Choose an application

• Reference Manager
• EndNote
• RefWorks (Direct export to RefWorks)

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

Choose an application

• Reference Manager
• EndNote
• RefWorks (Direct export to RefWorks)

Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines is a practical guidebook for those engaged in clinical trial design. This book details the organizations and content of clinical trials, including trial design, safety, endpoints, subgroups, HRQoL, consent forms and package inserts. It provides extensive information on both US and international regulatory guidelines and features concrete examples of study design from the medical literature. This book is intended to orient those new to clinical trial design and provide them with a better u

Clinical Trials as Topic. --- Clinical Trials Data Monitoring Committees. --- Drug Approval. --- Drug approval. --- Drug Evaluation. --- Drugs -- Testing. --- Drug approval --- Legislation, Drug --- Drug Approval --- Health Care Quality Assessment --- Health Care Quality Assurance --- Healthcare Quality Assessment --- Healthcare Quality Assurance --- Quality Assessment, Healthcare --- Quality Assurance, Healthcare --- Quality Assessment, Health Care --- Assessment, Healthcare Quality --- Assessments, Healthcare Quality --- Assurance, Healthcare Quality --- Assurances, Healthcare Quality --- Healthcare Quality Assessments --- Healthcare Quality Assurances --- Quality Assessments, Healthcare --- Quality Assurances, Healthcare --- Drug Legislation --- Drug Laws --- Food, Drug and Cosmetic Act --- Narcotic Laws --- Drug Law --- Law, Drug --- Law, Narcotic --- Laws, Drug --- Laws, Narcotic --- Narcotic Law --- Epidemiologic Method --- Epidemiological Methods --- Methods, Epidemiologic --- Epidemiological Method --- Method, Epidemiologic --- Method, Epidemiological --- Methods, Epidemiological --- Methodological Studies --- Methodological Study --- Studies, Methodological --- Study, Methodological --- Method --- Committee, Professional Staff --- Committees, Professional Staff --- Professional Staff Committee --- Staff Committee, Professional --- Staff Committees, Professional --- Drug Control --- Narcotic and Drug Control --- Pharmaceutic Policy --- Drug Regulations --- Narcotic Control --- Pharmaceutical Policy --- Control, Drug --- Control, Narcotic --- Controls, Drug --- Controls, Narcotic --- Drug Controls --- Drug Regulation --- Narcotic Controls --- Pharmaceutical Policies --- Policies, Pharmaceutical --- Policy, Pharmaceutical --- Regulation, Drug --- Regulations, Drug --- Approval of drugs --- Approval of new drugs --- Drug approval process --- New drug approval --- 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 --- Data Monitoring Committees --- Data and Safety Monitoring Boards --- Safety Monitoring Boards --- Board, Safety Monitoring --- Boards, Safety Monitoring --- Committee, Data Monitoring --- Committees, Data Monitoring --- Data Monitoring Committee --- Monitoring Board, Safety --- Monitoring Boards, Safety --- Monitoring Committee, Data --- Monitoring Committees, Data --- Safety Monitoring Board --- Clinical Trial as Topic --- Clinical trials. --- Research Design. --- Clinical trials --- Drug and Narcotic Control --- Evaluation Studies as Topic --- Professional Staff Committees --- Epidemiologic Study Characteristics as Topic --- Methods --- Research --- Epidemiologic Methods --- Investigative Techniques --- Science --- Health Care Evaluation Mechanisms --- Quality Assurance, Health Care --- Public Health --- Analytical, Diagnostic and Therapeutic Techniques and Equipment --- Social Control, Formal --- Health Care Quality, Access, and Evaluation --- Quality of Health Care --- Natural Science Disciplines --- Sociology --- Disciplines and Occupations --- Environment and Public Health --- Health Care --- Social Sciences --- Anthropology, Education, Sociology and Social Phenomena --- Clinical Trials as Topic --- Clinical Trials Data Monitoring Committees --- Research Design --- Medicine --- Health & Biological Sciences --- Medical Research --- Regulation --- Social Control --- Control, Social --- Controls, Social --- Formal Social Control --- Formal Social Controls --- Regulations --- Social Controls --- Public Policy --- Community Health --- Environment, Preventive Medicine & Public Health --- Environment, Preventive Medicine and Public Health --- Health, Community --- Health, Public --- Preventive Medicine --- Education, Public Health Professional --- Sciences --- Healthcare Evaluation Mechanisms --- Evaluation Mechanism, Healthcare --- Evaluation Mechanisms, Healthcare --- Healthcare Evaluation Mechanism --- Mechanism, Healthcare Evaluation --- Mechanisms, Healthcare Evaluation --- Pharmaceutical Preparations --- Drug Prescriptions --- Investigative Technics --- Investigative