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This document by the World Health Organization outlines innovative clinical trial designs for developing new tuberculosis (TB) treatments. It addresses the complexities and obstacles in the development of new TB drugs, emphasizing the need for shorter, safer, and more effective regimens. Key innovations include translational pharmacokinetics-pharmacodynamics modeling, novel biomarkers, adaptive trial designs, and the use of observational data. The document aims to support TB regimen development by highlighting methodologies to streamline clinical trials, accelerate drug approval, and ensure equitable access to advancements. It is intended for researchers, healthcare professionals, and policymakers involved in TB treatment development.
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This World Health Organization report focuses on enhancing and accelerating the study of new drugs for HIV and associated infections in pregnant women. It highlights the challenges faced in including pregnant women in clinical trials, due to historical exclusion policies, and the resulting delays in accessing new treatments. The report outlines a workshop co-convened by WHO and the IMPAACT Network, which brought together over 100 participants, including women living with HIV, researchers, and regulators. The workshop aimed to refine principles for studying new drugs, promote the inclusion of pregnant women in research, and develop strategic actions to improve study designs and surveillance systems. The intended audience includes healthcare professionals, researchers, and policymakers involved in HIV treatment and drug research.
HIV infections --- Clinical trials. --- Treatment.
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The revised third edition of Statistical Issues in Drug Development delivers an insightful treatment of the intersection between statistics and the life sciences. The book offers readers new discussions of crucial topics, including cluster randomization, historical controls, responder analysis, studies in children, post-hoc tests, estimands, publication bias, the replication crisis, and many more. This work presents the major statistical issues in drug development in a way that is accessible and comprehensible to life scientists working in the field, and takes pains not to gloss over significant disagreements in the field of statistics, while encouraging communication between the statistical and life sciences disciplines. In addition to new material on topics like invalid inversion, severity, random effects in network meta-analysis, and explained variation, readers will benefit from the inclusion of : A thorough introduction to basic topics in drug development and statistics, including the role played by statistics in drug development - An exploration of the four views of statistics in drug development, including the historical, methodological, technical, and professional - An examination of debatable and controversial topics in drug development, including the allocation of treatments to patients in clinical trials, baselines and covariate information, and the measurement of treatment effects. Perfect for life scientists and other professionals working in the field of drug development, Statistical Issues in Drug Development is the ideal resource for anyone seeking a one-stop reference to enhance their understanding of the use of statistics during drug development.
Clinical Trials as Topic --- Drug Design --- Statistics as Topic
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Assaigs clínics --- Assaigs terapèutics --- Estudis clínics --- Estudis terapèutics --- Experimentació humana en medicina --- Clinical trials. --- Controlled clinical trials --- Patient trials of new treatments --- Randomized clinical trials --- Trials, Clinical --- Clinical medicine --- Human experimentation in medicine --- Research
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Urologic Diseases --- Prostatic Diseases --- Evidence-Based Medicine --- Clinical Trials as Topic
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Neoplasms. --- Biomedical Research. --- Biostatistics --- Clinical Trials as Topic. --- Biométrie --- Cancérologie expérimentale --- Études cliniques --- methods.
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"This book explores the nature of the deficiencies and flaws in the evidence about the effectiveness of treatments. It is the result of a career-long interest in medical evidence. A recent career change provided an opportunity to read the extensive literature on research quality that has emerged in recent years. As befits a book on evidence, references are cited to support the statements made. Reviews and commentaries are used where available, although many landmark studies are also referenced. The approach taken is to cite sufficient papers to support a point, rather than give a comprehensive a review of it. The number of references cited reflect the wealth of evidence on the deficiencies in medical research"--
Clinical trials. --- Systematic reviews (Medical research) --- Research Design --- Randomized Controlled Trials as Topic --- Systematic Reviews as Topic --- Evidence-Based Practice --- Treatment Outcome --- standards --- standards
