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INTRODUCTION: The universal health research ethical principles must be adhered to ensure a balance between science and safeguarding participants' rights, safety and dignity. A cross-sectional study was conducted to assess the knowledge, attitude, and practice of research ethics among researchers in Nepal. METHODS: The study was carried out among 449 researchers who submitted proposals for ethical review and approval from the Ethical Review Board of the Nepal Health Research Council between January 2017 to August 2021. Simple random sampling was done ensuring a proportional representation of researchers from all areas of health research. A structured questionnaire was administered online for data collection. RESULTS: The participants aged between 23-80 years old consented to complete the survey questionnaire. The median age of the respondents was 35 (23-80) years. Among all the respondents, 52 (11.58%) were unaware about the National Ethical Guideline for Health Research. Similarly, 110 (24.50%) respondents strongly agreed that the ethical review process impairs research and makes it harder for researchers to conduct research; 372 (82.85%) respondents had pursued research activity only after obtaining ethical approval. CONCLUSIONS: Half of the respondents had knowledge on different aspects of research ethics.
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Ética em Pesquisa , Conhecimentos, Atitudes e Prática em Saúde , Pesquisadores , Humanos , Nepal , Adulto , Pessoa de Meia-Idade , Estudos Transversais , Masculino , Feminino , Idoso , Pesquisadores/ética , Inquéritos e Questionários , Adulto Jovem , Idoso de 80 Anos ou mais , Pesquisa Biomédica/éticaRESUMO
Clinical research is conducted to investigate physicians' clinical questions and to clarify research hypotheses. When conducting clinical research, it is important to carefully consider the research design in advance. An optimal design that meets the objectives of the study and addresses practical implementation issues is desirable. Randomized comparisons during the final confirmatory phase may be the best tool for comparing treatments. However, not all clinical questions can be answered through randomized controlled trials. This article summarizes the basics of clinical study design and explains the role of randomization. It also introduces a propensity score-based method that has gained attention as a statistical method for comparing treatment groups when randomization is not feasible, and is increasingly being utilized in clinical research.
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Projetos de Pesquisa , Humanos , Pesquisa Biomédica , Ensaios Clínicos Controlados Aleatórios como Assunto , Pontuação de PropensãoRESUMO
Cancer is the second leading cause of death in North Carolina and approximately half of cancers are diagnosed in older adults (≥65 years). Cancer clinical trials in older adults are limited and there is a lack of evidence on optimal care strategies in this population. We highlight how big data can fill in gaps in geriatric oncology research.
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Big Data , Geriatria , Oncologia , Neoplasias , Humanos , Idoso , North Carolina/epidemiologia , Neoplasias/terapia , Pesquisa BiomédicaRESUMO
AIMS: Economic studies have found that public support of basic medical research provides important long-term benefits. In response to suggestions that private pharmaceutical research and development (R&D) funding could be totally replaced by public funding, we investigate the economic implications of such a substitution in funding roles that maintain the recent pace of pharmaceutical innovation. MATERIALS AND METHODS: Total lifecycle R&D costs were estimated using the latest available R&D expenditures per novel molecule entering clinical trials, likelihood of approval, pre-clinical and post-approval expenditures, using a published survey and a review of publicly available financial accounts from US-listed multinational developers. This estimate was then stratified by the average number of annual FDA approvals to estimate total costs of R&D funding born by the private sector. RESULTS: We find total lifecycle R&D costs were US$2.83 billion per approved medicine. Estimated uncapitalized costs to replace private R&D funding for one year of FDA approvals were $139.6 billion. These additional costs are equivalent to 302% of the entire National Institute for Health 2022 budget of $46.2 billion, and around 25 times NIH's estimated annual $5.6 billion currently dedicated to clinical research trials for pharmaceuticals. Further assessing the policy proposition through a literature review, we found little evidence for improvements in economic efficiency via public funding substitution, while there may be additional challenges including asymmetric information, adverse selection, yardstick competition, hold-up, under-rewarding of incremental innovation and political rent-seeking. LIMITATIONS: Our calculations may undervalue full replacement costs, by excluding non-R&D expenses for manufacturing, distribution, or financing. CONCLUSIONS: The bulk of investment in R&D is underwritten by the private sector. Political discourse portraying the NIH as the central force in bringing a new drug to market may underappreciate the pivotal role of private at-risk capital. Replacing such investment while maintaining the current innovation output in terms of approved therapies would necessitate substantial increases in taxpayer financing.
