Revista panamericana de salud pública = Pan American journal of public health
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Rev. Panam. Salud Publica · Jun 2015
Regulatory transparency: social, technical, and ethical aspects of clinical trial data access.
In the field of health regulation, enabling public access to data from clinical trials is a process currently undergoing consolidation by the principal regulators worldwide. This paper discusses recent developments in public policy regarding regulatory transparency, and the risks and benefits of a regulatory impact-analysis on clinical trial reports, from the perspective of the key stakeholders (i.e., patients, prescribers, government, society, industry, and regulators). Additionally, the social, technical, and ethical aspects of the datasharing process are highlighted, including access limits, commercially-confidential data and patent rights, privacy of research subjects, arrangements and publicity tools, and clinical trials registration. Furthermore, perspectives on improvement and expansion of regulatory transparency policies are presented, contextualizing North American, Latin American, and European experiences, and highlighting in-teragency cooperation and collaboration initiatives that aim to harmonize health programs and regulatory convergence.
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Rev. Panam. Salud Publica · Jun 2015
Moving toward universal access to health and universal health coverage: a review of comprehensive primary health care in Suriname.
To provide an overview of comprehensive primary health care (CPHC) development and implementation in Suriname in peer-reviewed literature. ⋯ Given the focus on primary health care in the Americas and the notable developments that have occurred in Surinamese health policy and health care, particularly in health care reform, the paucity of published research on CPHC in Suriname was an unexpected finding that may be partly due to prioritizing research on disease control rather than health policy and systems research. The limited amount of scientific literature on this topic 1) prevents clear understanding of CPHC development and implementation in Suriname and 2) underscores the need to strengthen the national health research system to better inform policies for moving the country toward universal health access and coverage to improve the health of all of its citizens.