2024
Adaptive multi-interventional trial platform to improve patient care for fibrotic interstitial lung diseases
Kawano-Dourado L, Kulkarni T, Ryerson C, Rivera-Ortega P, Baldi B, Chaudhuri N, Funke-Chambour M, Hoffmann-Vold A, Johannson K, Khor Y, Montesi S, Piccari L, Prosch H, Molina-Molina M, Torres J, Bauer-Ventura I, Rajan S, Jacob J, Richards D, Spencer L, Wendelberger B, Jensen T, Quintana M, Kreuter M, Gordon A, Martinez F, Kaminski N, Cornelius V, Lewis R, Adams W, Jenkins G, consortium R, Bravery A, Goodwin A, Etges A, Boshoff A, Günther A, Briggs A, Palmer A, Wilson A, Crawshaw A, Hoffmann-Vold A, Bergeron A, Holland A, Gordon A, Prasse A, Tzouvelekis A, Trachalaki A, Wells A, Nair A, Adegunsoye A, Wendelberger B, Hope-Gill B, Kaul B, Gooptu B, Baldi B, Crestani B, Polanczyk C, Vancheri C, Crobal C, Summers C, Grainge C, Ryerson C, von Garnier C, Huntley C, Ravaglia C, Valenzuela C, Hayton C, McCarthy C, Chambers D, Babalis D, Thicket D, Turner D, Talwar D, Anand D, Dhasmana D, Parek D, Griffiths D, Villegas D, Richards D, Santucci E, Bendstrup E, Balestro E, Tsitoura E, Falaschetti E, Gupta E, Farrand E, Khan F, Martinez F, Bonella F, Lombardi F, Hunninghake G, Saini G, Jenkins G, Gudmundsson G, Collard H, Parfrey H, Prosch H, Fainberg H, Adamali H, Stewart I, Forrest I, Glaspole I, Bauer-Ventura I, Noth I, Cox I, Strambu I, Sellares J, Eaden J, Johnston J, Swigris J, Blaikley J, Kim J, Chung J, Lasky J, Jacob J, Lee J, Behr J, Storrer K, Lewandowska K, Johnson K, Antoniou K, Hostettler K, Johannson K, Hurley K, Hett K, Schwarzkopf L, Fabbri L, Price L, Pearmain L, Kawano-Dourado L, Galvin L, Spencer L, Watson L, Crowley L, Richeldi L, Piccari L, Funke-Chambour M, Molina-Molina M, Jones M, Spears M, Toshner M, Wijsenbeek-Lourens M, Brutsche M, Vasakova M, Quintana M, Gibbons M, Henry M, Keane M, Kreuter M, Man M, Sadatsafavi M, Kaminski N, Chaudhuri N, Weatherley N, Hirani N, Mladinescu O, Spagnolo P, Beirne P, Bryce P, George P, Molyneaux P, Rivera-Ortega P, Crisan-Dabija R, Maida R, Borie R, Takei R, Lewis R, Rolo R, Guler S, Paganoni S, Singh S, Freitas S, Piciucchi S, Malik S, Barratt S, Hart S, Dal Corso S, Fletcher S, Stanel S, Bianchi S, Jones S, Nathan S, Rajan S, Birring S, Montesi S, Reoto T, Corte T, Zaman T, Kulkarni T, Gatheral T, Jensen T, McMillan T, Quinn V, Poletti V, Cornelius V, Cottin V, Adams W, Wuyts W, Kondoh Y, Miyazaki Y, Khor Y, Haider Y. Adaptive multi-interventional trial platform to improve patient care for fibrotic interstitial lung diseases. Thorax 2024, 79: 788-795. PMID: 38448221, PMCID: PMC11287572, DOI: 10.1136/thorax-2023-221148.Peer-Reviewed Original ResearchConceptsFibrotic interstitial lung diseaseInterstitial lung diseaseRandomised controlled trial approachTarget populationCare of peopleImprove patient careLung diseaseDisease associated with significant morbiditySafety of interventionsDissemination of resultsTrial deliveryImprove careProgression of fibrosisPatient careResponse adaptive randomisationPrimary outcomeCareSignificant morbidityAdult patientsApproaches to drug developmentClinical trialsDrug development pipelineTrial approachHeterogeneous groupPatients
2020
Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory Science
Stephenson D, Alexander R, Aggarwal V, Badawy R, Bain L, Bhatnagar R, Bloem B, Boroojerdi B, Burton J, Cedarbaum J, Cosman J, Dexter D, Dockendorf M, Dorsey E, Dowling A, Evers L, Fisher K, Frasier M, Garcia-Gancedo L, Goldsack J, Hill D, Hitchcock J, Hu M, Lawton M, Lee S, Lindemann M, Marek K, Mehrotra N, Meinders M, Minchik M, Oliva L, Romero K, Roussos G, Rubens R, Sadar S, Scheeren J, Sengoku E, Simuni T, Stebbins G, Taylor K, Yang B, Zach N. Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory Science. Digital Biomarkers 2020, 4: 28-49. PMID: 33442579, PMCID: PMC7768153, DOI: 10.1159/000512500.Peer-Reviewed Original ResearchPD clinical trialsParkinson's diseaseDigital health technologiesClinical trialsUse of DHTParkinson’s Disease Drug DevelopmentSymptoms of PDEuropean Medicines AgencyCritical Path InstituteHealth technologiesDrug development studiesClinical manifestationsPD signsRelentless progressionDisease continuumNew therapiesDrug development pipelineNovel treatmentsUS FoodDrug AdministrationMedicines AgencySubsequent approvalDrug developmentCOVID-19 pandemicTherapy
2019
OC 8721 WANECAM II – A CLINICAL TRIAL PROGRAMME TO ASSESS SAFETY, EFFICACY AND TRANSMISSION-BLOCKING PROPERTIES OF A NEW ANTIMALARIAL KAF156 (GANAPLACIDE) IN UNCOMPLICATED MALARIA IN WEST AND CENTRAL AFRICA
Djimde A, Grobusch M, Zoleko Manego R, Mombo-Ngoma G, Picot S, Sagara I, Sutherland C, Kone A, Doumbo O, Pedro Gil J, Björkman A, Borrmann S, Soulama I, Fofana B, Duparc S, Dicko A, Hughes D, Winnips C, Sirima S, Adehossi E, Ouedraogo J, Dembele L, Zongo I, Biguenet S, Ilboudo-Sanogo E, Fofana A. OC 8721 WANECAM II – A CLINICAL TRIAL PROGRAMME TO ASSESS SAFETY, EFFICACY AND TRANSMISSION-BLOCKING PROPERTIES OF A NEW ANTIMALARIAL KAF156 (GANAPLACIDE) IN UNCOMPLICATED MALARIA IN WEST AND CENTRAL AFRICA. BMJ Global Health 2019, 4: a17.3-a18. DOI: 10.1136/bmjgh-2019-edc.43.Peer-Reviewed Original ResearchTrial programNew antimalarial drug combinationMajor public health problemAntimalarial drug combinationsClinical trial programPublic health problemYears of ageNew antimalarial drugsClinical research teamRegulatory health authoritiesNew antimalarial treatmentsUncomplicated malariaFalciparum malariaAntimalarial treatmentPatient adherenceCombination therapySingle dosesClinical trialsClinical studiesKAF156Drug combinationsArtemisinin derivativesClinical developmentDrug development pipelineHealth problems
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