Health Research Policy and Systems最新文献

{"title":"The EU project Real4Reg: unlocking real-world data with AI.","authors":"Jonas Peltner, Cornelia Becker, Julia Wicherski, Silja Wortberg, Mohamed Aborageh, Inês Costa, Vera Ehrenstein, Joana Fernandes, Steffen Heß, Erzsébet Horváth-Puhó, Monika Roberta Korcinska Handest, Manuel Lentzen, Peggy Maguire, Niels Henrik Meedom, Rebecca Moore, Vanessa Moore, Dávid Nagy, Hillary McNamara, Anne Paakinaho, Kerstin Pfeifer, Liisa Pylkkänen, Blair Rajamaki, Evy Reviers, Christoph Röthlein, Martin Russek, Célia Silva, Dirk De Valck, Thuan Vo, Elvira Bräuner, Holger Fröhlich, Cláudia Furtado, Sirpa Hartikainen, Aleksi Kallio, Anna-Maija Tolppanen, Britta Haenisch","doi":"10.1186/s12961-025-01287-y","DOIUrl":"10.1186/s12961-025-01287-y","url":null,"abstract":"<p><strong>Background: </strong>The use of real-world data is established in post-authorization regulatory processes such as pharmacovigilance of drugs and medical devices, but is still frequently challenged in the pre-authorization phase of medicinal products. In addition, the use of real-world data, even in post-authorization steps, is constrained by the availability and heterogeneity of real-world data and by challenges in analysing data from different settings and sources. Moreover, there are emerging opportunities in the use of artificial intelligence in healthcare research, but also a lack of knowledge on its appropriate application to heterogeneous real-world data sources to increase evidentiary value in the regulatory decision-making and health technology assessment context.</p><p><strong>Methods: </strong>The Real4Reg project aims to enable the use of real-world data by developing user-friendly solutions for the data analytical needs of health regulatory and health technology assessment bodies across the European Union. These include artificial intelligence algorithms for the effective analysis of real-world data in regulatory decision-making and health technology assessment. The project aims to investigate the value of real-world data from different sources to generate high-quality, accessible, population-based information relevant along the product life cycle. A total of four use cases are used to provide good practice examples for analyses of real-world data for the evaluation and pre-authorization stage, the improvement of methods for external validity in observational data, for post-authorization safety studies and comparative effectiveness using real-world data. This position paper introduces the objectives and structure of the Real4Reg project and discusses its important role in the context of existing European projects focussing on real-world data.</p><p><strong>Discussion: </strong>Real4Reg focusses on the identification and description of benefits and risks of new and optimized methods in real-world data analysis including aspects of safety, effectiveness, interoperability, appropriateness, accessibility, comparative value creation and sustainability. The project's results will support better decision-making about medicines and benefit patients' health. Trial registration Real4Reg is registered in the HMA-EMA Catalogues of real-world data sources and studies (EU PAS number EUPAS105544).</p>","PeriodicalId":12870,"journal":{"name":"Health Research Policy and Systems","volume":"23 1","pages":"27"},"PeriodicalIF":3.6,"publicationDate":"2025-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11869640/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143523189","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Optimizing patient autonomy: a discrete choice experiment on preferences and disparities in healthcare provider selection.","authors":"Gideon Leibner, Shuli Brammli-Greenberg","doi":"10.1186/s12961-025-01296-x","DOIUrl":"10.1186/s12961-025-01296-x","url":null,"abstract":"<p><strong>Background: </strong>In 2023, Israel introduced a legislative reform that, according to the Israeli Ministry of Health, aims to improve transparency and expand options for healthcare providers. This reform seeks to enhance patient choice, improve service quality and accessibility, foster competition and strengthen the public health system. The goals also include empowering patients to fully exercise their rights and make more informed healthcare decisions.</p><p><strong>Objectives: </strong>This study explores public preferences regarding hospital choice before the 2023 reform, evaluates the relative importance of key hospital attributes influencing decision-making, assuming a baseline of high-quality care and analyses how these preferences vary across demographic and socio-economic groups.</p><p><strong>Methods: </strong>Utilizing a discrete choice experiment involving 2117 participants, this study quantifies preferences for different hospital attributes, including hospital type, geographical location, and appointment availability. The study design incorporates attributes identified through a literature review and expert interviews, optimized to estimate trade-offs between attribute levels.</p><p><strong>Results: </strong>Findings indicate a strong preference for shorter waiting times and proximity to specialized services. Significant disparities emerge among respondents, particularly between those with public versus additional voluntary insurance coverage and across population groups (i.e. Arabs and Jews). A notable proportion of Arab respondents preferred the existing hospital choice regime over any suggested attribute combinations.