low- and middle-income countries and raises drug costs. Here, we discuss the scientific and technological advances that may reduce the need for in-country or in-region clinical trials for drugs approved in other countries and limitations of these advances that could necessitate in-region clinical studies.