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Setor Privado , Setor Público , Setor Público/economia , Setor Privado/economia , Estados Unidos , Humanos , Indústria Farmacêutica/economia , Apoio à Pesquisa como Assunto , Aprovação de Drogas , Pesquisa Biomédica/economia , Financiamento Governamental , Análise Custo-BenefícioRESUMO
The 2024 Mary Tyler Moore Vision Initiative (MTM Vision) Workshop on Data convened to discuss best practices and specific considerations for building a comprehensive, shareable MTM Vision data lake. The workshop aimed to accelerate the development of new indications, therapies, and regulatory pathways for diabetic retinal disease (DRD) by standardizing and harmonizing clinical data and ocular 'omics analyses. Standardization of data collection, the use of common data elements, and data interoperability were emphasized, alongside federated learning approaches to promote data sharing and collaboration while maintaining data privacy and security. The integration of molecular data with other multimodal data types was recognized as a promising strategy for leveraging machine learning and AI approaches to advancing therapeutics development and improving treatment outcomes for DRD patients. Partnerships with entities such as the National Eye Institute, part of the National Institutes of Health, foundations, and industry were deemed vital for the successful implementation of these initiatives.
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Retinopatia Diabética , Humanos , Retinopatia Diabética/terapia , Disseminação de Informação/métodos , Pesquisa Biomédica , Estados UnidosRESUMO
Bibliometric analyses are increasing in the field of gastric cancer. This letter discusses a recently published analysis that focused on the bidirectional relationship between depression and gastric cancer and evaluated the types of papers published in this field and the changes in the direction of research. There is an increasing need for new, clinically relevant studies of this association.
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Bibliometria , Depressão , Neoplasias Gástricas , Neoplasias Gástricas/psicologia , Neoplasias Gástricas/patologia , Humanos , Depressão/diagnóstico , Depressão/epidemiologia , Depressão/psicologia , Pesquisa Biomédica/tendências , Pesquisa Biomédica/estatística & dados numéricosRESUMO
BACKGROUND: Evidence-based research remains the cornerstone in changing the narrative of wholesome health among Adolescents and Young Adults Living with HIV (AYALHIV). However, little is known about the perceptions of AYALHIV in research participation and outcomes, in low- and middle-income countries, especially in sub-Saharan Africa. This study describes the perception of AYALHIV in research participation and outcome in Lagos, Nigeria. METHODS: The study population was drawn from a cohort of participants in a cross-sectional study at the Nigerian Institute of Medical Research. The survey questions were on perceptions of the importance of research participation, the frequency, understanding of participation in research, the interest in the outcome, the knowledge of the interpretation of the outcome and the willingness to participate in future studies. Data obtained was analyzed using SPSS version 26.0. RESULTS: The mean age of the AYALHIV was 15.7(±3.1) years, with a male-to-female ratio of (0.8:1), and 85.7% on antiretroviral drugs for at least five years. Seventy-two percent (46/63) have been involved in previous studies at least once, with only 27% (17/63) informed on the outcome of the research they have ever participated. Only 30% (19) of participants understood they were involved in research, with 92% interested in the study outcome. 87.3% (55) will request more information before participating in future research activities. CONCLUSION: Educating AYALHIV on research participation is important in promoting concerted efforts by researchers towards improving engagement, patient-centred care, and research dissemination.
