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Use of Real-World Evidence to Drive Drug Development Strategy and Inform Clinical Trial Design.

Interest in real-world data (RWD) and real-world evidence (RWE) to expedite and enrich the development of new biopharmaceutical products has proliferated in recent years, spurred by the 21st Century Cures Act in the United States and similar policy efforts in other countries, willingness by regulators to consider RWE in their decisions, demands from third-party payers, and growing concerns about the limitations of traditional clinical trials. Although much of the recent literature on RWE has focused on potential regulatory uses (e.g., product approvals in oncology or rare diseases based on sin

ESMO/ASCO Recommendations for a Global Curriculum in Medical Oncology Edition 2023.

The European Society for Medical Oncology (ESMO) and ASCO are publishing a new edition of the ESMO/ASCO Global Curriculum (GC) with contributions from more than 150 authors. The purpose of the GC is to provide recommendations for the training of physicians in medical oncology and to establish a set of educational standards for trainees to qualify as medical oncologists. This edition builds on prior ones in 2004, 2010, and 2016 and incorporates scientific advances and input from an ESMO ASCO survey on GC adoption conducted in 2019, which revealed that GC has been adopted or adapted in as many a

Forecasting drug utilization and expenditure in a metropolitan health region.

BackgroundNew pharmacological therapies are challenging the healthcare systems, and there is an increasing need to assess their therapeutic value in relation to existing alternatives as well as their potential budget impact. Consequently, new models to introduce drugs in healthcare are urgently needed. In the metropolitan health region of Stockholm, Sweden, a model has been developed including early warning (horizon scanning), forecasting of drug utilization and expenditure, critical drug evaluation as well as structured programs for the introduction and follow-up of new drugs. The aim of this

Шаги в направлении внедрения нейрофильтров в множестве склерозов: характеристики пациентов, которым необходимо уделять приоритетное внимание в клинической практике.

Множественный склероз (MS) — хроническое заболевание центральной нервной системы, характеризующееся нейродегенерацией и воспалением. Нейрофильтральная световая цепочка (NfL), являющаяся белком, высвобождающимся во время аксоновых травм, получила признание в качестве потенциального биомаркера для мониторинга прогресса и реакции MS. Имеющиеся данные свидетельствуют о том, что NfL (bNfL) представляет собой минимально инвазивный, экономичный инструмент для отслеживания нейроаксональных повреждений. Регулярная оценка БНФЛ позволяет выявлять субклинические заболевания, направлять интенсификацию лече

Upfront or Deferred Autologous Stem Cell Transplantation for Newly Diagnosed Multiple Myeloma in the Era of Triplet and Quadruplet Induction and Minimal Residual Disease/Risk-Adapted Therapy.

The standards of care for the initial treatment of patients with newly diagnosed multiple myeloma (NDMM) who are eligible for high-dose melphalan and autologous stem cell transplantation (HDM-ASCT) include highly active triplet and quadruplet regimens based on proteasome inhibitors, immunomodulatory drugs, and monoclonal antibodies. These regimens are resulting in improved outcomes and increasingly high rates of minimal residual disease (MRD)-negative responses without HDM-ASCT as part of the upfront therapy. Furthermore, recent randomized studies have shown that, while transplant-based approa

Priorities in Cardio-Oncology Basic and Translational Science: GCOS 2023 Symposium Proceedings: JACC: CardioOncology State-of-the-Art Review.

Despite improvements in cancer survival, cancer therapy-related cardiovascular toxicity has risen to become a prominent clinical challenge. This has led to the growth of the burgeoning field of cardio-oncology, which aims to advance the cardiovascular health of cancer patients and survivors, through actionable and translatable science. In these Global Cardio-Oncology Symposium 2023 scientific symposium proceedings, we present a focused review on the mechanisms that contribute to common cardiovascular toxicities discussed at this meeting, the ongoing international collaborative efforts to impro

Несоответствия в рецидивной или рефрактной множественной миеломе: рекомендации межпрофессиональной консенсусной группы.

