PDF(Pubmed)
Abstract：
UNASSIGNED: Medical research and development (R&D) is an undoubtedly relevant activity to drive innovation, improve healthcare policies and bring patients treatment opportunities for common and rare diseases. Equity and inclusion are matters of concern in research. High-income countries\' research teams are more likely to have more impactful publications, grant funding, and clinical trials than middle or low-income countries. Low budget allocations to R&D and existing gaps in regulatory frameworks are some obstacles to growth. This unvirtuous cycle results in scarce advances in common endemic diseases and the underrepresentation of specific populations in innovative therapeutics research.
UNASSIGNED: We conducted a policy review and qualitative research to determine the principal characteristics of basic and clinical medical research in Paraguay, as well as barriers and facilitators to improve innovative R&D strategies in this country. To this aim, we examined published articles from 2005 to 2020, the organizational structure of national research agencies, the current regulation framework, and the composition and experience of local research groups and ethical review boards (ERBs). In addition, we performed semi-structured interviews to evaluate perceptions and expectations from different stakeholders, including investigators, ERBs members, sponsor associates, and Regulatory Agency executive staff.
UNASSIGNED: In 2018, Paraguay ranked 10th out of 12 South American countries in total number of publications and cumulative h-index score. Total Gross Domestic Product (GDP) allocation for R&D was 0.15%, ranking eighth out of 12 in the region. In 2021, the number of trials registered on ClinicalTrials.gov was 52, with only 16 ongoing recruiting studies at that time.Some of the main barriers identified included low incentives for academic careers and lack of experience in pharmaceutical research. An emergent necessity to develop a straight- forward normative framework was detected. Main facilitators included the development of two research initiative programs (PRONII and PROCIENCIA) from CONACYT (National Council of Science and Technology) which were associated with higher budget allocation and total number of publications in the 2011 to 2017 period. A total of six stakeholders participated in the semi-structured surveys. Interviewees highlighted the necessity of a centralized policy to promote R&D, which incorporates investigators and ERBs training, the development of standardized procedures, and the dissemination of research activities. Sponsor associates underlined that real-world evidence may represent a distinctive opportunity to enhance local research.
UNASSIGNED: Coordinated efforts are needed to break the unvirtuous cycle. There is an increasing interest in enhancing health research in Paraguay, materialized in the creation of specific programs that encourage the collaborative work of healthcare providers, basic scientists, and private investors. Nonetheless, a comprehensive approach is needed also to strengthen regulatory agencies and attract external sponsorship. While modern and currently popular topics, including artificial intelligence, real-world data, and translational research may represent key opportunities to seek investment, special policies should be adopted to prioritize research on the determinants of health in the Paraguayan population.
UNASSIGNED: We conducted a policy review and qualitative research to determine the principal characteristics of basic and clinical medical research in Paraguay, as well as barriers and facilitators to improve innovative R&D strategies in this country. To this aim, we examined published articles from 2005 to 2020, the organizational structure of national research agencies, the current regulation framework, and the composition and experience of local research groups and ethical review boards (ERBs). In addition, we performed semi-structured interviews to evaluate perceptions and expectations from different stakeholders, including investigators, ERBs members, sponsor associates, and Regulatory Agency executive staff.
UNASSIGNED: In 2018, Paraguay ranked 10th out of 12 South American countries in total number of publications and cumulative h-index score. Total Gross Domestic Product (GDP) allocation for R&D was 0.15%, ranking eighth out of 12 in the region. In 2021, the number of trials registered on ClinicalTrials.gov was 52, with only 16 ongoing recruiting studies at that time.Some of the main barriers identified included low incentives for academic careers and lack of experience in pharmaceutical research. An emergent necessity to develop a straight- forward normative framework was detected. Main facilitators included the development of two research initiative programs (PRONII and PROCIENCIA) from CONACYT (National Council of Science and Technology) which were associated with higher budget allocation and total number of publications in the 2011 to 2017 period. A total of six stakeholders participated in the semi-structured surveys. Interviewees highlighted the necessity of a centralized policy to promote R&D, which incorporates investigators and ERBs training, the development of standardized procedures, and the dissemination of research activities. Sponsor associates underlined that real-world evidence may represent a distinctive opportunity to enhance local research.
UNASSIGNED: Coordinated efforts are needed to break the unvirtuous cycle. There is an increasing interest in enhancing health research in Paraguay, materialized in the creation of specific programs that encourage the collaborative work of healthcare providers, basic scientists, and private investors. Nonetheless, a comprehensive approach is needed also to strengthen regulatory agencies and attract external sponsorship. While modern and currently popular topics, including artificial intelligence, real-world data, and translational research may represent key opportunities to seek investment, special policies should be adopted to prioritize research on the determinants of health in the Paraguayan population.