</p><p><strong>Conclusions: </strong>While legislative reforms are designed to enhance patient involvement in decision-making, substantial gaps remain between policy intentions and actual public preferences. Although increased autonomy and choice empower patients, they can also introduce challenges, such as decision fatigue and the consumer paradox, potentially undermining reform effectiveness. Our findings underscore the need for more nuanced, patient-centred health policy approaches. Future research should focus on strategies that better address the diverse needs and preferences of the population, ultimately enhancing healthcare system efficiency and equity.</p>","PeriodicalId":12870,"journal":{"name":"Health Research Policy and Systems","volume":"23 1","pages":"26"},"PeriodicalIF":3.6,"publicationDate":"2025-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11866801/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143515421","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Consumer and community involvement: implementation research for impact (CCIRI) - implementing evidence-based patient and public involvement across health and medical research in Australia - a mixed methods protocol.","authors":"Ashley H Ng, Sandra Reeder, Angela Jones, Ainslie Cahill, Debra Langridge, Susanne Baker, Leah Heiss, Alan Dorin, Helena Teede","doi":"10.1186/s12961-025-01293-0","DOIUrl":"10.1186/s12961-025-01293-0","url":null,"abstract":"<p><strong>Background: </strong>Within Australia, there is increasing recognition of the importance and value of patient and public involvement, or consumer and community involvement (CCI), in health and medical research and healthcare improvement. Despite this and policy mandates, there has been little behavioural and systems change to embed and support CCI. Often, this is relegated to tokenistic gestures rather than authentic partnerships. The aim of this national project is to use evidence-generated knowledge co-led by consumers, community members, researchers and clinicians to embed CCI in health and medical research and healthcare improvement.</p><p><strong>Methods: </strong>The Consolidated Framework for Implementation Research and the Learning Health System framework underpin the project to facilitate an iterative process to change systems and individual behaviour towards adoption of CCI in health and medical research and healthcare improvement. Key stakeholder groups include research translation centres, funding bodies, clinicians, professional staff involved in healthcare improvement, researchers and consumers and community members. To understand the attitudes, knowledge, beliefs, behaviours, system barriers and facilitators around CCI in health and medical research and healthcare improvement, semi-structured interviews and surveys will be conducted across key stakeholder groups. Template analysis and descriptive statistics will be used to report data from the national survey respectively prior to triangulation of data. Findings will be reported through traditional scientific outputs such as conference presentations and peer-reviewed publications. Other anticipated outputs include policy briefs, organizational implementation toolkits and resources and a co-designed digital knowledge hub to support individuals with implementation and scale up across stakeholders.</p><p><strong>Discussion: </strong>This study will build on considerable stakeholder engagement and prior priority-setting and includes broad and detailed consideration of perspectives from diverse stakeholders at a national level. Robust methodological frameworks, co-design and partnership with stakeholders will be used to inform resources to support systems change to facilitate CCI in health and medical research and healthcare improvement. Ethics approval was obtained from Monash Health (RES-23-0000-275Q).</p>","PeriodicalId":12870,"journal":{"name":"Health Research Policy and Systems","volume":"23 1","pages":"25"},"PeriodicalIF":3.6,"publicationDate":"2025-02-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11849185/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143491692","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A mixed-methods model for healthcare system responsiveness to public health: insights from Iranian experts.","authors":"Hooman Khanpoor, Ahad Alizadeh, Omid Khosravizadeh, Mohammad Amerzadeh, Sima Rafiei","doi":"10.1186/s12961-025-01295-y","DOIUrl":"10.1186/s12961-025-01295-y","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Responsiveness is a critical dimension of public health, focussing on how health systems address the needs, preferences and expectations of the population. It plays a central role in improving and maintaining the population's health by ensuring timely, equitable and patient-centred healthcare services.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;In this study, we developed a mixed-methods model to assess healthcare system responsiveness from a public health perspective, integrating the insights of Iranian experts. The model identifies key factors such as intersectoral collaboration, health equity and community partnerships, which are essential for enhancing system responsiveness and ultimately improving health outcomes.