Works matching IS 00099236 AND DT 2022 AND VI 111 AND IP 1

Results: 38

Use of Real‐World Evidence to Drive Drug Development Strategy and Inform Clinical Trial Design.
Published in:
Clinical Pharmacology & Therapeutics, 2022, v. 111, n. 1, p. 77, doi. 10.1002/cpt.2480
By:
- Dagenais, Simon;
- Russo, Leo;
- Madsen, Ann;
- Webster, Jen;
- Becnel, Lauren
Publication type:
Article
Real‐World Evidence in EU Medicines Regulation: Enabling Use and Establishing Value.
Published in:
Clinical Pharmacology & Therapeutics, 2022, v. 111, n. 1, p. 21, doi. 10.1002/cpt.2479
By:
- Arlett, Peter;
- Kjær, Jesper;
- Broich, Karl;
- Cooke, Emer
Publication type:
Article
ASCPT News.
Published in:
Clinical Pharmacology & Therapeutics, 2022, v. 111, n. 1, p. 17, doi. 10.1002/cpt.2478
Publication type:
Article
The "Coming of Age" of Real‐World Evidence in Drug Development and Regulation.
Published in:
Clinical Pharmacology & Therapeutics, 2022, v. 111, n. 1, p. 11, doi. 10.1002/cpt.2465
Publication type:
Article
In This Issue.
Published in:
Clinical Pharmacology & Therapeutics, 2022, v. 111, n. 1, p. 9, doi. 10.1002/cpt.2484
Publication type:
Article
Integration of Real‐World Data and Genetics to Support Target Identification and Validation.
Published in:
Clinical Pharmacology & Therapeutics, 2022, v. 111, n. 1, p. 63, doi. 10.1002/cpt.2477
By:
- Davitte, Jonathan M.;
- Stott‐Miller, Marni;
- Ehm, Margaret G.;
- Cunnington, Marianne C.;
- Reynolds, Robert F.
Publication type:
Article
The Role of Real‐World Evidence in FDA‐Approved New Drug and Biologics License Applications.
Published in:
Clinical Pharmacology & Therapeutics, 2022, v. 111, n. 1, p. 135, doi. 10.1002/cpt.2474
By:
- Purpura, Christina A.;
- Garry, Elizabeth M.;
- Honig, Nicholaas;
- Case, Abigail;
- Rassen, Jeremy A.
Publication type:
Article
Highlights.
Published in:
Clinical Pharmacology & Therapeutics, 2022, v. 111, n. 1, p. 15, doi. 10.1002/cpt.2472
Publication type:
Article
Precision Reimbursement for Precision Medicine: Using Real‐World Evidence to Evolve From Trial‐and‐Project to Track‐and‐Pay to Learn‐and‐Predict.
Published in:
Clinical Pharmacology & Therapeutics, 2022, v. 111, n. 1, p. 52, doi. 10.1002/cpt.2471
By:
- Eichler, Hans‐Georg;
- Trusheim, Mark;
- Schwarzer‐Daum, Brigitte;
- Larholt, Kay;
- Zeitlinger, Markus;
- Brunninger, Martin;
- Sherman, Michael;
- Strutton, David;
- Hirsch, Gigi
Publication type:
Article
The Structured Process to Identify Fit‐For‐Purpose Data: A Data Feasibility Assessment Framework.
Published in:
Clinical Pharmacology & Therapeutics, 2022, v. 111, n. 1, p. 122, doi. 10.1002/cpt.2466
By:
- Gatto, Nicolle M.;
- Campbell, Ulka B.;
- Rubinstein, Emily;
- Jaksa, Ashley;
- Mattox, Pattra;
- Mo, Jingping;
- Reynolds, Robert F.
Publication type:
Article
From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding.
