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Medical Research

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Today’s global market has multiple standards. Patients in low- and middle-income countries often receive poor-quality medicines. Despite increasing awareness about the issue and the launch of some initiatives, the divide in quality of pharmaceuticals between the North and the South remains great and insufficiently addressed. Amongst other recommendations, this editorial emphasises that there needs to be more advocacy for universal access to quality medicines. It further states that all those who are strongly “involved” with medicines should be targeted: regulators, international organisations, journalists, purchasers, prescribers, program managers, policy makers, public health actors, and the patients. It concludes by stating the fight to ensure universal access to quality medicines needs everyone’s participation, and can only be successful if grounded in common understanding.

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Multidrug-resistant tuberculosis (MDR-TB) is a major threat to global TB control. MDR-TB treatment regimens typically last 20 months or more, require a patient to take a high number of pills, and often lead to unsatisfactory results. This research conclusively proves that a 9–11-month regimen with seven antibiotics can demonstrate high success rates among selected MDR-TB patients in different settings. It further states that greater gains may be possible in contexts where the regimen is more widely applicable.

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Collaborative clinical research that addresses the health needs of low and middle-income countries (LMICs) has become more frequent recently. Such research includes therapeutic and diagnostic trials for neglected tropical diseases (NTDs), and is often conducted by non-commercial groups. Compliance with these international codes may seem a daunting task for small, non-commercial research units working in the NTD domain in LMICs, especially when they assume the role of “sponsor,” i.e., the custodian of compliance with legal and ethical frameworks. In this PLOS collection, we share the experience of clinical research on NTD-related syndromes conducted by the NIDIAG consortium (http://www.nidiag.org/) between 2010 and 2015 in Cambodia, the Democratic Republic of Congo, Indonesia, Ivory Coast, Mali, Nepal, and Sudan. This viewpoint article summarises the main lessons learnt when implementing Good Clinical (Laboratory) Practices (GCLP) in NTD clinical research.

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Trauma is one of the leading causes of death in developing countries – where there is limited access to good quality emergency care. Doctors Without Borders/Médecins Sans Frontières (MSF) delivered a standard package of care in two trauma emergency departments (EDs) in different violence settings: Kunduz, Afghanistan, and Tabarre, Haiti. This study aims to assess whether this standard package resulted in a similar performance in these very different contexts. For the first time, this study supports the plausibility of using the same ED package in different settings. Mapping of patient attendance is essential for planning of human resources needs

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The Doctors Without Borders/Médecins Sans Frontières (MSF) ethics review board (ERB) was solicited in an unprecedented way to provide advice and review research protocols in an ‘emergency’ mode during the recent Ebola epidemic. Twenty-seven Ebola-related study protocols were reviewed between March 2014 and August 2015, which included epidemiological research, behavioural research, infectivity studies and clinical trials with investigational products at (very) early development stages. This article examines the MSF ERB’s experience addressing issues related to the review process and substantive ethical issues in this context. These topics include lack of policies regarding blood sample collection and use, and engaging communities regarding their storage and future use; exclusion of pregnant women from clinical and vaccine trials; and the difficulty of implementing timely and high-quality qualitative/anthropological research to consider potential upfront harms.

Having noticed different standards across ethics committees (ECs), we propose that when multiple ethics reviews of clinical and vaccine trials are carried out during a public health emergency, they should be accompanied by transparent communication between the ECs involved. The MSF ERB experience should trigger a broader discussion on the ‘optimal’ ethics review in an emergency outbreak and what enduring structural changes are needed to improve the ethics review process.

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