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Method: &lt;/strong&gt;In this study, conducted in 2024, we developed a mixed-methods model for assessing healthcare system responsiveness from a public health perspective, integrating the insights of Iranian experts. R software version 3.2.4 and the lavaan package were used for statistical analysis, considering the significance level of 0.05.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;On the basis of the literature review, the main components of health systems' responsiveness in the public health domain were extracted. The qualitative content analysis induced three different themes that affect health, which included payment mechanism (two subcategories of budget and incentive system), social determinants of health (three subcategories of intersectoral collaboration, community partnership and equity in health) and quality (three subcategories of timely provision of healthcare services, need-based service delivery and continuity of care). Finally, using structural equation modelling (SEM), a system of variables with causal relationships was developed. We found a statistically significant direct effect on intersectoral collaboration, health equity, payment mechanisms, timely delivery of services and need-based service provision. The strongest association was found for the payment system (β = 1.023, P ≤ 0.05). Model fit indices showed adequate fit.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Our developed model underscores the need for a comprehensive approach to healthcare system responsiveness, particularly focussing on public health services as foundational strategies for achieving universal health coverage. The results of our study revealed that a well-structured payment system and incentive mechanisms are critical for motivating healthcare professionals to deliver high-quality, timely and need-based services, ensuring sustainability in care provision. Beyond financial incentives, our model highlights the importance of health equity, intersectoral collaboration and community partnerships, which were identified as key drivers of responsiveness in healthcare systems. The findings indicate that fostering these elements not only strengthens healthcare delivery, but also supports the adaptation of services to meet diverse p","PeriodicalId":12870,"journal":{"name":"Health Research Policy and Systems","volume":"23 1","pages":"24"},"PeriodicalIF":3.6,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11844089/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143472452","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Inclusive health for people with disabilities in Chile: a national health system assessment.","authors":"Danae Rodríguez Gatta, Constanza Piriz Tapia, Elvira Tagle Schmidt, Jimena Luna Benavides, Daniel Vivar Jara, Rodrigo Moreno Celis, Gonzalo Tobar Carrizo, Judit Vilaró Cáceres, Phyllis Heydt, Lena Morgon Banks, Hannah Kuper","doi":"10.1186/s12961-024-01241-4","DOIUrl":"10.1186/s12961-024-01241-4","url":null,"abstract":"<p><strong>Background: </strong>Globally, one in six people have disabilities. They often experience health inequities and many of them arise from system-level failures. This study aimed to assess the inclusion of people with disabilities in the health system of Chile and define recommendations for improvement on the basis of the evidence.</p><p><strong>Methods: </strong>A health system assessment was conducted between June and November 2023 following the Missing Billion Disability-Inclusive Health Systems Framework and System Level Assessment Toolkit. The assessment was led by the Ministry of Health and conducted by a task team, including organizations of people with disabilities. Mixed methods were used to collect data on nine system-level and service delivery components for a set of 33 indicators, including through a health policy review, systematic review, key informant interviews and a scoping review. Scores were assigned to indicators, components and the overall health system. With this assessment, key recommendations were developed and agreed upon on the basis of a prioritization analysis of impact and feasibility during workshops.</p><p><strong>Results: </strong>The Chilean health system was assessed to have a low progress towards disability-inclusive health. Among system-level components, intermediate progress has been made in governance, health financing and data and evidence. However, progress in leadership on disability seems low. Among service delivery components, the accessibility of health facilities and rehabilitation and assistive technology showed the best results. However, there were notable gaps in the autonomy and awareness and ability to afford care by people with disabilities, and the capacity of human resources to support this group. The task team defined priority actions in governance, leadership, and human resources.</p><p><strong>Conclusions: </strong>Short-term actions for the country should involve foundational governance on inclusive health, strengthened leadership of people with disabilities, and mandatory training of healthcare workers to improve healthcare access among this population. Future reassessments should be conducted to monitor and evaluate progress on effective healthcare coverage and health status among people with disabilities.