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Building psychiatric clinical research capacity in low and middle income countries: The Cuban-Canadian partnership project

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Abstract

Clinical trials research is expanding in low and middle income countries. The capacity to conduct this research should be built using local organizations responsible to local authorities and consistent with international standards of practice. Furthermore, enhancing health research capacity can lead to improvements in care and health human resource competency development. This paper describes the creation, and application of a novel psychopharmacologic clinical research development project conducted in partnership between Cuban and Canadian institutions that illustrates these issues in the domain of mental health.

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... The governance structures adopted by consortia were reported in a third of the papers. Governing bodies were similar across consortia and generally fell into four categories: advisory bodies that provided strategic advice, [56][57][58] steering committees that made strategic and operational decisions, 43 58 59 executive teams responsible for the day-to-day management 58 60 61 and implementation teams that executed consortium activities. 57 62 63 These governing bodies were often made up of representatives from partner institutions. ...
... Governing bodies were similar across consortia and generally fell into four categories: advisory bodies that provided strategic advice, [56][57][58] steering committees that made strategic and operational decisions, 43 58 59 executive teams responsible for the day-to-day management 58 60 61 and implementation teams that executed consortium activities. 57 62 63 These governing bodies were often made up of representatives from partner institutions. However, neither the factors informing the choice of management structure nor the effectiveness of the structures were discussed in any paper. ...
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Background Locally relevant research is considered critical for advancing health and development in low- and middle-income countries (LMICs). Accordingly, health research capacity strengthening (HRCS) efforts have intensified, increasingly through consortia. Yet, the knowledge base for managing such consortia is not well defined. This review aimed to ascertain the scope and quality of published literature on HRCS consortium management processes, management-related factors influencing consortium operations and outcomes, and the knowledge gaps. Methods Given the paucity of published HRCS literature, a ‘systematised review’ as outlined by Grant and Booth was conducted, modelling the systematic review process without restriction to research-based publications. A systematic search in PubMed and Scopus was carried out coupled with a manual search for papers using reference checking and citation searching. A quality appraisal of eligible articles using the Mixed Method Appraisal Tool was undertaken. Thematic synthesis was used to analyse the extracted data. Results The search identified 55 papers, made up of 18 empirical papers and 37 commentaries focusing on consortium-based HRCS initiatives involving LMICs and reporting management-related data. The review indicates increasing efforts being made in the HRCS field in reporting consortia outcomes. However, it highlights the dearth of high-quality empirical research on HRCS consortium management and the nascent nature of the field with most papers published after 2010. The available literature highlights the importance of relational management factors such as equity and power relations in influencing consortium success, though these factors were not explored in depth. Operational management processes and their role in the capacity strengthening pathway were rarely examined. Conclusion Findings indicate a weak evidence base for HRCS consortium management both in terms of quantity and conceptual depth, demonstrating the need for an expanded research effort to inform HRCS practice.
... The academic program included the design and conduction of a multicenter trial to test the efficacy and safety of sertraline compared with placebo in MDD patients. 7 At the time the trial was designed, the first-line treatment for depression in Cuba was the use of tricyclic antidepressants, and sertraline and other SSRIs were not yet available within the National Health Service. Therefore, there was a lack of previous experience-for both clinicians and patients-on the clinical management of SSRIs, efficacy expectations, and adverse effect profile. ...
... It was designed as training in conducting psychopharmacological clinical trials according to Good Clinical Practice guidelines. 7 Factors related to the novelty of the training process and with expectations generated by trialists and transmitted to patients could have had a nonnegligible effect on the results. However, while such factors could explain placebo expectancy and the late-onset efficacy of sertraline, they seem unlikely to bias comparative efficacy due to the randomization and blinding of participants and personnel during the trial. ...