摘要：
■医学研究与开发（R＆D）无疑是推动创新的相关活动，改善医疗保健政策，为患者提供常见和罕见疾病的治疗机会。公平和包容是研究中关注的问题。高收入国家的研究团队更有可能拥有更有影响力的出版物，赠款资金，和临床试验比中等或低收入国家。研发预算拨款低和监管框架中的现有差距是增长的一些障碍。这种不良循环导致常见地方病的进展很少，并且在创新疗法研究中特定人群的代表性不足。
■我们进行了政策审查和定性研究，以确定巴拉圭基础和临床医学研究的主要特征，以及改善该国创新研发战略的障碍和促进者。为了这个目标,我们研究了2005年至2020年发表的文章，国家研究机构的组织结构，当前的监管框架，以及当地研究小组和伦理审查委员会(ERB)的组成和经验。此外,我们进行了半结构化访谈，以评估不同利益相关者的看法和期望，包括调查人员,ERB成员，赞助商合伙人,和监管机构执行人员。
■2018年，巴拉圭在12个南美国家的出版物总数和累计h指数得分中排名第10。用于研发的国内生产总值(GDP)拨款总额为0.15%，在该地区12人中排名第八。2021年，在ClinicalTrials.gov上注册的试验数量为52项，当时只有16项正在进行招募研究。确定的一些主要障碍包括对学术职业的低激励和缺乏药物研究经验。人们发现迫切需要开发一个直接的规范框架。主要促进者包括来自CONACYT（国家科学技术委员会）的两个研究计划（PRONII和PROCIENCIA）的开发，这与2011年至2017年期间更高的预算拨款和出版物总数有关。共有六个利益攸关方参加了半结构化调查。受访者强调了促进研发的集中化政策的必要性，其中包括调查人员和ERB培训，制定标准化程序，以及研究活动的传播。赞助商同事强调，现实世界的证据可能代表了加强本地研究的独特机会。
■需要协调努力来打破这种不良性循环。巴拉圭对加强健康研究的兴趣日益浓厚，体现在创建鼓励医疗保健提供者协同工作的具体计划中，基础科学家，私人投资者。尽管如此，还需要采取全面的方法来加强监管机构并吸引外部赞助。虽然现代和当前流行的话题，包括人工智能，真实世界的数据，转化研究可能代表寻求投资的关键机会，应采取特殊政策，优先研究巴拉圭人口的健康决定因素。
■我们进行了政策审查和定性研究，以确定巴拉圭基础和临床医学研究的主要特征，以及改善该国创新研发战略的障碍和促进者。为了这个目标,我们研究了2005年至2020年发表的文章，国家研究机构的组织结构，当前的监管框架，以及当地研究小组和伦理审查委员会(ERB)的组成和经验。此外,我们进行了半结构化访谈，以评估不同利益相关者的看法和期望，包括调查人员,ERB成员，赞助商合伙人,和监管机构执行人员。
■2018年，巴拉圭在12个南美国家的出版物总数和累计h指数得分中排名第10。用于研发的国内生产总值(GDP)拨款总额为0.15%，在该地区12人中排名第八。2021年，在ClinicalTrials.gov上注册的试验数量为52项，当时只有16项正在进行招募研究。确定的一些主要障碍包括对学术职业的低激励和缺乏药物研究经验。人们发现迫切需要开发一个直接的规范框架。主要促进者包括来自CONACYT（国家科学技术委员会）的两个研究计划（PRONII和PROCIENCIA）的开发，这与2011年至2017年期间更高的预算拨款和出版物总数有关。共有六个利益攸关方参加了半结构化调查。受访者强调了促进研发的集中化政策的必要性，其中包括调查人员和ERB培训，制定标准化程序，以及研究活动的传播。赞助商同事强调，现实世界的证据可能代表了加强本地研究的独特机会。
■需要协调努力来打破这种不良性循环。巴拉圭对加强健康研究的兴趣日益浓厚，体现在创建鼓励医疗保健提供者协同工作的具体计划中，基础科学家，私人投资者。尽管如此，还需要采取全面的方法来加强监管机构并吸引外部赞助。虽然现代和当前流行的话题，包括人工智能，真实世界的数据，转化研究可能代表寻求投资的关键机会，应采取特殊政策，优先研究巴拉圭人口的健康决定因素。