Published in:
Clinical Pharmacology & Therapeutics, 2022, v. 111, n. 1, p. 321, doi. 10.1002/cpt.2476
By:
- Thurin, Nicolas H.;
- Pajouheshnia, Romin;
- Roberto, Giuseppe;
- Dodd, Caitlin;
- Hyeraci, Giulia;
- Bartolini, Claudia;
- Paoletti, Olga;
- Nordeng, Hedvig;
- Wallach‐Kildemoes, Helle;
- Ehrenstein, Vera;
- Dudukina, Elena;
- MacDonald, Thomas;
- De Paoli, Giorgia;
- Loane, Maria;
- Damase‐Michel, Christine;
- Beau, Anna‐Belle;
- Droz‐Perroteau, Cécile;
- Lassalle, Régis;
- Bergman, Jorieke;
- Swart, Karin
Publication type:
Article
The Use of Real‐World Data to Assess the Impact of Safety‐Related Regulatory Interventions.
Published in:
Clinical Pharmacology & Therapeutics, 2022, v. 111, n. 1, p. 98, doi. 10.1002/cpt.2464
Publication type:
Article
Use of Real‐World Data and Evidence in Drug Development of Medicinal Products Centrally Authorized in Europe in 2018–2019.
Published in:
Clinical Pharmacology & Therapeutics, 2022, v. 111, n. 1, p. 310, doi. 10.1002/cpt.2462
By:
- Eskola, Sini Marika;
- Leufkens, Hubertus Gerardus Maria;
- Bate, Andrew;
- De Bruin, Marie Louise;
- Gardarsdottir, Helga
Publication type:
Article
Marketing Authorization Applications Made to the European Medicines Agency in 2018–2019: What was the Contribution of Real‐World Evidence?
Published in:
Clinical Pharmacology & Therapeutics, 2022, v. 111, n. 1, p. 90, doi. 10.1002/cpt.2461
By:
- Flynn, Robert;
- Plueschke, Kelly;
- Quinten, Chantal;
- Strassmann, Valerie;
- Duijnhoven, Ruben G.;
- Gordillo‐Marañon, Maria;
- Rueckbeil, Marcia;
- Cohet, Catherine;
- Kurz, Xavier
Publication type:
Article
Real‐World Data of Palbociclib in Combination With Endocrine Therapy for the Treatment of Metastatic Breast Cancer in Men.
Published in:
Clinical Pharmacology & Therapeutics, 2022, v. 111, n. 1, p. 302, doi. 10.1002/cpt.2454
By:
- Kraus, Albert L.;
- Yu‐Kite, Michelle;
- Mardekian, Jack;
- Cotter, Matthew J.;
- Kim, Sindy;
- Decembrino, Jaclyn;
- Snow, Tamara;
- Carson, Kenneth R.;
- Motyl Rockland, Jillian;
- Gossai, Anala;
- Wilner, Keith;
- Wang, Diane D.;
- Huang Bartlett, Cynthia;
- Oharu, Norihiko;
- Schnell, Patrick;
- VanArsdale, Todd;
- Lu, Dongrui R.;
- Tursi, Jennifer M.
Publication type:
Article
The Friends of Cancer Research Real‐World Data Collaboration Pilot 2.0: Methodological Recommendations from Oncology Case Studies.
Published in:
Clinical Pharmacology & Therapeutics, 2022, v. 111, n. 1, p. 283, doi. 10.1002/cpt.2453
By:
- Rivera, Donna R.;
- Henk, Henry J.;
- Garrett‐Mayer, Elizabeth;
- Christian, Jennifer B.;
- Belli, Andrew J.;
- Bruinooge, Suanna S.;
- Espirito, Janet L.;
- Sweetnam, Connor;
- Izano, Monika A.;
- Natanzon, Yanina;
- Robert, Nicholas J.;
- Walker, Mark S.;
- Cohen, Aaron B.;
- Boyd, Marley;
- Enewold, Lindsey;
- Hansen, Eric;
- Honnold, Rebecca;
- Kushi, Lawrence;
- Mishra Kalyani, Pallavi S.;
- Pe Benito, Ruth
Publication type:
Article
Regulator‐Requested Non‐Interventional Postauthorization Safety and Effectiveness Studies for Oncology Drugs: A Systematic Review.