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Purpose: The aim of this study was to assess the efficacy and safety of sertraline compared with placebo in a good clinical practice trial conducted with major depressive disorder patients naive to selective serotonin reuptake inhibitors. Methods: This was a 10-week randomized, multicenter, placebo-controlled, double blind, superiority trial. Adult patients diagnosed with major depressive disorder (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria), total score of 19 to 36 in the 17-item Hamilton Depression Rating Scale (HAMD-17), were randomly allocated to sertraline (n = 39) or placebo (n = 38). Each patient received a fixed dose of sertraline 50 mg/d or placebo for 4 weeks. Afterward a flexible dose up to 200 mg/d was allowed if needed. The primary efficacy end point was clinical response defined as 50% score reduction in HAMD-17 at 10 weeks relative to baseline. Supplementary analysis was performed on HAMD-17 score change from baseline. Findings: The clinical response favored sertraline (72% vs 32%; relative risk, 2.27; 95% confidence interval, 1.37-3.78; P = 0.0006). A linear mixed model showed arm × time interaction was significant (likelihood ratio test χ on 7 df = 48.42, P < 0.0001). The HAMD-17 change score favored sertraline from week 8 onwards. The most frequent adverse events in the sertraline arm were headache, diarrheas, and weight loss. Implications: In this trial, the benefit of sertraline compared with placebo appeared later than usual. The therapeutic process with a close doctor-patient relationship throughout the trial and the effect expectancy due to a new treatment might explain the response delay. Trial registration: RPCEC, ID no. 00000128.
... 'Lessons learned' was allocated to 49% of publications, 'programme description' to 26%, 'recommendations' to 25%, 'programme outputs' to 19%, 'programme outcomes' to 2% and unique codes were allocated to 8%. The quantitative outcome indicators included a measure of knowledge change pre-HRCS and post-HRCS intervention 28 ...
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Objectives Substantial development assistance and research funding are invested in health research capacity strengthening (HRCS) interventions in low-income and middle-income countries, yet the effectiveness, impact and value for money of these investments are not well understood. A major constraint to evidence-informed HRCS intervention has been the disparate nature of the research effort to date. This review aims to map and critically analyse the existing HRCS effort to better understand the level, type, cohesion and conceptual sophistication of the current evidence base. The overall goal of this article is to advance the development of a unified, implementation-focused HRCS science. Methods We used a scoping review methodology to identify peer-reviewed HRCS literature within the following databases: PubMed, Global Health and Scopus. HRCS publications available in English between the period 2000 and 2016 were included. 1195 articles were retrieved of which 172 met the final inclusion criteria. A priori thematic analysis of all included articles was completed. Content analysis of identified HRCS definitions was conducted. Results The number of HRCS publications increased exponentially between 2000 and 2016. Most publications during this period were perspective, opinion or commentary pieces; however, original research publications were the primary publication type since 2013. Twenty-five different definitions of research capacity strengthening were identified, of which three aligned with current HRCS guidelines. Conclusions The review findings indicate that an HRCS research field with a focus on implementation science is emerging, although the conceptual and empirical bases are not yet sufficiently advanced to effectively inform HRCS programme planning. Consolidating an HRCS implementation science therefore presents as a viable option that may accelerate the development of a useful evidence base to inform HRCS programme planning. Identifying an agreed operational definition of HRCS, standardising HRCS-related terminology, developing a needs-based HRCS-specific research agenda and synthesising currently available evidence may be useful first steps.
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The benefits of genomics and biotechnology are concentrated primarily in the industrialized world, while their potential to combat neglected diseases in the developing world has been largely untapped. Without building developing world biotechnology capacity to address local health needs, this disparity will only intensify. To assess the potential of genomics to address health needs in the developing world, the McLaughlin-Rotman Centre for Global Health, along with local partners, organized five courses on Genomics and Public Health Policy in the developing world. The overall objective of the courses was to collectively explore how to best harness genomics to improve health in each region. This article presents and analyzes the recommendations from all five courses. In this paper we analyze recommendations from 232 developing world experts from 58 countries who sought to answer how best to harness biotechnology to improve health in their regions. We divide their recommendations into four categories: science; finance; ethics, society and culture; and politics. The Courses' recommendations can be summarized across the four categories listed above: SCIENCE: - Collaborate through national, regional, and international networks- Survey and build capacity based on proven models through education, training, and needs assessments FINANCE: - Develop regulatory and intellectual property frameworks for commercialization of biotechnology- Enhance funding and affordability of biotechnology- Improve the academic-industry interface and the role of small and medium enterprise ETHICS, SOCIETY, CULTURE: - Develop public engagement strategies to inform and educate the public about developments in genomics and biotechnology- Develop capacity to address ethical, social and cultural issues- Improve accessibility and equity POLITICS: - Strengthen understanding, leadership and support at the political level for biotechnology- Develop policies outlining national biotechnology strategyThese recommendations provide guidance for all those interested in supporting science, technology, and innovation to improve health in the developing world. Applying these recommendations broadly across sectors and regions will empower developing countries themselves to harness the benefits of biotechnology and genomics for billions who have long been excluded.