Во многих исследованиях были зафиксированы расовые, социально-экономические, географические и другие различия для пациентов из Соединенных Штатов (США) с множественной миеломой, связанные с диагностикой и управлением прифронтовыми линиями. В отличие от этого, очень мало известно о различиях в регулировании рецидивов/изъятий множественной миеломы (RRMM), несмотря на множество новых вариантов лечения. В ходе этого обзора мы обсуждаем проявления неравенства в ПРМ и стратегии по смягчению их воздействия. Лекарства от иммуномодулирующих препаратов могут создавать различия по многим осям, например н

Консолидация, систематическая оценка и сопоставление руководящих рекомендаций в отношении лечения хронической боли: Протокол для составления карты рекомендаций в отношении цифрового хронического заболевания.

ВВЕДЕНИЕ: Хроническая боль 1 В 5 :: взрослые и дети во всем мире; однако управление попрежнему носит весьма различный характер, и, как правило, обеспечивается низкий уровень медицинского обслуживания. Несогласованность рекомендаций, содержащихся в руководящих принципах клинической практики в отношении лечения хронической боли, способствует неоптимальному лечению пациентов. Мы будем разрабатывать и распространять живую цифровую карту рекомендаций в отношении хронической боли (e-Chronic Bain RecMap) для выявления заслуживающих доверия рекомендаций в three высокоприоритетные области1) опиоиды,2)

The Clinical Impact of a Multidisciplinary Strategy: Diagnostic and Therapeutic Flow-Chart for Vertebral Metastases with Spinal Cord Compression.

Introduction: Metastatic spinal cord compression (MSCC) is a life-threatening complication caused by the involvement of the spinal cord or nerve roots. It can result in severe neurological deficits, including paralysis, sensory loss, and bladder or bowel dysfunction, significantly affecting patients' quality of life. Prompt diagnosis and intervention are critical to minimizing these outcomes and improving neurological recovery. This study evaluates the efficacy of a diagnostic and therapeutic protocol introduced at our institution in 2022, designed to enhance early detection, optimize manageme

The SMARTIE Program: A Novel Initiative to Evaluate the Impact of AP Continuing Education on Clinical Practice.

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Фармакоэкономическая оценка карфилзомиба против ixazomib для лечения повторной и рефрактной множественной миеломы.

ЦЕЛЬ: В настоящем исследовании оценивается рентабельность карфилзомиба плюс линалидомида и дексаметасона (KRd) против ixazomib плюс линалидомида и дексаметазона для повторной и повторной миэломы (RRMM) в Китае. МЕТОДЫ: Модель выживания использовалась для анализа состояния здоровья и затрат на протяжении всей жизни. 4-week цикл. Воздействие обработки на выживаемость без прогрессирования (ПФС) и общее выживаемость (ОС) моделировалось с использованием коэффициентов опасности (РЧ), полученных на основе сетевого метаанализа (НМА). На основе опубликованной литературы были получены данные о стоимости

Shortage of plasma-derived medicinal products: what is next? narrative literature review on its causes and counteracting policies in Italy.

Introduction: This paper describes the peculiarities of the plasma-derived medicinal product (PDMP) market and illustrates the results of a review of the literature on policies aimed at counteracting the shortage of PDMPs. Characteristics of PDMPs: Plasma is primarily used for the industrial production of blood products (80%). The demand for PDMPs, particularly immunoglobulins (IGs), is increasing. However, the production of PDMPs is complex, long (7-12 months), and expensive, accounting, according to US estimates, for 57% of the total costs of PDMPs compared to 14% for small molecules. PDMP m

Symptom Prevalence in Spanish and Colombian Oncology Patients Measured with the MSAS.

Cancer patients experience several symptoms throughout their illness and the treatments they receive. While this pathology represents a worldwide health problem, knowing the symptom prevalence in oncology patients remains a challenge; validated tools to obtain this information are essential. Furthermore, this prevalence information would help health professionals to establish appropriate treatments. The objective of this study was to ascertain the symptom prevalence in cancer patients from Spain and Colombia to improve future approaches. The frequency, severity, and distress of 32 symptoms fro

Burden of All Cancers Along With Attributable Risk Factors in China From 1990 to 2019: Comparison With Japan, European Union, and USA.