</p>","PeriodicalId":12870,"journal":{"name":"Health Research Policy and Systems","volume":"23 1","pages":"22"},"PeriodicalIF":3.6,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11843747/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143467759","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Co-designing an intervention for cardiovascular disease risk assessment and management after hypertensive disorders of pregnancy in primary care.","authors":"Kaylee Slater, Rachael Taylor, Karen McLaughlin, Craig E Pennell, Karyn Forbes, Milena Marcetic, Clare E Collins, Melinda Hutchesson","doi":"10.1186/s12961-024-01269-6","DOIUrl":"10.1186/s12961-024-01269-6","url":null,"abstract":"<p><strong>Background: </strong>Women with a history of hypertensive disorders of pregnancy are at an increased risk of cardiovascular disease. Although clinical practice guidelines for management of hypertensive disorders of pregnancy recommend involvement of a general practitioner for ongoing cardiovascular disease preventative care, there are no intervention strategies embedded within primary care aimed at improving risk assessment or management for women after hypertensive disorders of pregnancy. The study aim was to co-design an intervention to improve implementation of cardiovascular disease risk assessment and management following hypertensive disorders of pregnancy for primary care settings in a local health district in New South Wales, Australia.</p><p><strong>Method: </strong>Using the Integrated Knowledge Translation framework, a series of five co-design meetings with the investigative team and end users were conducted online. Meetings were informed by the Behaviour Change Wheel framework for intervention development and incorporated research findings from a systematic review and meta-analysis, surveys and an online discussion. Data from activities and audio recordings following each meeting were analysed thematically using inductive-deductive thematic analysis. Results were summarized after each meeting, and findings used to inform ongoing intervention development.</p><p><strong>Results: </strong>The 18 end users included women with lived experience of hypertensive disorders of pregnancy (n = 8), obstetricians (n = 2), midwives (n = 5) and general practitioners (n = 3). Target priorities were to improve communication between hospital staff and general practitioners following the occurrence of hypertensive disorders of pregnancy and increase the knowledge of general practitioners and women regarding cardiovascular disease prevention after cardiometabolic pregnancy complications. Part 1 of the intervention is set within the hospital setting and delivered via physical resources to address the communication gap between hospital and primary care providers about the occurrence of hypertensive disorders of pregnancy. Part 2 is delivered via an update to an existing general practice education platform and through resources for use within consultations to provide education for women and general practitioners about cardiovascular disease prevention after hypertensive disorders of pregnancy.</p><p><strong>Conclusion: </strong>The Integrated Knowledge Translation and Behaviour Change Wheel frameworks aided in the development of a targeted intervention to improve implementation of cardiovascular risk assessment and management for women after hypertensive disorders of pregnancy, based on gaps identified in current primary care practice.</p>","PeriodicalId":12870,"journal":{"name":"Health Research Policy and Systems","volume":"23 1","pages":"23"},"PeriodicalIF":3.6,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11844034/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143467824","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Towards a learning healthcare community in the Bronx: evaluating the Bridging Research, Accurate Information and Dialogue (BRAID) model.","authors":"Sarah M McNeilly, Katherine W Wang, Sarah A Jacobs, Nang S Yone, Debra A Williams, Bruce D Rapkin, Caroline Davis Joseph, Damara N Gutnick","doi":"10.1186/s12961-025-01289-w","DOIUrl":"10.1186/s12961-025-01289-w","url":null,"abstract":"<p><strong>Background: </strong>Learning healthcare communities (LHCCs) have been proposed as a next-generation evolution of learning health systems that can advance health equity; however, a practical mechanism for enabling the active and continuous community engagement required for one has not yet been described in the literature. Recognizing that community-based participatory research (CBPR) could potentially meet this need, a team at the Montefiore Medical Center/Albert Einstein College of Medicine designed a novel evidence-based CBPR model - Bridging Research, Accurate Information and Dialogue (BRAID) - that initiates meaningful, longitudinal dialogues to foster bidirectional trust between researchers, clinicians, scientists and communities.</p><p><strong>Methods: </strong>A mixed-methods cohort study of two BRAID cohorts was conducted between 2022 and 2023. Eligible participants were recruited from the Bronx, New York, United States and convened in a series of conversation circles. Multimodal data was collected from all participants, including quantitative pre- and post-series surveys and same-day conversation circle feedback forms. Surveys were administered using SurveyMonkey and descriptive statistics were completed in Excel and SPSS.