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Emphasizing Patient-Centricity Through a Tailored Training Program to Empower Patients, Advocates, and Ethics Committees in Good Clinical Practice.

ObjectivesGood Clinical Practices (GCP) are essential for patient-centric research. The standard bioethics and GCP training emphasizing a "one-size-fits-all" approach may not adequately equip ethics committee members, especially the lay and social scientist members, towards their critical role in reviewing clinical trials and related documentation. This article explores a patient-centered, patient advocates-driven training program focused on raising awareness about research ethics and GCP among patients, advocates and ethics committee members.MethodsA patient advocates-driven program called Pa

COVID-19 and haematology services in a cancer centre from a middle-income country: adapting service delivery, balancing the known and unknown during the pandemic.

The COVID-19 pandemic has caused major disruptions in multiple spheres of healthcare delivery in the world. Developing nations have had to tackle this unanticipated crisis in the midst of various other healthcare delivery issues and resource constraints. As a tertiary level cancer care provider located in an eastern Indian city, a COVID-19 hotspot, we share our experience from the perspective of haematology and haematopoietic stem cell transplantation (HSCT) services. The primary challenges related to infection control included infection screening and decreasing exposure among patients and hea

Response and Survival Estimates of Patients With Plasma Cell Myeloma in a Resource-Constrained Setting Using Protocols From High-Income Countries: A Single-Center Experience From Sri Lanka.

PURPOSE: There is a significant disparity in global cancer care and outcome between countries. Progress in the treatment of symptomatic plasma cell myeloma (PCM) in high-income countries is not seen in low- and middle-income countries. MATERIALS AND METHODS: This is was a retrospective cohort study of all patients diagnosed with PCM between May 1, 2013, and September 30, 2021, at the first hemato-oncology center in Sri Lanka. We aimed to provide data on clinicopathologic characteristics, response, and survival estimates. RESULTS: A total of 79 patients with PCM received first-line therapy du

Stakeholder perspectives and requirements to guide the development of digital technology for palliative cancer services: a multi-country, cross-sectional, qualitative study in Nigeria, Uganda and Zimbabwe.

IntroductionCoverage of palliative care in low and middle-income countries is very limited, and global projections suggest large increases in need. Novel approaches are needed to achieve the palliative care goals of Universal Health Coverage. This study aimed to identify stakeholders' data and information needs and the role of digital technologies to improve access to and delivery of palliative care for people with advanced cancer in Nigeria, Uganda and Zimbabwe.MethodsWe conducted a multi-country cross-sectional qualitative study in sub-Saharan Africa. In-depth qualitative stakeholder intervi

Создание в Азиатско-Тихоокеанском регионе реестра многочисленных клинических заболеваний миеломы: Азиатско-тихоокеанский регистр миеломы и связанных с ней заболеваний (АТАК МДРБ).

Множественная миелома (ММ) является вторым по распространенности гематологическим раком во всем мире. Наряду с связанными с этим заболеваниями, включая моноклональную гаммопатию неопределенного значения (MMUS), лейкемию плазменных клеток (PCL) и плазмоцитому, заболеваемость MM возрастает, однако она остается неизлечимой и представляет собой значительное бремя болезней. Клинические реестры могут обеспечивать важную информацию об управлении и результатах и служить жизненно важной платформой для клинических испытаний и других исследований. Для мониторинга и изучения вариаций в эпидемиологии, режи

Insights into the Impact of Hesitancy on Cancer Care and COVID-19.

World Health Organization findings indicate that the COVID-19 pandemic adversely affected cancer diagnosis and management. The COVID-19 pandemic disrupted the optimal management of outpatient appointments, scheduled treatments, and hospitalizations for cancer patients because of hesitancy among patients and health-care providers. Travel restrictions and other factors likely affected medical, surgical, and radiation treatments during the COVID-19 pandemic. Cancer patients were more likely to be affected by severe illness and complications if they contracted COVID-19. A compromised immune system

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… Health-care organizations have a crucial role to play in eliminating vaccine hesitancy by dispelling disinformation, engaging the public with vaccine education and finding common ground to accept vaccines, while also partnering with state and local governments to boost vaccination rates. …

Building a Sustainable Comprehensive Multiple Myeloma Program in Western Kenya.