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The Center of Molecular Immunology in Cuba primarily conducts cancer clinical trials. This article assesses the impact of the implementation of the International Conference on Harmonisation's essential documents on investigative sites. Twenty clinical and sponsor investigators were surveyed about the essential documents twice: before and after the essential documents were implemented. Questions covered the following areas of Good Clinical Practice: ethics, quality assurance, documentation, and design and statistics. Respondents rated activities in these areas as strong (Good Clinical Practice was carried out according to standard operating procedures [SOPs]), weak (the activities of Good Clinical Practice were not carried out and investigators did not know the SOPs, ignored them, or were confused about them), or less known (the activities of Good Clinical Practice were carried out but investigators ignored the SOPs or what they referred to). In the first survey, 35.7% of the activities were rated strong and 38% were rated weak; in the second survey, 64% of the activities were rated strong and 16.6% were rated weak. The strongest area of improvement was design and statistics, which showed a 50% improvement.
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This paper reports on a multidisciplinary meeting held to discuss ethical issues in medical research in the developing world. Many studies, including clinical trials, are conducted in developing countries with a high burden of disease. Conditions under which this research is conducted vary because of differences in culture, public health, political, legal and social contexts specific to these countries. Research practices, including standards of care for participants, may vary as a result. It is therefore not surprising that ethical issues emerge. This meeting sought to identify and discuss these issues from the perspectives of the many actors in such research, including community representatives, with a view to finding ethical and pragmatic solutions to these issues. Dialogue between these actors was also promoted, with a view to identifying the need to develop such dialogue in future. Drawing from the experiences of the speakers, the colloquium attempted to outline some answers to several key questions characterising the field today. Experiences related to epidemiologic research, vaccine trials, drug trials, diagnostic tests and to some fundamental ethical issues in health research. Speakers were from different countries, disciplines and professions. The meeting provided a forum for consultation and debate between different ethics actors. Both encouraging findings and challenges emerged.
Article
BACKGROUND: Depression is frequently unrecognized and undertreated. Therefore, there is a need to increase the knowledge and skills of primary care physicians regarding the diagnosis and treatment of depression. The aim of this study was to provide, and evaluate the impact of, a brief educational program with a number of practice tools and resources in order to improve family physicians' knowledge, diagnosis, and treatment of depression. METHODS: Two educational programs (general and enhanced) were delivered to family physicians interested in depression treatment. The enhanced program focused on more practical clinical issues such as use of diagnostic and symptom assessment tools, recommended dosing of citalopram, how to initiate and discontinue treatment, and relapse prevention. Physicians' knowledge of depression was assessed pretraining and posttraining. Chart audits were conducted for 6 months. Primary endpoints were recognition of depression and pharmacologic management (initial dose, maximum dose, length of treatment, adverse events, and concomitant psychotropic drugs). Secondary endpoints were patient satisfaction with treatment, compliance, withdrawal from the study, treatment outcome, use of adjunctive psychotherapy, and number of office visits. RESULTS: There was a global increase in physicians' knowledge of depression in the short term. Physicians in the enhanced group were more likely to use a symptom-based diagnostic checklist, record the diagnosis of depression, and prescribe the recommended initial dose of citalopram, and they referred less frequently for adjunctive psychotherapy. No difference between educational intervention groups was found in patient satisfaction, compliance, and treatment outcome. CONCLUSIONS: A well-designed brief, simple, and low-cost educational program can increase family physicians' knowledge of depression, improve their diagnostic skills, and optimize their treatment of depression.