Published in:
Clinical Pharmacology & Therapeutics, 2022, v. 111, n. 1, p. 155, doi. 10.1002/cpt.2450
By:
- Zhang, Xiao;
- Chen, Lei;
- Bracco, Oswaldo L.;
- Setoguchi, Soko;
- Zhou, Wei;
- Burcu, Mehmet
Publication type:
Article
Use of RWE to Inform Regulatory, Public Health Policy, and Intervention Priorities for the Developing World.
Published in:
Clinical Pharmacology & Therapeutics, 2022, v. 111, n. 1, p. 44, doi. 10.1002/cpt.2449
By:
- McNair, Douglas;
- Lumpkin, Murray;
- Kern, Steven;
- Hartman, Daniel
Publication type:
Article
Pharmacokinetic and Pharmacodynamic Characteristics of Tripegfilgrastim, a Pegylated G‐CSF, in Pediatric Patients with Solid Tumors.
Published in:
Clinical Pharmacology & Therapeutics, 2022, v. 111, n. 1, p. 293, doi. 10.1002/cpt.2433
By:
- Lee, Soyoung;
- Hong, Kyung Taek;
- Moon, Seol Ju;
- Choi, Jung Yoon;
- Hong, Che Ry;
- Shin, Hee Young;
- Cho, Joo‐Youn;
- Jang, In‐Jin;
- Yu, Kyung‐Sang;
- Oh, Jaeseong;
- Kang, Hyoung Jin
Publication type:
Article
Incretin‐Based Drugs and Risk of Intestinal Obstruction Among Patients With Type 2 Diabetes.
Published in:
Clinical Pharmacology & Therapeutics, 2022, v. 111, n. 1, p. 272, doi. 10.1002/cpt.2430
By:
- Faillie, Jean‐Luc;
- Yin, Hui;
- Yu, Oriana H. Y.;
- Herrero, Astrid;
- Altwegg, Romain;
- Renoux, Christel;
- Azoulay, Laurent
Publication type:
Article
TPMT and NUDT15 Variants Predict Discontinuation of Azathioprine for Myelotoxicity in Patients with Inflammatory Disease: Real‐World Clinical Results.
Published in:
Clinical Pharmacology & Therapeutics, 2022, v. 111, n. 1, p. 263, doi. 10.1002/cpt.2428
By:
- Dickson, Alyson L.;
- Daniel, Laura L.;
- Zanussi, Jacy;
- Dale Plummer, W.;
- Wei, Wei‐Qi;
- Liu, Ge;
- Reese, Tyler;
- Anandi, Prathima;
- Birdwell, Kelly A.;
- Kawai, Vivian;
- Cox, Nancy J.;
- Dupont, William D.;
- Hung, Adriana M.;
- Feng, QiPing;
- Stein, C. Michael;
- Chung, Cecilia P.
Publication type:
Article
Sodium Bicarbonate Prescription and Extracellular Volume Increase: Real‐world Data Results from the AlcalUN Study.
Published in:
Clinical Pharmacology & Therapeutics, 2022, v. 111, n. 1, p. 252, doi. 10.1002/cpt.2427
By:
- Beaume, Julie;
- Figueres, Lucile;
- Bobot, Mickaël;
- de Laforcade, Louis;
- Ayari, Hamza;
- Dolley‐Hitze, Thibault;
- Gueutin, Victor;
- Braconnier, Antoine;
- Golbin, Léonard;
- Citarda, Salvatore;
- Seret, Guillaume;
- Belaïd, Lisa;
- Cohen, Raphaël;
- Luque, Yosu;
- Larceneux, Fabrice;
- Seervai, Riyad N. H.;
- Overs, Camille;
- Bertocchio, Jean‐Philippe
Publication type:
Article
Evolving Acceptance and Use of RWE for Regulatory Decision Making on the Benefit/Risk Assessment of a Drug in Japan.