Despite improved treatment strategies for multiple myeloma (MM), patient outcomes in low- and middle-income countries remain poor, unlike high-income countries. Scarcity of specialized human resources and diagnostic, treatment, and survivorship infrastructure are some of the barriers that patients with MM, clinicians, and policymakers have to overcome in the former setting. To improve outcomes of patients with MM in Western Kenya, the Academic Model Providing Access to Healthcare (AMPATH) MM Program was set up in 2012. In this article, the program's activities, challenges, and future plans are

The first hematopoietic stem cell transplantation centre in Iraqi Kurdistan: nursing perspectives and education.

AimTo describe the nursing capacity-building process within the foundation of a hematopoietic stem cell transplantation (HSCT) centre at the Hiwa Cancer Hospital (HCH), Sulaymaniyah, Iraqi Kurdistan, referring to nursing education, empowerment and leadership.Methods1) Capacity building, the process by which individuals, organisations, institutions and societies develop abilities to perform functions, solve problems and set and achieve objectives, was implemented; 2) Nurse intervention was based exclusively on training and coaching on site, which is an innovative approach, since more often expe

The Minderoo-Monaco Commission on Plastics and Human Health.

BACKGROUND: Plastics have conveyed great benefits to humanity and made possible some of the most significant advances of modern civilization in fields as diverse as medicine, electronics, aerospace, construction, food packaging, and sports. It is now clear, however, that plastics are also responsible for significant harms to human health, the economy, and the earth's environment. These harms occur at every stage of the plastic life cycle, from extraction of the coal, oil, and gas that are its main feedstocks through to ultimate disposal into the environment. The extent of these harms not been

Why and How Should Ethiopia Establish a Stem Cell Transplant Service? A Review Article.

Ethiopia is attempting to reduce cancer-related morbidity and mortality through a strategic national cancer control plan but according to Globocan 2020, hematologic malignancies particularly leukemia and non-Hodgkin's lymphoma rank among the top five leading causes of new cancer incidence and cause of death among all age groups in both sexes. Hematopoietic stem-cell transplantation (HSCT) is an advanced treatment modality that makes the only effective treatment for cancer and non-cancer-related hematologic diseases unresponsive to conventional therapy. Patients who need stem cell transplants m

Enhancing the Safety of Nanoparticles in Medicine: Highlights of Progress and Critical Objectives.

Nanoparticles have transformed drug delivery, imaging, vaccination, and precision therapeutics, but their clinical translation remains constrained by safety profiles that are inseparable from material design, biological identity, host factors, and manufacturing. This review critically evaluates recent progress, persistent limitations, and priority objectives for safer nanomedicine. Unlike reviews organized primarily by material class or isolated toxicology endpoints, we integrate physicochemical determinants, protein corona formation, immune recognition, organ disposition, preclinical models,

A roadmap for establishing institutional readiness for cellular therapies targeting solid tumours and autoimmune diseases.

Adoptive cellular therapies have revolutionised treatment of haematological malignancies and demonstrate potential in solid tumours and autoimmune disease. Real-world implementation remains limited by biological, logistical, and manufacturing barriers, restricting global uptake despite a rapidly expanding clinical trial portfolio. Effective implementation requires national and institutional readiness, multidisciplinary collaboration, scalable manufacturing, and robust infrastructure. Efforts should prioritise decentralised and "off the shelf" platforms, integrated referral networks, and AI-ass

The UK's Early Access to Medicines Scheme 10 years on: an evaluation using publicly available data.

ObjectivesTo investigate the drugs and indications that have passed through the UK's Early Access to Medicines Scheme (EAMS) to date, the type of evidence the regulator considers when accepting a drug into the EAMS, and potential risks to patients.DesignAnalysis of publicly available data: MHRA Public Assessment Reports; Electronic Medicines Compendium database; interactive Drug Analysis Profiles database; Eudravigilance database.SettingUnited Kingdom.ParticipantsThe 51 'scientific opinions' available on the MHRA website in June 2024.Main outcome measuresPublic Assessment Reports, pharmacovigi

Patent pooling to increase access to essential medicines.