CONTEXTE: La recherche fondée sur des données probantes reste la pierre angulaire du changement du discours sur la santé saine chez les adolescents et les jeunes adultes vivant avec le VIH (AYALHIV). Cependant, on sait peu de choses sur les perceptions de l'AYALHIV dans la participation et les résultats de la recherche, dans les pays à revenu faible et intermédiaire, en particulier en Afrique subsaharienne. Cette étude décrit la perception d'AYALHIV dans la participation et les résultats de la recherche à Lagos, au Nigéria. METHODES: La population m'étudiée a été tirée d'une cohorte de participants à une étude transversale menée à l'Institut nigérian de recherche médicale. Les questions de l'enquête portaient sur les perceptions de l'importance de la participation à la recherche, la fréquence, la compréhension de la participation à la recherche, l'intérêt pour les résultats, la connaissance de l'interprétation des résultats et la volonté de participer à des études futures. Les données obtenues ont été analysées à l'aide de SPSS version 26.0. RESULTATS: L'âge moyen des AYALHIV était de 15,7 (± 3,1) ans, avec un ratio hommes/femmes de (0,8 : 1) et 85,7 % prenaient des médicaments antirétroviraux depuis au moins cinq ans. Soixantedouze pour cent (46/63) ont participé à des études antérieures au moins une fois, et seulement 27 % (17/63) sont informés des résultats de la recherche à laquelle ils ont déjà participé. Seulement 30 % (19) des participants comprenaient qu'ils étaient impliqués dans la recherche, et 92 % d'entre eux étaient intéressés par les résultats de l'étude. 87,3 % (55) demanderont plus d'informations avant de participer à de futures activités de recherche. CONCLUSION: Éduquer AYALHIV sur la participation à la recherche est important pour promouvoir les efforts concertés des chercheurs en vue d'améliorer l'engagement, les soins centrés sur le patient et la diffusion de la recherche. MOTS CLES: VIH, Adolescent, Jeunes adultes, Perception, Recherche.
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Infecções por HIV , Humanos , Masculino , Nigéria , Feminino , Adolescente , Infecções por HIV/psicologia , Estudos Transversais , Adulto Jovem , Conhecimentos, Atitudes e Prática em Saúde , Inquéritos e Questionários , Pesquisa Biomédica , Participação do Paciente/métodos , AdultoRESUMO
Background: In the United States, Black and Latino children with asthma are more likely than White children with asthma to require emergency department visits or hospitalizations because of an asthma exacerbation. Although many cite patient-level socioeconomic status and access to health care as primary drivers of disparities, there is an emerging focus on a major root cause of disparities-systemic racism. Current conceptual models of asthma disparities depict the historical and current effects of systemic racism as the foundation for unequal exposures to social determinants of health, environmental exposures, epigenetic factors, and differential healthcare access and quality. These ultimately lead to biologic changes over the life course resulting in asthma morbidity and mortality. Methods: At the 2022 American Thoracic Society International Conference, a diverse panel of experts was assembled to identify gaps and opportunities to address systemic racism in childhood asthma research. Panelists found that to examine and address the impacts of systemic racism on children with asthma, researchers and medical systems that support biomedical research will need to 1) address the current gaps in our understanding of how to conceptualize and characterize the impacts of systemic racism on child health, 2) design research studies that leverage diverse disciplines and engage the communities affected by systemic racism in identifying and designing studies to evaluate interventions that address the racialized system that contributes to disparities in asthma health outcomes, and 3) address funding mechanisms and institutional research practices that will be needed to promote antiracism practices in research and its dissemination. Results: A thorough literature review and expert opinion discussion demonstrated that there are few studies in childhood asthma that identify systemic racism as a root cause of many of the disparities seen in children with asthma. Community engagement and participation in research studies is essential to design interventions to address the racialized system in which patients and families live. Dissemination and implementation studies with an equity lens will provide the multilevel evaluations required to understand the impacts of interventions to address systemic racism and the downstream impacts. To address the impacts of systemic racism and childhood asthma, there needs to be increased training for research teams, funding for studies addressing research that evaluates the impacts of racism, funding for diverse and multidisciplinary research teams including community members, and institutional and financial support of advocating for policy changes based on study findings. Conclusions: Innovative study design, new tools to identify the impacts of systemic racism, community engagement, and improved infrastructure and funding are all needed to support research that will address impacts of systemic racism on childhood asthma outcomes.