Results 41 to 50 of about 2,242,374 (316)

Real‐world evidence on the utilization, clinical and comparative effectiveness, and adverse effects of newer GLP‐1RA‐based weight‐loss therapies

Diabetes, obesity and metabolism
Glucagon‐like peptide‐1 receptor agonists (GLP‐1RAs) have emerged as key agents for weight management, based on their marked efficacy as observed in randomized controlled trials.
R. Thomsen, Aurélie Mailhac, J. B. Løhde, A. Pottegård   +3 more
semanticscholar   +1 more source

A Structured Process to Identify Fit‐for‐Purpose Study Design and Data to Generate Valid and Transparent Real‐World Evidence for Regulatory Uses

Clinical pharmacology and therapy, 2023
Generating evidence from real‐world data requires fit‐for‐purpose study design and data. In addition to validity, decision makers require transparency in the reasoning that underlies study design and data source decisions. The 2019 Structured Preapproval
N. Gatto, S. Vititoe, E. Rubinstein, R. Reynolds, U. Campbell   +4 more
semanticscholar   +1 more source

The relevance of the real-world evidence in research, clinical, and regulatory decision making

Frontiers in Public Health
The scientific method has been established as the optimal approach for systematically gathering and interpreting data on various human phenomena, mainly through the adoption of strict experimental methods, such as controlled randomized trials, which is ...
Valton Costa, Marcelo Graziano Custodio, E. Gefen, F. Fregni   +3 more
semanticscholar   +1 more source

Real-world evidence for the effectiveness and safety of dupilumab in patients with CRSwNP after 1 year of therapy

The World Allergy Organization Journal, 2023
Objectives For nearly 3 years, the monoclonal antibody dupilumab has been approved in Germany for the treatment of patients with chronic rhinosinusitis with nasal polyps (CRSwNP).
T. Albrecht, Martin M. Sailer, Flavia Capitani, C. van Schaik, H. Löwenheim, S. Becker   +5 more
semanticscholar   +1 more source

Impact of "time zero" of Follow-Up Settings in a Comparative Effectiveness Study Using Real-World Data with a Non-user Comparator: Comparison of Six Different Settings

Drugs - Real World Outcomes, 2022
Background Time-related bias can lead to misleading conclusions. Properly setting the "time zero" of follow-up is crucial for avoiding these biases. However, the time-zero setting is challenging when comparing users and non-users of a study drug because ...
Ryozo Wakabayashi, Takahiro Hirano, Thomas Laurent, Yoshiki Kuwatsuru, Ryohei Kuwatsuru   +4 more
doaj   +1 more source

Real-world treatment patterns and outcomes among individuals receiving first-line pembrolizumab therapy for recurrent/metastatic head and neck squamous cell carcinoma

Frontiers in Oncology, 2023
BackgroundPembrolizumab, a PD-1 immune checkpoint inhibitor, is approved as first-line (1L) treatment for recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) as monotherapy or in combination with platinum and 5-fluorouracil ...
Christopher M. Black, Glenn J. Hanna, Liya Wang, Karthik Ramakrishnan, Daisuke Goto, Vladimir Turzhitsky, Gleicy M. Hair   +6 more
doaj   +1 more source

Emulating Randomized Clinical Trials with Nonrandomized Real-World Evidence Studies: First Results from the RCT DUPLICATE Initiative.

Circulation, 2020
Background: Regulators are evaluating the use of non-interventional real-world evidence (RWE) studies to assess the effectiveness of medical products.
J. Franklin, Elisabetta Patorno, R. Desai, R. Glynn, David Martin, K. Quinto, Ajinkya M Pawar, Lily G. Bessette, Hemin Lee, E. Garry, N. Gautam, S. Schneeweiss   +11 more
semanticscholar   +1 more source

Rationale, Strengths, and Limitations of Real-World Evidence in Oncology: A Canadian Review and Perspective

The Oncologist, 2022
Randomized controlled trials (RCTs) continue to be the basis for essential evidence regarding the efficacy of interventions such as cancer therapies.
L. Azoulay
semanticscholar   +1 more source

Health-related quality of life burden of nonalcoholic steatohepatitis: a robust pragmatic literature review

Journal of Patient-Reported Outcomes, 2018
Objective Nonalcoholic steatohepatitis (NASH) is a form of chronic liver disease (CLD): patients have an increased risk of developing cirrhosis, liver failure, and complications (e.g. hepatocellular carcinoma). NASH has a high clinical burden, and likely
Tessa Kennedy-Martin, Jay P. Bae, Rosirene Paczkowski, Emily Freeman   +3 more
doaj   +1 more source

Evaluating the Performance of High-Dimensional Propensity Scores Compared with Standard Propensity Scores for Comparing Antihypertensive Therapies in the CPRD GOLD Database

Cardiology and Therapy, 2023
Introduction Propensity score (PS) matching is widely used in medical record studies to create balanced treatment groups, but relies on prior knowledge of confounding factors.
Virginie Simon, Jade Vadel
doaj   +1 more source