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Regulatory insights on gene therapies, adeno-associated virus-based gene therapies, cell/tissue-based products, and medical care/practice in cell and gene therapies: Report from the 7th Asia partnership conference - April 25, 2024.

The 7th Asia Partnership Conference of Regenerative Medicine (APACRM) was held both in person and online on April 25, 2024, to promote the regulatory harmonization of regenerative medicine products across Asia. Recognizing domestic regulatory guidelines and their underlying rationales within each country and region is an important initial step toward achieving harmonious regulation. The 7th APACRM featured open dialogues on the non-clinical evaluations of adeno-associated virus gene therapy products, regulation of gene therapies, considerations for conducting clinical trials, and provision of

Barriers to the Provision and Utilization of Palliative Care in Africa: A Rapid Scoping Review.

Palliative care (PC) has continued to be less available, underutilized, and unintegrated in many of the healthcare systems, especially in Africa. This scoping review synthesized existing published papers on adult PC in Africa, to report the barriers to PC and to assess the methodologies used in these studies. Eight electronic databases and Google Scholar were searched to identify relevant studies published between 2005 and 2018. Overall, 42 publications (34 empirical studies and 9 reviews) that reported issues related to barriers to adult PC were selected. Three themes identified were individu

The PRO-CAR-T™ study: achieving excellence in patient and public involvement and engagement.

BackgroundPatient and Public Involvement and Engagement (PPIE) is advocated in Patient Reported Outcome (PRO) research, but implementation remains inconsistent and often suboptimal. Many barriers exist, including a lack of understanding about how to apply the principles of PPIE in practice. This paper offers an example of how PPIE can be meaningfully integrated into the development of a digital PRO system within the complex and rapidly evolving field of advanced therapies. The aims are to offer practical insights about how PPIE was conceptualised and operationalised in the context of this stud

Cost-effectiveness of cancer interventions in Rwanda: literature review and expert elicitation for health benefits package design.

IntroductionPrioritising health benefits packages (HBPs) that specify which health services are covered under insurance is sometimes done in disease-specific clusters. Cancer is a good candidate for this, given its high cost and rising disease burden, particularly in low- and middle-income countries.The Government of Rwanda assessed 49 cancers against nine criteria to inform the design of its HBP. Each cancer had a basic, core and enhanced package of services, and one preventive intervention was assessed, totalling 148 interventions. This paper focuses on the results of one criterion: cost-eff

Измерение " углеродного следа " клинических исследований: аналитический обзор инструментов и методов измерения.

Медицинское обслуживание вносит существенный вклад в глобальные выбросы парниковых газов; однако воздействие клинических исследований на окружающую среду по-прежнему недостаточно изучено. Количественная оценка выбросов является необходимым первым шагом на пути к сокращению углеродного следа исследований. С момента создания базы данных до июня 2026 года были проведены обыски PubMed, Web of Science, CINAHL, Scopus, EconBiz, GreenFile и ProQuest. В соответствующих исследованиях сообщается об измерении выбросов углерода, связанных с клиническими исследованиями. Данные были составлены и обобщены в

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… For researchers that require regional accuracy, combining international databases with local government resources (DEFRA for the UK, 21 28 32 Australian statistics, 22 Singapore data, 23 South Africa data 35 ) balances using a recognised global methodology with geographic precision. …

Cancer burden across the South Asian Association for Regional Cooperation in 2022.

ObjectiveThe objective of this study is to present a cross-sectional analysis of cancer burden in the South Asian Association for Regional Cooperation (SAARC) region and explain unique characteristics of its cancer burden as compared with the rest of the world.Methods and analysisUsing publicly available data from the Global Cancer Observatory (GCO) and the World Bank, we collected cancer statistics and population statistics for Afghanistan, Bangladesh, Bhutan, India, the Maldives, Nepal, Pakistan, and Sri Lanka from 2017 to 2022.ResultsThe number of newly diagnosed cases in the region was 1 8