BackgroundUnderstanding the epidemiological characteristics of various cancers can optimize the prevention and control strategies in the national cancer control plan. This study aimed to report the burden differences, pattern trend, and potential risk factors of all neoplasm types in China in recent 30 years, and further compared with top economies in the world.MethodsThe disability-adjusted life-years (DALYs) and age-standardized DALY rate (ASDR) of all neoplasms with the attributable risk factors from 1990 to 2019 in China, Japan, European Union, USA, and the world were extracted from the Gl

Development of an adult neurofibromatosis clinic in the comprehensive cancer center setting and descriptive analysis of the first 100 patients with neurofibromatosis type 1.

BACKGROUND: Neurofibromatosis type 1 is a multisystem genetic disorder that most commonly presents with dermatologic manifestations, while also involving the central and peripheral nervous systems. Additional features may include orthopedic, ophthalmologic, and cardiovascular abnormalities, and the condition is further associated with an increased risk of malignancy. Typically, patients receive multidisciplinary care in the setting of a large tertiary-care academic institution within the pediatric department. Here, we describe the development of an adult program housed within a National Cancer

New genomic and proteomic biomarker discovery in cancer: revolutionizing diagnosis and prognostication.

Cancer remains a major global health challenge, with substantial morbidity and mortality worldwide. Advances in genomic and proteomic biomarker discovery have transformed cancer diagnosis, prognosis, and treatment selection. The evolution from early serological markers such as carcinoembryonic antigen (CEA) and prostate-specific antigen (PSA) to modern multi-omics approaches enabled by next-generation sequencing (NGS), mass spectrometry (MS), and advanced bioinformatics has revolutionized personalized medicine and targeted therapy, leading to improved outcomes. This review highlights the histo

От генов к окружающей среде: жизненный подход к профилактике педиатрических аутоиммунных заболеваний.

Аутоиммунные заболевания у детей, включая тип 1 Все более серьезной проблемой для здоровья людей во всем мире являются диабет, болезни селиака и детский артрит. Этот всплеск, слишком быстрый для того, чтобы его можно было объяснить только генетическими изменениями, подчеркивает важнейшую роль экологических факторов и подчеркивает настоятельную необходимость принятия активных превентивных мер. Этот обзор представляет собой комплексную, основанную на фактических данных основу для профилактики педиатрических аутоиммунных заболеваний по всему спектру услуг, начиная с первичной и заканчивая третичн

Оказание помощи лицам, страдающим множественным склерозом, в Италии: восходящий подход проекта < < Континхом > > .

ЦЕЛЬ: В Италии, вокруг 137,000 Люди живут с множественным склерозом, сталкиваясь с организационными сложностями из-за того, что нынешняя модель уделяет ограниченное внимание уходу в непосредственной близости. Этот проект направлен на определение модели близости в соответствии с последними изменениями в итальянской системе здравоохранения, которая включает в себя: 150 Заинтересованные стороны в области здравоохранения, которые могут оказать 14,000 Пациенты. МЕТОДЫ: Был проведен анализ с целью картирования многоразового склерозового пути, после чего были проведены собеседования для выявления фак

Pyramidal Decision Support Framework Leverages Subspecialty Expertise across Enterprise to Achieve Superior Cancer Outcomes and Personalized, Precision Care Plans.

The complexity of cancer care requires integrated and continuous support to deliver appropriate care. An expert network with complementary expertise and the capability of multidisciplinary care is an integral part of contemporary oncology care. Appropriate infrastructure is necessary to empower this network to deliver personalized precision care to their patients. Providing decision support as cancer care becomes exponentially more complex with new diagnostic and therapeutic choices remains challenging. City of Hope has developed a Pyramidal Decision Support Framework to address these challeng

A mixed methods evaluation of patient perspectives on the implementation of an electronic health record-integrated patient-reported symptom and needs monitoring program in cancer care.

BACKGROUND: As cancer centers have increased focus on patient-centered, evidenced-based care, implementing efficient programs that facilitate effective patient-clinician communication remains critical. We implemented an electronic health record-integrated patient-reported symptom and needs monitoring program ('cPRO' for cancer patient-reported outcomes). To aid evaluation of cPRO implementation, we asked patients receiving care in one of three geographical regions of an academic healthcare system about their experiences. METHODS: Using a sequential mixed-methods approach, we collected feedbac

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… However, implementing an intervention as a standard of care requires strategic planning and iterative evaluation [ 15 , 16 ]. Use of implementation science (IS) methods to bridge the research-to-practice translation gap has been shown to augment success [ 17 , 18 ]. …