Ladina Keller, Eveline Hürlimann, Chandni Patel, Sophie Welsche, Somphou Sayasone, Said M Ali, Shaali M Ame, Jean Tenena Coulibaly, Jennifer Keiser
{"title":"在Côte科特迪瓦、老挝人民民主共和国和奔巴岛开展伊维菌素-阿苯达唑抗毛虱随机对照试验获得的见解。","authors":"Ladina Keller, Eveline Hürlimann, Chandni Patel, Sophie Welsche, Somphou Sayasone, Said M Ali, Shaali M Ame, Jean Tenena Coulibaly, Jennifer Keiser","doi":"10.1016/bs.apar.2020.11.001","DOIUrl":null,"url":null,"abstract":"<p><p>There is only limited scientific literature on trial methodology, trial procedures and mitigation strategies to overcome challenges faced during clinical research taking place in resource constrained healthcare environments. Organisational, cultural, infrastructural and ethical challenges may vary between settings although conduct of clinical trials for the same disease (in our case soil-transmitted helminth (STH) infections) share similar risks for implementation. We use the example of a phase III randomised controlled trial, conducted between 2018 and 2020 in Côte d'Ivoire, Lao PDR and Pemba Island (Tanzania), to share challenges faced and mitigation strategies to guide future planning of studies in similar settings. We describe the planning, screening, enrolment and implementation phases in each of the three settings. Our findings indicate that involvement of local staff and close collaboration are essential factors for successful trial preparation and implementation. A strategic plan adapted to each setting with a distinct focus on community engagement and workforce is crucial to proceed efficiently. Mutual trust between the trial population and the trial team is of utmost importance and allows for early reaction and adaption to emerging issues.</p>","PeriodicalId":50854,"journal":{"name":"Advances in Parasitology","volume":"111 ","pages":"253-276"},"PeriodicalIF":0.0000,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/bs.apar.2020.11.001","citationCount":"2","resultStr":"{\"title\":\"Insights gained from conducting a randomised controlled trial on Ivermectin-Albendazole against Trichuris trichiura in Côte d'Ivoire, Lao PDR and Pemba Island.\",\"authors\":\"Ladina Keller, Eveline Hürlimann, Chandni Patel, Sophie Welsche, Somphou Sayasone, Said M Ali, Shaali M Ame, Jean Tenena Coulibaly, Jennifer Keiser\",\"doi\":\"10.1016/bs.apar.2020.11.001\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>There is only limited scientific literature on trial methodology, trial procedures and mitigation strategies to overcome challenges faced during clinical research taking place in resource constrained healthcare environments. Organisational, cultural, infrastructural and ethical challenges may vary between settings although conduct of clinical trials for the same disease (in our case soil-transmitted helminth (STH) infections) share similar risks for implementation. We use the example of a phase III randomised controlled trial, conducted between 2018 and 2020 in Côte d'Ivoire, Lao PDR and Pemba Island (Tanzania), to share challenges faced and mitigation strategies to guide future planning of studies in similar settings. We describe the planning, screening, enrolment and implementation phases in each of the three settings. Our findings indicate that involvement of local staff and close collaboration are essential factors for successful trial preparation and implementation. A strategic plan adapted to each setting with a distinct focus on community engagement and workforce is crucial to proceed efficiently. Mutual trust between the trial population and the trial team is of utmost importance and allows for early reaction and adaption to emerging issues.</p>\",\"PeriodicalId\":50854,\"journal\":{\"name\":\"Advances in Parasitology\",\"volume\":\"111 \",\"pages\":\"253-276\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2021-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://sci-hub-pdf.com/10.1016/bs.apar.2020.11.001\",\"citationCount\":\"2\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Advances in Parasitology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/bs.apar.2020.11.001\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2020/12/19 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"Immunology and Microbiology\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Advances in Parasitology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/bs.apar.2020.11.001","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2020/12/19 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"Immunology and Microbiology","Score":null,"Total":0}
Insights gained from conducting a randomised controlled trial on Ivermectin-Albendazole against Trichuris trichiura in Côte d'Ivoire, Lao PDR and Pemba Island.
There is only limited scientific literature on trial methodology, trial procedures and mitigation strategies to overcome challenges faced during clinical research taking place in resource constrained healthcare environments. Organisational, cultural, infrastructural and ethical challenges may vary between settings although conduct of clinical trials for the same disease (in our case soil-transmitted helminth (STH) infections) share similar risks for implementation. We use the example of a phase III randomised controlled trial, conducted between 2018 and 2020 in Côte d'Ivoire, Lao PDR and Pemba Island (Tanzania), to share challenges faced and mitigation strategies to guide future planning of studies in similar settings. We describe the planning, screening, enrolment and implementation phases in each of the three settings. Our findings indicate that involvement of local staff and close collaboration are essential factors for successful trial preparation and implementation. A strategic plan adapted to each setting with a distinct focus on community engagement and workforce is crucial to proceed efficiently. Mutual trust between the trial population and the trial team is of utmost importance and allows for early reaction and adaption to emerging issues.
期刊介绍:
Advances in Parasitology is recognised as a leading review serial which is consistently well placed in terms of impact factor and citations. Major reviews on all aspects of medical, veterinary and wild-life parasitology are considered. The journal provides an outlet for authoritative reviews from experts in the field. While emphasis is given to modern molecular approaches contributions across all disciplines are encouraged including traditional areas such as ecology and taxonomy. Eclectic volumes are supplemented by thematic volumes dedicated to a particular topic of recognised interest and importance.