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"More than 50 years have passed since the use of L-dopa in the palliative treatment of Parkinson's disease, but it remains the most common treatment despite inducing severe side effects such as dyskinesia after 4-6 years of use. Numerous preclinical investigations based on endogenous neurotoxin models have promised various therapies for Parkinson's disease, but these efforts have failed when attempting to transfer these successful results to preclinical studies. Although several publications have warned of these failures, the scientific community remains mostly unaware, and there is a need to focus their efforts on potential therapeutics that can slow or halt development of the disease. Clinical Studies and Therapies in Parkinson's Disease: Translations from Preclinical Models analyzes preclinical models based on exogenous neurotoxins and why they have failed. Neuroscientists, neurologists, and neuropharmacologists will benefit greatly from the book's discussion of these newer models, their benefits, and the need for their implementation. This book also provides the basic concepts of dopamine metabolism for students taking courses in neurochemistry, neuroscience, neuropharmacology, biochemistry, and medicine"--
Parkinson's disease --- Parkinson Disease --- Treatment. --- drug therapy. --- Palsy, Shaking --- Paralysis agitans --- Parkinson disease --- Parkinsonism --- Shaking palsy --- Brain --- Extrapyramidal disorders --- Diseases --- Drugs --- Testing. --- Clinical drug trials --- Clinical trials of drugs --- Drug bioscreening --- Drug trials --- Clinical pharmacology --- Drug development --- Clinical trials --- Effectiveness --- Testing --- Evaluation
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Dermatology --- Dermatology. --- Medicine --- Skin --- Diseases --- investigative dermatology --- cutaneous biology --- cutaneous oncology --- innate and acquired immunology --- pigmentation and melanocytes --- clinical trials --- Skin Diseases --- Dermatosis --- Dermatoses --- Skin and Subcutaneous Tissue Disorders --- Skin Disease --- Peau --- Dermatologie. --- Dermatologie --- Diseases. --- Maladies. --- Cutaneous diseases
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Innovation in Clinical Trial Methodologies: Lessons Learned during the Corona Pandemic presents a selection of updated chapters from Re-Engineering Clinical Trials that feature innovative options and methods in clinical trials. The Coronavirus pandemic is an accelerator for digitalization in many industries, including clinical trials. This book considers best practices, alternative study concepts requiring fewer patients, studies with less patient interaction, the design of "virtualized" protocols, and moving from data to decisions. This book will be helpful to pharmacologists, physicians and clinical researchers involved in the process of clinical development and clinical trial design. Considers multiple digital and virtual strategies. Explores best practices, including the use of reduced patient involvement. Brings together expert, trusted information to increase the efficiency and effectiveness of clinical trials.
Drugs --- Drug development --- Clinical trials. --- Clinical Trials as Topic. --- Drug Design. --- Drug Approval. --- SARS-CoV-2. --- 2019-nCoV --- 2019 Novel Coronavirus --- COVID-19 Virus --- Coronavirus Disease 2019 Virus --- SARS Coronavirus 2 --- SARS-CoV-2 Virus --- Severe Acute Respiratory Syndrome Coronavirus 2 --- Wuhan Coronavirus --- Wuhan Seafood Market Pneumonia Virus --- 2019 Novel Coronaviruses --- COVID 19 Virus --- COVID-19 Viruses --- Coronavirus 2, SARS --- Coronavirus, 2019 Novel --- Coronavirus, Wuhan --- Novel Coronavirus, 2019 --- SARS CoV 2 Virus --- SARS-CoV-2 Viruses --- Virus, COVID-19 --- Virus, SARS-CoV-2 --- Food and Drug Administration Drug Approval --- Food and Drug Administration Drug Approval Process --- New Drug Approval Process --- Drug Approval Process --- New Drug Approval --- Approval Process, Drug --- Approval Processes, Drug --- Approval, Drug --- Approval, New Drug --- Approvals, Drug --- Approvals, New Drug --- Drug Approval Processes --- Drug Approval, New --- Drug Approvals --- Drug Approvals, New --- New Drug Approvals --- Process, Drug Approval --- Processes, Drug Approval --- Clinical Trials as Topic --- Off-Label Use --- Computer-Aided Drug Design --- Computerized Drug Design --- Drug Modeling --- Pharmaceutical Design --- Computer Aided Drug Design --- Computer-Aided Drug Designs --- Computerized Drug Designs --- Design, Computer-Aided Drug --- Design, Computerized Drug --- Design, Drug --- Design, Pharmaceutical --- Designs, Computer-Aided Drug --- Designs, Computerized Drug --- Designs, Drug --- Designs, Pharmaceutical --- Drug Design, Computer-Aided --- Drug Design, Computerized --- Drug Designs --- Drug Designs, Computer-Aided --- Drug Designs, Computerized --- Drug Modelings --- Modeling, Drug --- Modelings, Drug --- Pharmaceutical Designs --- Clinical Trial as Topic --- Clinical Protocols --- Drug Evaluation --- Drugs, Investigational --- Clinical Trials Data Monitoring Committees --- Therapies, Investigational --- Controlled clinical trials --- Patient trials of new treatments --- Randomized clinical trials --- Trials, Clinical --- Clinical medicine --- Human experimentation in medicine --- Development of drugs --- New drug development --- Pharmacology --- Pharmacy --- Clinical drug trials --- Clinical trials of drugs --- Drug bioscreening --- Drug trials --- Clinical pharmacology --- Testing. --- Safety measures. --- Research --- Development --- Clinical trials --- Effectiveness --- Testing --- Evaluation
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