Practical and analytical considerations when performing interim analyses in diagnostic test accuracy studiesMethodology Published on 2024-08-202024-09-05 Journal: Diagnostic and Prognostic Research [Category] update2024, [키워드] adaptive design Diagnostic accuracy Group sequential methods interim analysis sensitivity specificity stopping rule [DOI] 10.1186/s41512-024-00174-4 PMC 바로가기 [Article Type] Methodology
The Rise of Adaptive Platform Trials in Critical CareCritical Care Perspective Published on 2024-01-252024-09-05 Journal: American Journal of Respiratory and Critical Care Medicine [Category] update2024, [키워드] adaptive design Critical care platform trials [DOI] 10.1164/rccm.202401-0101CP PMC 바로가기 [Article Type] Critical Care Perspective
Adaptive designs in critical care trials: a simulation studyarticle Published on 2023-10-182024-09-05 Journal: BMC Med Res Methodol [Category] update2024, [키워드] adaptive design Bayesian Critical care Group sequential design interim analysis Interim monitoring randomised controlled trial Statistical simulation [DOI] 10.1186/s12874-023-02049-6 PMC 바로가기 [Article Type] article
Alternative strategies in cardiac preclinical research and new clinical trial formatsReviews Published on 2022-02-082024-09-04 Journal: Cardiovascular Research [Category] 대상포진, [키워드] 3D cell culture adaptive design Alternatives to animal models clinical trials Master protocols N-of-1 trials Organ-on-a-chip Pandemic trials Preclinical research [DOI] 10.1093/cvr/cvab075 PMC 바로가기 [Article Type] Reviews
Statistical analysis plan for the OPTIMUM study: optimising immunisation using mixed schedules, an adaptive randomised controlled trial of a mixed whole-cell/acellular pertussis vaccine scheduleOPTIMUM 연구를 위한 통계 분석 계획: 혼합 일정 사용을 통한 면역 최적화, 혼합 전체 세포/세포 외 백일해 백신 일정에 대한 적응형 무작위 대조 시험Article Published on 2022-02-072024-07-28 Journal: Trials [Category] 백일해, [키워드] adaptive design food allergy pertussis vaccine randomised controlled trial Statistical analysis plan [DOI] 10.1186/s13063-021-05874-6 PMC 바로가기
Practical recommendations for implementing a Bayesian adaptive phase I design during a pandemicResearch Published on 2022-01-202022-10-28 Journal: BMC Medical Research Methodology [Category] Coronavirus, Fulltext, SARS, [키워드] adaptive adaptive design approach Bayesian COVID-19 treatments demonstrated determine dose Dose escalation Efficacy example help IMPROVE information knowledge pandemic parameter Phase I Platform trial practical delivery recommendation Result Safety Review Committee shown Statistical analysis plan supplementary material Support Treatment Trial [DOI] 10.1186/s12874-022-01512-0 PMC 바로가기 [Article Type] Research
Implementation of platform trials in the COVID-19 pandemic: A rapid reviewResearch article Published on 2022-01-012022-10-05 Journal: Contemporary clinical trials [Category] SARS, 임상, [키워드] adaptive adaptive design added Arm ARMS Bayesian methods clinical conducted COVID-19 COVID-19 pandemic defined dropped Drug development Evidence Features identify initiated IQR Master protocols median motivation pandemic platform Platform trial platform trials protocol provided Registered Regulatory Result statistical therapy treatment arm Trial trials while [DOI] 10.1016/j.cct.2021.106625 [Article Type] Research article
Exact sequential test for clinical trials and post-market drug and vaccine safety surveillance with Poisson and binary dataPoisson 및 Binary Data를 사용한 임상 시험 및 시장 후 약물 및 백신 안전 감시에 대한 정확한 순차적 테스트Article Published on 2021-09-302022-08-31 Journal: Statistics in medicine [Category] MERS, SARS, 치료제, [키워드] adaptive adaptive design addition adverse event adverse events Alpha alpha spending Analysis calculation clinical trial continuous monitoring COVID-19 pandemic decision develop effort example expected group sequential. Hypothesis Hypothesis testing Influenza influenza vaccination Osteoporosis package performed Poisson R language Sample size sample sizes sequential analysis sequential test Signaling Statistical power Surveillance threshold Treatment vaccination Vaccine [DOI] 10.1002/sim.9094 PMC 바로가기 [Article Type] Article
Chemoprophylaxis trial designs in epidemics: insights from a systematic review of COVID-19 study registrations전염병에 대한 화학 예방 실험 설계: COVID-19 연구 등록에 대한 체계적인 검토에서 얻은 통찰력Review Published on 2021-05-292022-09-10 Journal: Trials [Category] SARS, 변종, 치료기술, 치료제, [키워드] adaptive adaptive design Adaptive platform trial Adults alignment Analysis attack rate attack rates Care Chain Reaction Chemoprophylaxis Chloroquine clinically collaboration component control group coronavirus country COVID-19 COVID-19 vaccines database detect effect size effective Efficacy Efficacy and safety eligibility enrolment Epidemic Epidemics epidemiologically Evidence evidence of exit feasible feature focus followed by General population generate healthcare worker Healthcare workers Hydroxychloroquine implementation Infection Infectious disease Infectious diseases information International IQR less Long-term care Lopinavir Lopinavir/ritonavir mechanism median median size novel vaccines offer Older older adult Older adults pandemic patients polymerase chain reaction Polymerase chain reaction testing PrEP Primary outcome Prophylaxis protocol provided public health randomised Rapid recruitment Registered Repurposed drug Repurposed drugs required Result review Ritonavir robust safety analysis SARS-CoV-2 screened searched Serological testing study population supplementary material Supporting systematic review target population Trial trial infrastructure Trial registration trials utility Vaccine Vaccines virus variants was used were assessed widespread without symptom [DOI] 10.1186/s13063-021-05323-4 PMC 바로가기 [Article Type] Review
Calling for an exponential escalation scheme in vaccine development for COVID-19Point of View Published on 2020-06-162022-10-31 Journal: European Journal of Clinical Pharmacology [Category] COVID-19, MERS, SARS, [키워드] accelerated adaptive adaptive design antibody COVID-19 COVID-19 vaccine described Efficacy Escalation exponential growth feasible increased risk meet pandemic responses Result seamless Seamless trial design Side effect starting Surveillance Trial vaccination Vaccine development Vaccines Volunteer [DOI] 10.1007/s00228-020-02933-w PMC 바로가기 [Article Type] Point of View