Investing in Late-Stage Clinical Trials and Manufacturing of Neglected Disease Product Candidates – Modeling the Benefits and Costs of Investments for Three Middle-Income Countries

2021 ◽  
Author(s):  
Marco Schäferhoff ◽  
Armand Zimmerman ◽  
Mohamed Mustafa Diab ◽  
Wenhui Mao ◽  
Vipul Chowdhary ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Late Stage ◽  
Middle Income ◽  
Neglected Disease ◽  
Middle Income Countries ◽  
Benefits And Costs

Developing an Aggregator Mechanism for Late-Stage Clinical Trials of Neglected Disease Product Candidates

2020 ◽  
Author(s):  
Gavin Yamey ◽  
Marco Schäferhoff ◽  
Mary H. Moran ◽  
Mohamed Mustafa Diab ◽  
Kaci Kennedy McDade ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Late Stage ◽  
Neglected Disease

Mobile Mental Health for Depression Assistance

2022 ◽  
pp. 21-40
Author(s):  
Jorge Magalhães Rodrigues ◽  
Frédéric Oliveira ◽  
Carolina Porto Ribeiro ◽  
Regina Camargo Santos
Keyword(s):  
Mental Health ◽  
Clinical Trials ◽  
Mobile Health ◽  
Medical Illness ◽  
Middle Income ◽  
Middle Income Countries ◽  
Promising Tool ◽  
Key Concepts ◽  
Mobile Mental Health ◽  
Effective Treatments

Depression is a prevalent and severe medical illness that negatively affects how people feel, think, and act, with estimates pointing towards more than 300 million suffering from depression worldwide. Although effective treatments exist, about 80% of people in low and middle-income countries do not receive therapy. Therefore, technology has become a promising tool to assist in reducing disparities. This study aims to identify and map the available evidence on mobile health applied to depression and clarify key concepts. The authors analyzed clinical trials developed over the last five years. EBSCO and PubMed were searched, and a total of 14 conducted RCTs were selected and reviewed. Despite some limitations regarding dropout rates and several ethical and safety concerns, the mobile mental health future seems promising.

Human papillomavirus (HPV) vaccination: from clinical studies to immunization programs

2019 ◽  
Vol 29 (8) ◽  
pp. 1317-1326 ◽  
Author(s):  
Raúl Murillo ◽  
Camila Ordóñez- Reyes
Keyword(s):  
Cervical Cancer ◽  
Clinical Trials ◽  
Human Papillomavirus ◽  
Hpv Vaccine ◽  
Hpv Vaccination ◽  
Population Based ◽  
Immunization Programs ◽  
Hpv Vaccines ◽  
Middle Income ◽  
Middle Income Countries

Cervical cancer incidence and mortality have decreased in high-income countries, but low- and middle-income countries continue to bear a significant burden from the disease. Human papillomavirus (HPV) vaccines are a promising alternative for disease control; however, their introduction is slow in settings with greater need. We conducted a review of HPV vaccine efficacy and effectiveness reported in clinical trials and population-based studies. Efficacy of HPV vaccines is close to 100% when using a three-dose schedule in HPV-negative young women (<25 years old) for protection against persistent infection and HPV vaccine-type associated pre-cancerous lesions. Furthermore, sustained protection for up to 12 years of follow-up has been demonstrated; cross-protection against non-vaccine types is particularly observed for the bivalent vaccine, and preliminary data regarding impact on invasive cancer have emerged. Given its lower efficacy, catch-up vaccination beyond 19 years of age and proposals for vaccinating adult women deserve careful evaluation in accurately designed studies and economic analyses. Despite positive results regarding immunogenicity and post-hoc analysis for cervical intra-epithelial neoplasia in clinical trials, population-based data for prime and booster two-dose schedules are not available. Evaluation of vaccine safety from surveillance systems in immunization programs that have already distributed more than 270 million doses found no association of HPV vaccination with serious side effects. The introduction of HPV vaccination in national immunization programs remains the main challenge in tackling the burden of cervical cancer (up to 2018, only 89 countries have introduced vaccination worldwide, and most of these are high-income countries). Access models and technical capacity require further development to help low- and middle-income countries to increase the pace of vaccine delivery. Alternative approaches such as one-dose schedules and vaccination at younger ages may help reduce the programmatic and economic challenges to adolescent vaccination.

scholarly journals Strategies for developing sustainable health research capacity in low and middle-income countries: a prospective, qualitative study investigating the barriers and enablers to locally led clinical trial conduct in Ethiopia, Cameroon and Sri Lanka

BMJ Open ◽  
2017 ◽  
Vol 7 (10) ◽  
pp. e017246 ◽  
Author(s):  
Samuel R P Franzen ◽  
Clare Chandler ◽  
Sisira Siribaddana ◽  
Julius Atashili ◽  
Brian Angus ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Necessary Conditions ◽  
Evidence Based ◽  
Middle Income ◽  
Trial Conduct ◽  
Middle Income Countries ◽  
Barriers And Enablers ◽  
Research Systems ◽  
Clinical Trial Conduct