Technic --- Investigative Technique --- Technic, Investigative --- Technics, Investigative --- Technique, Investigative --- Techniques, Investigative --- Epidemiology --- Laboratory Research --- Research Activities --- Research and Development --- Research Priorities --- Activities, Research --- Activity, Research --- Development and Research --- Priorities, Research --- Priority, Research --- Research Activity --- Research Priority --- Research, Laboratory --- Ethics, Research --- Procedures --- Procedure --- Study Characteristic, Epidemiologic --- Study Characteristics, Epidemiologic --- Controlled clinical trials --- Patient trials of new treatments --- Randomized clinical trials --- Trials, Clinical --- Clinical medicine --- Human experimentation in medicine --- Hospital Administration --- Critique --- Evaluation Indexes --- Evaluation Methodology --- Evaluation Report --- Evaluation Research --- Methodology, Evaluation --- Pre-Post Tests --- Qualitative Evaluation --- Quantitative Evaluation --- Theoretical Effectiveness --- Use-Effectiveness --- Critiques --- Effectiveness, Theoretical --- Evaluation Methodologies --- Evaluation Reports --- Evaluation, Qualitative --- Evaluation, Quantitative --- Evaluations, Qualitative --- Evaluations, Quantitative --- Indexes, Evaluation --- Methodologies, Evaluation --- Pre Post Tests --- Pre-Post Test --- Qualitative Evaluations --- Quantitative Evaluations --- Report, Evaluation --- Reports, Evaluation --- Research, Evaluation --- Test, Pre-Post --- Tests, Pre-Post --- Use Effectiveness --- Substance-Related Disorders --- Pharmaceutical policy --- Data Adjustment --- Data Reporting --- Design, Experimental --- Designs, Experimental --- Error Sources --- Experimental Designs --- Matched Groups --- Methodology, Research --- Problem Formulation --- Research Methodology --- Research Proposal --- Research Strategy --- Research Technics --- Research Techniques --- Scoring Methods --- Experimental Design --- Adjustment, Data --- Adjustments, Data --- Data Adjustments --- Design, Research --- Designs, Research --- Error Source --- Formulation, Problem --- Formulations, Problem --- Group, Matched --- Groups, Matched --- Matched Group --- Method, Scoring --- Methods, Scoring --- Problem Formulations --- Proposal, Research --- Proposals, Research --- Reporting, Data --- Research Designs --- Research Proposals --- Research Strategies --- Research Technic --- Research Technique --- Scoring Method --- Source, Error --- Sources, Error --- Strategies, Research --- Strategy, Research --- Technic, Research --- Technics, Research --- Technique, Research --- Techniques, Research --- Off-Label Use --- Ethics Committees, Research --- Clinical Protocols --- Drug Evaluation --- Drugs, Investigational --- Therapies, Investigational --- Science, Social --- Sciences, Social --- Social Science --- Community-Based Distribution --- Contraceptive Distribution --- Delivery of Healthcare --- Dental Care Delivery --- Distribution, Non-Clinical --- Distribution, Nonclinical --- Distributional Activities --- Healthcare --- Healthcare Delivery --- Healthcare Systems --- Non-Clinical Distribution --- Nonclinical Distribution --- Delivery of Dental Care --- Health Care Delivery --- Health Care Systems --- Activities, Distributional --- Activity, Distributional --- Care, Health --- Community Based Distribution --- Community-Based Distributions --- Contraceptive Distributions --- Deliveries, Healthcare --- Delivery, Dental Care --- Delivery, Health Care --- Delivery, Healthcare --- Distribution, Community-Based --- Distribution, Contraceptive --- Distribution, Non Clinical --- Distributional Activity --- Distributions, Community-Based --- Distributions, Contraceptive --- Distributions, Non-Clinical --- Distributions, Nonclinical --- Health Care System --- Healthcare Deliveries --- Healthcare System --- Non Clinical Distribution --- Non-Clinical Distributions --- Nonclinical Distributions --- System, Health Care --- System, Healthcare --- Systems, Health Care --- Systems, Healthcare --- General Social Development and Population --- Natural Sciences --- Physical Sciences --- Discipline, Natural Science --- Disciplines, Natural Science --- Natural Science --- Natural Science Discipline --- Physical Science --- Science, Natural --- Science, Physical --- Sciences, Natural --- Sciences, Physical --- Pharmacy Audit --- Quality of Care --- Quality of Healthcare --- Audit, Pharmacy --- Care Qualities --- Care Quality --- Health Care Quality --- Healthcare Quality --- Pharmacy Audits --- Healthcare Quality, Access, and Evaluation --- legislation & jurisprudence --- methods --- Drugs --- Testing. --- Clinical drug trials --- Clinical trials of drugs --- Drug bioscreening --- Drug trials --- Clinical pharmacology --- Drug development --- Effectiveness --- Testing --- Evaluation