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      Implementation challenges and lessons learned from the STREAM clinical trial—a survey of trial sites

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          Abstract

          Background

          Design and implementation of multi-country clinical trials for multidrug-resistant tuberculosis (MDR-TB) are complex for several reasons, including trial duration, varying levels of experience and infrastructure across settings, and different regulatory requirements. STREAM was an MDR-TB clinical trial that recruited over 1000 participants. We documented challenges and best practices/lessons learned from the site perspective to improve implementation of future trials.

          Methods

          We conducted a voluntary survey of trial staff at all sites to obtain information on challenges encountered and best practices/lessons learned from implementation of the STREAM trial. Respondents were asked to identify substantive aspects of trial implementation from a list that included: trial administration, laboratory strengthening/infrastructure, pharmacy and supply chain management, community engagement, regulatory and ethics requirements, health economics, and other (respondent designated) about which a practical guide would be useful to improve future trial implementation. For each aspect of trial implementation selected, respondents were asked to report challenges and best practices/lessons learned during STREAM. Lastly, respondents were asked to list up to three things they would do differently when implementing future trials. Summary statistics were generated for quantitative data and thematic analysis was undertaken for qualitative data.

          Results

          Of 67 responses received from 13 of 15 sites, 47 (70%) were included in the analyses, after excluding duplicate or incomplete responses. Approximately half the respondents were investigators or trial coordinators. The top three aspects of trial implementation identified for a best practices/lessons learned practical guide to improve future trial implementation were: trial administration, community engagement, and laboratory strengthening/infrastructure. For both challenges and best practices/lessons learned, three common themes were identified across different aspects of trial implementation. Investment in capacity building and ongoing monitoring; investment in infrastructure and well-designed trial processes; and communication and coordination between staff and meaningful engagement of stakeholders were all thought to be critical to successful trial implementation.

          Conclusions

          Existing practices for clinical trial implementation should be reevaluated. Sponsors should consider the local context and the need to increase upfront investment in the cross-cutting thematic areas identified to improve trial implementation.

          Supplementary Information

          The online version contains supplementary material available at 10.1186/s13063-023-07068-8.

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          Most cited references17

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          Barriers for conducting clinical trials in developing countries- a systematic review

          Background Clinical trials for identification of efficient and effective new diagnostic and treatment modalities are needed to address disproportionately high burden of communicable (e.g., HIV/AIDS, tuberculosis, and malaria) and non-communicable diseases (e.g., diabetes) in developing countries. However, gross under-representation in global clinical trial platforms contributes to sustained health inequity in these countries. We reviewed the literature on barriers facing clinical researchers in developing countries for conducting clinical trials in their countries. Methods Literature indexed in PubMed, Embase, CINAHL and Web of Science, WHO Global Health Library were searched. Grey literature was also searched. Search key words included barriers, challenges, clinical trials and developing countries. Articles within the scope of this review were appraised by two reviewers. Results Ten studies, which are reported in 15 papers, were included in this review. Following critical review we identified five unifying themes for barriers. Barriers for conducting clinical trials included lack of financial and human capacity, ethical and regulatory system obstacles, lack of research environment, operational barriers and competing demands. Conclusion and recommendation There were substantial barriers at system, organization and individual level. We propose that to address this problem, instituting a system for wider implementation of local investigator-initiated trials is warranted. These trials are more applicable to local populations because they build on local healthcare knowledge. They are more demand-led, influence policy and responsive to a country’s needs because they are driven by a local or national agenda. Electronic supplementary material The online version of this article (10.1186/s12939-018-0748-6) contains supplementary material, which is available to authorized users.
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            A Trial of a Shorter Regimen for Rifampin-Resistant Tuberculosis

            Cohort studies in Bangladesh showed promising cure rates among patients with multidrug-resistant tuberculosis who received existing drugs in regimens shorter than that recommended by the World Health Organization (WHO) in 2011.
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              Challenges in tuberculosis drug research and development.

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                Author and article information

                Contributors
                lnpatel@gmail.com
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                23 January 2023
                23 January 2023
                2023
                : 24
                : 51
                Affiliations
                [1 ]GRID grid.475681.9, Vital Strategies, ; 100 Broadway, 4th Floor, New York, NY 10005 USA
                [2 ]Vital Strategies Health Systems, Asia Pacific, Singapore, Singapore
                [3 ]GRID grid.415052.7, ISNI 0000 0004 0606 323X, Medical Research Council Clinical Trials Unit at UCL, ; London, England
                Author information
                http://orcid.org/0000-0002-1099-3638
                Article
                7068
                10.1186/s13063-023-07068-8
                9869607
                36691098
                c597f7fb-b009-484a-ab00-9824ad3db6dc
                © The Author(s) 2023

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                : 20 October 2022
                : 3 January 2023
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100000200, United States Agency for International Development;
                Award ID: GHN-A-00-08-00004
                Funded by: United Kingdom Medical Research Council
                Funded by: United Kingdom Department for International Development
                Funded by: FundRef http://dx.doi.org/10.13039/100008897, Janssen Pharmaceuticals;
                Categories
                Research
                Custom metadata
                © The Author(s) 2023

                Medicine
                mdr-tb,trial implementation,challenges,lessons learned,best practices,site perspective
                Medicine
                mdr-tb, trial implementation, challenges, lessons learned, best practices, site perspective

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