</p><p><strong>Results: </strong>A total of 42 participants were enrolled, most of whom were people of colour who had not participated in research before. Among them, 40 participants provided at least one response to a same-day conversation circle feedback form, which reflected consistently positive experiences with BRAID. This was consistent with evidence from the post-series survey, in which every one of the 36 respondents stated that they would either definitely (83.3%, N = 30/36) or probably (16.7%, N = 6/36) recommend participation in BRAID to someone like them. Of note, 91.7% (N = 33/36) had already disseminated health information learned through BRAID downstream and 84.4% (N = 27/32) indicated that BRAID strengthened their trust in science and research, highlighting unique and distinguishing features of the model.</p><p><strong>Conclusions: </strong>Our quantitative evidence suggests that BRAID is effective, efficient and scalable, with experiential evidence supporting that it is reproducible. These factors suggest that BRAID implementation can facilitate rapid, bidirectional information sharing that builds trust between healthcare organizations and communities. This has laid the groundwork for an LHCC in the Bronx, with the potential to be adopted by healthcare organizations elsewhere.</p>","PeriodicalId":12870,"journal":{"name":"Health Research Policy and Systems","volume":"23 1","pages":"20"},"PeriodicalIF":3.6,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11837684/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143457596","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Making intersectoral stakeholder engagement in medicine quality research work: lessons from the STARmeds study in Indonesia.","authors":"Amalia Hasnida, Roland Bal, Reise Manninda, Stanley Saputra, Yunita Nugrahani, Faradiba Faradiba, Maarten Olivier Kok","doi":"10.1186/s12961-025-01286-z","DOIUrl":"10.1186/s12961-025-01286-z","url":null,"abstract":"<p><strong>Background: </strong>Tackling falsified and substandard medicines requires intersectoral collaboration, impact-oriented research and the effective application of research findings. However, the best way to organize research and involve stakeholders from different sectors to ensure that results are used, remains unclear. We aimed to assess how intersectoral stakeholder engagement in research on medicine quality in Indonesia evolved, influenced the research processes and participants, and affected the uptake of the results.</p><p><strong>Methods: </strong>For this prospective case study, we adopted an abductive approach inspired by contribution mapping and collaborative governance. We conducted 37 interviews with key informants, observed 24 meetings and analysed 121 documents to systematically map the engagement of stakeholders in a study on medicine quality, focusing on processes, influences and research-related contributions.</p><p><strong>Results: </strong>From the outset, it proved feasible, but challenging, to effectively engage stakeholders in research into falsified and substandard medicines in Indonesia. After a cautious start and persistent efforts, stakeholders, such as the national medicine regulatory authority, became increasingly involved and developed a shared understanding of the need for intersectoral collaboration to tackle problems with medicine quality. While the research findings did not lead to a different estimate of the magnitude of the problem, the involvement of stakeholders was beneficial. After formalizing the collaboration, stakeholders provided data needed to study potential risk factors, product varieties and sales volumes, and contributed to decisions during the research and interpretation of the findings. Owing to frequent personnel changes and diverging priorities, stakeholder engagement required more effort than anticipated, and necessitated a strategic and adaptive approach. This approach had to account for the varying priorities and interests of stakeholders, the evolving framing of the problem, the implications of the findings and the nature of the field, where regulators must operate cautiously, balance interests and respond to critical incidents.</p><p><strong>Conclusions: </strong>Intersectoral stakeholder engagement in medicine quality research is challenging but beneficial. Engagement contributed to building trust and relationships between researchers and stakeholders, helped forge an intersectoral network focused on medicine quality, exposed the medicine regulator to new methods, inspired stakeholders to take on new roles and make better use of existing data and furthered a research-policy partnership forum on pharmaceutical topics.</p>","PeriodicalId":12870,"journal":{"name":"Health Research Policy and Systems","volume":"23 1","pages":"21"},"PeriodicalIF":3.6,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11840975/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143457583","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical trial registration in India: 12% of drug regulatory trials are not registered, as required by law.","authors":"Adithi Gopadi Ravindranath, Albin Benny, Iqbal S Bhalla, Ravi Vaswani, Gayatri Saberwal","doi":"10.1186/s12961-025-01288-x","DOIUrl":"10.1186/s12961-025-01288-x","url":null,"abstract":"<p><strong>Background: </strong>Amongst other things, the drug regulator, Central Drugs Standard Control Organization (CDSCO), is responsible for regulating clinical trials that underlie drug approvals in India. Since 2009, CDSCO has mandated that all regulatory clinical trials be registered with the Clinical Trials Registry - India (CTRI). In this study, we aimed to determine whether regulatory trials, for which CDSCO had given permission, were registered with CTRI as required. We also aimed to quantify missing CTRI records, if any.