Published in:
Clinical Pharmacology & Therapeutics, 2022, v. 111, n. 1, p. 35, doi. 10.1002/cpt.2410
By:
- Nishioka, Kinue;
- Makimura, Tomomi;
- Ishiguro, Akihiro;
- Nonaka, Takahiro;
- Yamaguchi, Mitsune;
- Uyama, Yoshiaki
Publication type:
Article
Longitudinal Data Discontinuity in Electronic Health Records and Consequences for Medication Effectiveness Studies.
Published in:
Clinical Pharmacology & Therapeutics, 2022, v. 111, n. 1, p. 243, doi. 10.1002/cpt.2400
By:
- Joshua Lin, Kueiyu;
- Jin, Yinzhu;
- Gagne, Joshua;
- Glynn, Robert J.;
- Murphy, Shawn N.;
- Tong, Angela;
- Schneeweiss, Sebastian
Publication type:
Article
Assessing and Interpreting Real‐World Evidence Studies: Introductory Points for New Reviewers.
Published in:
Clinical Pharmacology & Therapeutics, 2022, v. 111, n. 1, p. 145, doi. 10.1002/cpt.2398
By:
- Wang, Shirley V.;
- Schneeweiss, Sebastian
Publication type:
Article
Comparative Safety of Dipeptidyl Peptidase‐4 Inhibitors and Sudden Cardiac Arrest and Ventricular Arrhythmia: Population‐Based Cohort Studies.
Published in:
Clinical Pharmacology & Therapeutics, 2022, v. 111, n. 1, p. 227, doi. 10.1002/cpt.2381
By:
- Dawwas, Ghadeer K.;
- Hennessy, Sean;
- Brensinger, Colleen M.;
- Deo, Rajat;
- Bilker, Warren B.;
- Soprano, Samantha E.;
- Dhopeshwarkar, Neil;
- Flory, James H.;
- Bloomgarden, Zachary T.;
- Aquilante, Christina L.;
- Kimmel, Stephen E.;
- Leonard, Charles E.
Publication type:
Article
Calibrating Real‐World Evidence Studies Against Randomized Trials: Treatment Effectiveness of Infliximab in Crohn's Disease.
Published in:
Clinical Pharmacology & Therapeutics, 2022, v. 111, n. 1, p. 179, doi. 10.1002/cpt.2304
By:
- Kirchgesner, Julien;
- Desai, Rishi J.;
- Beaugerie, Laurent;
- Kim, Seoyoung C.;
- Schneeweiss, Sebastian
Publication type:
Article
Issue Information.
Published in:
Clinical Pharmacology & Therapeutics, 2022, v. 111, n. 1, p. 1, doi. 10.1002/cpt.2292
Publication type:
Article
When Are Treatment Blinding and Treatment Standardization Necessary in Real‐World Clinical Trials?
Published in:
Clinical Pharmacology & Therapeutics, 2022, v. 111, n. 1, p. 116, doi. 10.1002/cpt.2256
By:
- Watanabe, Jonathan H;
- Simon, Gregory E;
- Horberg, Michael;
- Platt, Richard;
- Hernandez, Adrian;
- Califf, Robert M
Publication type:
Article
Angiotensin‐Converting Enzyme Inhibitors Used Concomitantly with Insulin Secretagogues and the Risk of Serious Hypoglycemia.
Published in:
Clinical Pharmacology & Therapeutics, 2022, v. 111, n. 1, p. 218, doi. 10.1002/cpt.2377
By:
- Hee Nam, Young;
- Brensinger, Colleen M.;
- Bilker, Warren B.;
- Flory, James H.;
- Leonard, Charles E.;
- Hennessy, Sean
Publication type:
Article
When Can Nonrandomized Studies Support Valid Inference Regarding Effectiveness or Safety of New Medical Treatments?
Published in:
Clinical Pharmacology & Therapeutics, 2022, v. 111, n. 1, p. 108, doi. 10.1002/cpt.2255
By:
- Franklin, Jessica M.;
- Platt, Richard;
- Dreyer, Nancy A.;
- London, Alex John;
- Simon, Gregory E.;
- Watanabe, Jonathan H.;
- Horberg, Michael;
- Hernandez, Adrian;
- Califf, Robert M.
