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1.
Heliyon ; 10(14): e34662, 2024 Jul 30.
Artigo em Inglês | MEDLINE | ID: mdl-39149074

RESUMO

According to United Nations projections, future global urban growth will mostly occur in Asian megacities. In this study, a Cellular Automata based Artificial Neural Network (CA-ANN) model is used to simulate the future land use and land cover (LULC) over Delhi megacity (India). Delhi, projected to become the world's most populated city by 2030, is an example of a data poor city in Asia, having millions of climate vulnerable people. The CA-ANN model of Modules for Land Change Simulation (MOLUSCE), an open-source plugin, is first tested to simulate the LULC for 2009. Based on good validation results-structural similarity (SSIM; 0.8288), overall accuracy (79.78 %), kappa index of agreement (KIA; 77.25 %), and minimum validation overall error (0.0379), the same model set-up is used to carry out LULC simulation for 2030. This model is found to be simple, efficient, and computationally less expensive tool, and can be used to model future LULCs with a minimal set of inputs, a constraint often found in data poor cities. Results show continued increase in built-up area from 38.3 % (2014) to 53.8 % (2030), at the expense of cultivable areas, forests, and wastelands. The study incorporates past and future LULC change trajectories to highlight the changing LULC dynamics of the megacity from 1977 to 2030. Rate of urban sprawl, calculated using compound annual growth rate (CAGR) is projected to be 2.51 % for 2014-2030, substantially higher than the estimates for 2006-2014 (0.62 %). Further, the past and future urban growth patterns for Delhi are found to mimic other big Asian cities. The database generated from the present study has wide applicability for scientific research community, governmental bodies, profit and non-profit organizations for topics concerning-future urban climate research, climate risk and adaption policy frameworks, climate finance budgeting, future town planning, etc.

2.
Trials ; 25(1): 204, 2024 Mar 21.
Artigo em Inglês | MEDLINE | ID: mdl-38515103

RESUMO

BACKGROUND: Interventional clinical studies conducted in the regulated drug research environment are designed using International Council for Harmonisation (ICH) regulatory guidance documents: ICH E6 (R2) Good Clinical Practice-scientific guideline, first published in 2002 and last updated in 2016. This document provides an international ethical and scientific quality standard for designing and conducting trials that involve the participation of human subjects. Recently, there has been heightened awareness of the importance of integrated research platform trials (IRPs) designed to evaluate multiple therapies simultaneously. The use of a single master protocol as a key source document to fulfill trial conduct obligations has resulted in a re-examination of the templates used to fulfill the dynamic regulatory and modern drug development environment challenges. METHODS: Regulatory medical writing, biostatistical, and other members of EU Patient-cEntric clinicAl tRial pLatforms (EU-PEARL) developed the suite of templates for IRPs over a 3.5-year period. Stakeholders contributing expertise included academic hospitals, pharmaceutical companies, non-governmental organizations, patient representative groups, and small and medium-sized enterprises (SMEs). RESULTS: The suite of templates for IRPs based on TransCelerate's Common Protocol Template (CPT) and statistical analysis plan (SAP) should help authors navigate relevant guidelines as they create study design content relevant for today's IRP studies. It offers practical suggestions for adaptive platform designs which offer flexible features such as dropping treatments for futility or adding new treatments to be tested during a trial. The EU-PEARL suite of templates for IRPs comprises a preface, followed by the actual resource. The preface clarifies the intended use and underlying principles that inform resource utility. The preface lists references contributing to the development of the resource. The resource includes TransCelerate CPT guidance text, and EU-PEARL-derived guidance text, distinguished from one another using shading. Rationale comments are used throughout for clarification purposes. In addition, a user-friendly, functional, and informative Platform Trials Best Practices tool to support the setup, design, planning, implementation, and conduct of complex and innovative trials to support multi-sourced/multi-company platform trials is also provided. Together, the EU-PEARL suite of templates and the Platform Trials Best Practices tool constitute the reference user manual. CONCLUSIONS: This publication is intended to enhance the use, understanding, and dissemination of the EU-PEARL suite of templates for designing IRPs. The reference user manual and the associated website ( http://www.eu-pearl ) should facilitate the designing of IRP trials.