</p><p><strong>Methods: </strong>This study involved regulatory trials, for which CDSCO permission letters were available. The permission letters, available as portable document format (PDF) files, were analysed to extract trial titles and protocol numbers. These data were then used to search the CTRI database, which was initially downloaded on 19 January 2024 and updated in August 2024, for matching records. The matches were confirmed by cross-referencing titles and protocol numbers, ignoring protocol version variations.</p><p><strong>Results: </strong>Of the 381 trials examined, 335 (88%) had corresponding CTRI records, whereas 46 (12%) did not.</p><p><strong>Conclusions: </strong>This study highlights that not all regulatory trials approved by CDSCO are registered with CTRI, despite legal requirements. The absence of a significant number of trials from CTRI raises concerns about transparency in the clinical trial enterprise in India. To improve trust and regulatory compliance, it is essential to establish explicit linkages between CDSCO and CTRI records to avoid the challenges of identifying matches. This study contributes to ongoing efforts to increase transparency and accountability in clinical trial registration in India.</p>","PeriodicalId":12870,"journal":{"name":"Health Research Policy and Systems","volume":"23 1","pages":"19"},"PeriodicalIF":3.6,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11834549/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143448488","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A scoping review of the roles of stakeholders and coordination mechanisms for enhanced multi-sectoral and multi-level interventions in COVID-19 response in Nigeria.","authors":"Uchenna Ezenwaka, Chinyere Mbachu, Obinna Onwujekwe","doi":"10.1186/s12961-024-01276-7","DOIUrl":"10.1186/s12961-024-01276-7","url":null,"abstract":"<p><strong>Background: </strong>Collaboration among multiple stakeholders from different sectors requires a coherent coordination mechanism in implementing responses to public health emergencies such as coronavirus disease 2019 (COVID-19) to improve the effectiveness and efficiency of countermeasures against the pandemic. The paper describes multi-stakeholder roles and the coordination mechanisms that were used at different levels of government in the COVID-19 response in Nigeria.</p><p><strong>Methods: </strong>A scoping review of documents on COVID-19 was undertaken between March 2021 and October 2022. Databases including Google Scholar, PubMed, Medline and Google were searched using \"COVID-19\", \"Nigeria\", \"response\" and \"government\" as the keywords. We included articles published from 30 January 2020 to 1 October 2022. The literature was extracted into Excel spreadsheets and analysed using the adapted WHO framework for multi-stakeholder preparedness coordination.</p><p><strong>Results: </strong>A total of 173 documents were reviewed. The review revealed that various stakeholders (state and non-state actors) at national and sub-national levels played complementary roles in the implementation of different countermeasures to COVID-19 in Nigeria. The multi-sectoral response to COVID-19 in Nigeria was coordinated through the Presidential and State Task Force Teams. However, there were very weak linkages between and across different task forces. In addition, the expert and advisory committees at national and sub-national levels apparently functioned independently without lines of communication amongst them to encourage information sharing and learning. More so, the processes of coordination of different actors and their activities were fragmented and constrained by poor communication of policies among stakeholders, poor planning and contextualization of response strategies, lack of data for evidence-informed planning and lack of accountability.</p><p><strong>Conclusions: </strong>The coordination of multi-stakeholders and multi-sectoral response to COVID-19 at national and sub-national levels in Nigeria was weak. A systematic coordination framework involving multiple stakeholders working at varying capacities is needed for effective and efficient response during pandemics such as COVID-19, to reduce duplication of efforts, inequitable resource allocation and wastage of resources and time. It is recommended that a future systematic coordination framework and guidelines involve multiple stakeholders, including the private and non-health public sectors, working at varying capacities and levels, to ensure an effective and efficient response during pandemics.</p>","PeriodicalId":12870,"journal":{"name":"Health Research Policy and Systems","volume":"23 1","pages":"18"},"PeriodicalIF":3.6,"publicationDate":"2025-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11808979/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143390358","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}