Publication type:
Article
Understanding Use of Real‐World Data and Real‐World Evidence to Support Regulatory Decisions on Medical Product Effectiveness.
Published in:
Clinical Pharmacology & Therapeutics, 2022, v. 111, n. 1, p. 150, doi. 10.1002/cpt.2272
By:
- Mahendraratnam, Nirosha;
- Mercon, Kerra;
- Gill, Mira;
- Benzing, Laura;
- McClellan, Mark B.
Publication type:
Article
Prevalence of Avoidable and Bias‐Inflicting Methodological Pitfalls in Real‐World Studies of Medication Safety and Effectiveness.
Published in:
Clinical Pharmacology & Therapeutics, 2022, v. 111, n. 1, p. 209, doi. 10.1002/cpt.2364
By:
- Bykov, Katsiaryna;
- Patorno, Elisabetta;
- D'Andrea, Elvira;
- He, Mengdong;
- Lee, Hemin;
- Graff, Jennifer S.;
- Franklin, Jessica M.
Publication type:
Article
Association of Vitamin K and Non‐Vitamin K Oral Anticoagulant Use and Cancer Incidence in Atrial Fibrillation Patients.
Published in:
Clinical Pharmacology & Therapeutics, 2022, v. 111, n. 1, p. 200, doi. 10.1002/cpt.2362
By:
- Iftimi, Adina A.;
- Rodríguez‐Bernal, Clara L.;
- Peiró, Salvador;
- Bonanad, Santiago;
- Ferrero‐Gregori, Andreu;
- Hurtado, Isabel;
- García‐Sempere, Aníbal;
- Sanfélix‐Gimeno, Gabriel
Publication type:
Article
Emulating Control Arms for Cancer Clinical Trials Using External Cohorts Created From Electronic Health Record‐Derived Real‐World Data.
Published in:
Clinical Pharmacology & Therapeutics, 2022, v. 111, n. 1, p. 168, doi. 10.1002/cpt.2351
By:
- Tan, Katherine;
- Bryan, Jonathan;
- Segal, Brian;
- Bellomo, Lawrence;
- Nussbaum, Nate;
- Tucker, Melisa;
- Torres, Aracelis Z.;
- Bennette, Carrie;
- Capra, William;
- Curtis, Melissa;
- Miksad, Rebecca A.
Publication type:
Article
Uncontrolled Extensions of Clinical Trials and the Use of External Controls—Scoping Opportunities and Methods.
Published in:
Clinical Pharmacology & Therapeutics, 2022, v. 111, n. 1, p. 187, doi. 10.1002/cpt.2346
By:
- Wang, Ching‐Yu;
- Berlin, Jesse A.;
- Gertz, Barry;
- Davis, Kourtney;
- Li, Jie;
- Dreyer, Nancy A.;
- Zhou, Wei;
- Seeger, John D.;
- Santanello, Nancy;
- Winterstein, Almut G.
Publication type:
Article
When Can We Rely on Real‐World Evidence to Evaluate New Medical Treatments?
Published in:
Clinical Pharmacology & Therapeutics, 2022, v. 111, n. 1, p. 30, doi. 10.1002/cpt.2253
By:
- Simon, Gregory E.;
- Platt, Richard;
- Watanabe, Jonathan H.;
- Bindman, Andrew B.;
- John London, Alex;
- Horberg, Michael;
- Hernandez, Adrian;
- Califf, Robert M.
Publication type:
Article
When Can We Trust Real‐World Data To Evaluate New Medical Treatments?
Published in:
Clinical Pharmacology & Therapeutics, 2022, v. 111, n. 1, p. 24, doi. 10.1002/cpt.2252
By:
- Simon, Gregory E.;
- Bindman, Andrew B.;
- Dreyer, Nancy A.;
- Platt, Richard;
- Watanabe, Jonathan H.;
- Horberg, Michael;
- Hernandez, Adrian;
- Califf, Robert M.
Publication type:
Article