ObjectivesIn 2013, the WHO stated that unless low-income and middle-income countries (LMICs) become producers of research, health goals would be hard to achieve. Among the capacities required to build a local evidence base, ability to conduct clinical trials is important. There is no evidence-based guidance for the best ways to develop locally led trial capacity. This research aims to identify the barriers and enablers to locally led clinical trial conduct in LMICs and determine strategies for their sustainable development.DesignProspective, multiple case study design consisting of interviews (n=34), focus group discussions (n=13) and process mapping exercises (n=10).SettingCase studies took place in Ethiopia (2011), Cameroon (2012) and Sri Lanka (2013).ParticipantsLocal health researchers with previous experiences of clinical trials or stakeholders with an interest in trials were purposively selected through registration searches and snowball sampling (n=100).Primary and secondary outcome measuresDiscussion notes and transcripts were analysed using thematic coding analysis. Key themes and mechanisms were identified.ResultsInstitutions and individuals were variably successful at conducting trials, but there were strong commonalities in the barriers and enablers across all levels and functions of the research systems. Transferable mechanisms were summarised into the necessary conditions for trial undertaking, which included: awareness of research, motivation, knowledge and technical skills, leadership capabilities, forming collaborations, inclusive trial operations, policy relevance and uptake and macro and institutional strengthening.ConclusionsBarriers and enablers to locally led trial undertaking exist at all levels and functions of LMIC research systems. Establishing the necessary conditions to facilitate this research will require multiple, coordinated interventions that seek to resolve them in a systemic manner. The strategies presented in the discussion provide an evidence-based framework for a self-sustaining capacity development approach. This represents an important contribution to the literature that will be relevant for research funders, users and producers.

Stakeholder Views of Clinical Trials in Low- and Middle-Income Countries: A Systematic Review

PEDIATRICS ◽  
2016 ◽  
Vol 137 (2) ◽  
pp. e20152800-e20152800 ◽  
Author(s):  
P. D. Joseph ◽  
P. H. Y. Caldwell ◽  
A. Tong ◽  
C. S. Hanson ◽  
J. C. Craig
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Middle Income ◽  
Stakeholder Views ◽  
Middle Income Countries ◽  
Low And Middle Income

scholarly journals Waste of Research. Is There Any Solution? “Beginning from the Beginning” instead of “Beginning from the End”

2020 ◽  
Vol 26 (1) ◽  
Author(s):  
Hamideh Amirfakhryan
Keyword(s):  
Clinical Trials ◽  
Data Extraction ◽  
Meta Analysis ◽  
Critical Issue ◽  
Financial Resource ◽  
Healthcare Decision ◽  
Middle Income ◽  
Middle Income Countries ◽  
Hierarchy Of Evidence ◽  
Healthcare Decision Making

There have always been challenges concerning tackling knowledge to practice. It is estimated that 85% of the investment in health research are wasted. Due to low quality, not all systematic review and meta-analysis are placed at the top of the hierarchy of evidence. Many individual clinical trials do not have the essential standards; therefore, conducting systematic reviews based on these low-quality individual studies is unreliable as they cannot be applied in healthcare decision-making and lead to resource waste. To overcome this great issue, several organizations have been worked hard to improve data extraction from only well-developed individual studies. However, it is not sufficient. It is time to stop and look back all years behind. It is time to reconsider our efforts to make the best conclusion in order to prohibit the huge waste of energy, time, and resources. The old viewpoint “the Beginning from the End” must be replaced with the new one “the Beginning from the Beginning”.  It means, we must do all struggles to conduct clinical trials in a standard high-quality format from the beginning as much as we could. Although, it does not seem easy, it might be possible by funding a high discipline, well-respected organization that is engaged in this critical issue. The supposed organization must define standards, flexible criteria for clinical trials, and all investigators must perform clinical trials under the supervision of this organization. Providing a considerable financial resource to grant the researches of the low- and middle-income countries to do clinical trials based on the designed protocol, considering an independent, high discipline journal for publishing well-conducted clinical trials regardless of their results, teaching researchers, considering another efficient policy to rank the journals rather than “impact factor” could help achieve this far-reach goal.

scholarly journals Equity in clinical trials for HIV-associated cryptococcal meningitis: A systematic review of global representation and inclusion of patients and researchers

2021 ◽  
Vol 15 (5) ◽  
pp. e0009376
Author(s):  
David S. Lawrence ◽  
Tshepo Leeme ◽  
Mosepele Mosepele ◽  
Thomas S. Harrison ◽  
Janet Seeley ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Cryptococcal Meningitis ◽  
Science Data ◽  
Middle Income ◽  
Representation Of Women ◽  
Middle Income Countries ◽  
Female Authors ◽  
Chi Squared ◽  
Global Representation

Background It is essential that clinical trial participants are representative of the population under investigation. Using HIV-associated cryptococcal meningitis (CM) as a case study, we conducted a systematic review of clinical trials to determine how inclusive and representative they were both in terms of the affected population and the involvement of local investigators. Methods We searched Medline, EMBASE, Cochrane, Africa-Wide, CINAHL Plus, and Web of Science. Data were extracted for 5 domains: study location and design, screening, participants, researchers, and funders. Data were summarised and compared over 3 time periods: pre-antiretroviral therapy (ART) (pre-2000), early ART (2000 to 2009), and established ART (post-2010) using chi-squared and chi-squared for trend. Comparisons were made with global disease burden estimates and a composite reference derived from observational studies. Results Thirty-nine trials published between 1990 and 2019 were included. Earlier studies were predominantly conducted in high-income countries (HICs) and recent studies in low- and middle-income countries (LMICs). Most recent studies occurred in high CM incidence countries, but some highly affected countries have not hosted trials. The sex and ART status of participants matched those of the general CM population. Patients with reduced consciousness and those suffering a CM relapse were underrepresented. Authorship had poor representation of women (29% of all authors), particularly as first and final authors. Compared to trials conducted in HICs, trials conducted in LMICs were more likely to include female authors (32% versus 20% p = 0.014) but less likely to have authors resident in (75% versus 100%, p < 0.001) or nationals (61% versus 93%, p < 0.001) of the trial location. Conclusions There has been a marked shift in CM trials over the course of the HIV epidemic. Trials are primarily performed in locations and populations that reflect the burden of disease, but severe and relapse cases are underrepresented. Most CM trials now take place in LMICs, but the research is primarily funded and led by individuals and institutions from HICs.

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