Assuntos
Ensaios Clínicos como Assunto , Projetos de Pesquisa , Ensaios Clínicos como Assunto/normas
3.
Clin Pharmacol Ther ; 116(1): 52-63, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-38529786

RESUMO

Although platform trials have many benefits, the complexity of these designs may result not only in increased methodological but also regulatory and ethical challenges. These aspects were addressed as part of the IMI project EU Patient-Centric Clinical Trial Platforms (EU-PEARL). We reviewed the available guidelines on platform trials in the European Union and the United States. This is supported and complemented by feedback received from regulatory interactions with the European Medicines Agency and the US Food and Drug Administration. Throughout the project we collected the needs of all relevant stakeholders including ethics committees, regulators, and health technology assessment bodies through active dialog and dedicated stakeholder workshops. Furthermore, we focused on methodological aspects and where applicable identified the corresponding guidance. Learnings from the guideline review, regulatory interactions, and workshops are provided. Based on these, a master protocol template was developed. Issues that still need harmonization or clarification in guidelines or where further methodological research is needed are also presented. These include questions around clinical trial submissions in Europe, the need for multiplicity control across the whole master protocol, the use of non-concurrent controls, and the impact of different randomization schemes. Master protocols are an efficient and patient-centered clinical trial design that can expedite drug development. However, they can also introduce additional operational and regulatory complexities. It is important to understand the different requirements of stakeholders upfront and address them in the trial. While relevant guidance is increasing, early dialog with relevant stakeholders can help to further support such designs.


Assuntos
Ensaios Clínicos como Assunto , Desenvolvimento de Medicamentos , União Europeia , United States Food and Drug Administration , Humanos , Ensaios Clínicos como Assunto/legislação & jurisprudência , Ensaios Clínicos como Assunto/métodos , Ensaios Clínicos como Assunto/normas , Estados Unidos , Desenvolvimento de Medicamentos/legislação & jurisprudência , Desenvolvimento de Medicamentos/métodos , Projetos de Pesquisa , Guias como Assunto , Avaliação da Tecnologia Biomédica/legislação & jurisprudência
4.
Geohealth ; 5(12): e2021GH000528, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-34988345

RESUMO

Recurrent and large forest fires negatively impact ecosystem, air quality, and human health. Moderate Resolution Imaging Spectroradiometer fire product is used to identify forest fires over central India domain, an extremely fire prone region. The study finds that from 2001 to 2020, ∼70% of yearly forest fires over the region occurred during March (1,857.5 counts/month) and April (922.8 counts/month). Some years such as 2009, 2012, and 2017 show anomalously high forest fires. The role of persistent warmer temperatures and multiple climate extremes in increasing forest fire activity over central India is comprehensively investigated. Warmer period from 2006 to 2020 showed doubling and tripling of forest fire activity during forest fire (February-June; FMAMJ) and non-fire (July-January; JASONDJ) seasons, respectively. From 2015 JASONDJ to 2018 FMAMJ, central India experienced a severe heatwave, a rare drought and an extremely strong El Niño, the combined effect of which is linked to increased forest fires. Further, the study assesses quinquennial spatiotemporal changes in forest fire characteristics such as fire count density and average fire intensity. Deciduous forests of Jagdalpur-Gadchiroli Range and Indravati National Park in Chhattisgarh state are particularly fire prone (>61 fire counts/grid) during FMAMJ and many forest fires are of high intensity (>45 MW). Statistical associations link high near surface air temperature and low precipitation during FMAMJ to significantly high soil temperature, low soil moisture content, low evapotranspiration and low normalized difference vegetation index. This creates a significantly drier environment, conducive for high forest fire activity in the region.

5.
Heliyon ; 7(5): e06973, 2021 May.
Artigo em Inglês | MEDLINE | ID: mdl-34027176

RESUMO

Crop residue burning (CRB) over northern India is a major air quality and human health issue. The present study assesses the impact of PM10, PM2.5, NO2 and SO2, emitted during CRB activities in Haryana on the air quality of Delhi. The transition from pre-burning to burning period, in both rabi and kharif seasons, shows considerable increase in pollutant concentrations. PM10 and PM2.5 concentrations exceeded NAAQS limits by 2-3 times, while NO2 and SO2 stayed within the limits. MODIS fire observations used to estimate CRB fire counts (confidence ≥80%) shows that rabi (burning period) fires in Haryana are ~3 times higher and more intense than in kharif. Furthermore, backward trajectories shows air mass movement from Haryana, Punjab and Pakistan. Thus, pollutants emitted reach Delhi via air masses, deteriorating its air quality. Meteorological conditions influence pollutant concentrations during both seasons. Frequent dust storms in rabi, and Dusshera and Diwali firework celebrations in kharif season exacerbate air pollution. In rabi, PM10 and PM2.5 have a significant negative association with (relative humidity) RH and positive association with (air temperature) AT. High AT during pre-monsoon, accompanied by low RH, loosens up soil particles and they can easily disperse. Stronger winds in rabi season promote NO2 and SO2 dispersion. In kharif, lower AT, higher RH and slower winds exist. Both PM10 and PM2.5 have a negative association with AT and (wind speed) WS. With lower temperature and slower winds during winter, pollutants are trapped within the boundary layer and are unable to disperse. As expected, NO2 has a significant negative association with AT in Haryana. However, in case of Delhi, the association is significant but positive, and could be due to the odd-even scheme imposed by the Delhi government. More research is needed to determine the health effects of Haryana's rabi CRB activities on Delhi.

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