English (United Kingdom)

https://curated-unify.zendy.io/wp-json/zendy-region/v1/featured_content/oa?rat=en

https://curated-unify.zendy.io/wp-json/zendy-region/v1/highlighted_journal/

Global: Zendy Plus annual

Presents the access of premium content as premium feature

Premium Content

Presents the keyphrase highlighting as premium feature

Keyphrase Highlighting

Presents the summarisation as premium feature

Summarisation

Insights

Presents the pdf analysis as premium feature

PDF Analysis

Presents the zaia usage as premium feature

ZAIA

Global: Zendy Tools annual

Global: Zendy Free Plan

Global: Zendy Tools monthly

Global: Zendy Plus monthly

By most estimates, about one billion people worldwide are affected by neglected tropical diseases (NTDs). These diseases are found primarily in developing countries, and those affected are generally marginalized sectors of the population that may not have access to safe water, good hygiene, or adequate medicines. NTDs cause major health problems, and often lead to permanent disability of the victims. Consequently, the social and economic impact of these diseases is massive [1].  With the growing recognition of the deleterious effects of the NTDs, several initiatives are now underway at national and international levels to tackle the problem with the aim of controlling or eliminating them. The drive to contain or eliminate the diseases has further been highlighted in numerous papers [1]–[10], through persistent advocacy of the World Health Organization (WHO) and other institutions [11]–[13], and by funding from government, private, and corporate grants.  An approach that has received wide acceptance in recent years is an integrated strategy that involves mass administration of combination treatments [4], [9]–[15]. This is particularly the case when two or more of the NTDs share a common method of management. The initial emphasis of this approach has been on the seven NTDs: the three soil-transmitted helminthiases (caused by whipworm, hookworm, and roundworm), schistosomiasis, lymphatic filariasis (LF), trachoma, and onchocerciasis. The integrated approach typically involves coordinated use of therapy according to established guidelines, leveraging disease-control activities within the national health system, and active involvement of the community. When the strategy comprises mass drug administration (MDA), the whole endemic population is normally targeted for treatment.  Given the proven efficacy of the individual drugs, an essential facet of the integrated programs is assessment of the safety of the combination therapy in the target population. Accordingly, there is a growing list of studies that have been conducted to evaluate the safety of co-administration of drugs [16]–[19].  Although there is an obvious appreciation of the need to conduct studies to establish the safety of combination drugs in MDA, there has been no public discussion on what guidance may be needed to help researchers in these resource-constrained areas to design, conduct, and analyze such studies. The objective of this policy platform is, therefore, to initiate discussion on this topic, with particular reference to data handling, safety assessment, and other aspects of pharmacovigilance that should be considered to protect the well-being of the target population. Examples will be provided from two studies. The first study [16] was performed in Zanzibar (the “Zanzibar study”) and examined co-administration of ivermectin, albendazole, and praziquantel in children and adults. The second illustrative study pertains to a triple co-administration of azithromycin, ivermectin, and albendazole for the treatment of trachoma and LF (the “trachoma/LF study”). At the time of preparation of this manuscript, preliminary pharmacokinetic (PK) studies for the latter have been reported [15],[17].  While the scope of the this policy platform is the conduct and reporting of MDA studies, it may be worthwhile to note the main features that distinguish such studies from conventional clinical trials for efficacy. In the last section, some relevant aspects of the two types are discussed, with emphasis on compliance requirements and subject inclusion and exclusion criteria.

Considerations for the Design and Conduct of a Pharmacovigilance Study Involving Mass Drug Administration in a Resource-Constrained Setting