Results 11 to 20 of about 5,351,550 (365)

FDA Acceptance of Surrogate End Points for Cancer Drug Approval: 1992-2019.

JAMA Intern Med, 2020
This retrospective review assesses the frequency of surrogate measures used for the first time vs subsequent times in a cancer setting and the surrogate’s strength of correlation with patient-centered outcomes.
Chen EY, Haslam A, Prasad V.
europepmc   +2 more sources

Approval success rates of drug candidates based on target, action, modality, application, and their combinations

Clinical and Translational Science, 2021
The current success rate of a drug candidate, from the beginning of the clinical trial to receiving marketing approval, is about 10%–20%, and it has not changed during the past few decades. Therefore, pharmaceutical companies are under pressure to select
Shingo Yamaguchi, Masayuki Kaneko, Mamoru Narukawa   +2 more
doaj   +2 more sources

The use of mechanistic evidence in drug approval. [PDF]

J Eval Clin Pract, 2018
The role of mechanistic evidence tends to be under‐appreciated in current evidence‐based medicine (EBM), which focusses on clinical studies, tending to restrict attention to randomized controlled studies (RCTs) when they are available. The EBM+ programme
Aronson JK, La Caze A, Kelly MP, Parkkinen VP, Williamson J.   +4 more
europepmc   +2 more sources

Patient-Centered Drug Approval: The Role of Patient Advocacy in the Drug Approval Process. [PDF]

J Manag Care Spec Pharm, 2017
Recent approval of eteplirsen for Duchenne muscular dystrophy (DMD), a rare disease with few treatment alternatives, has reignited the debate over the U.S. drug approval process.
Mattingly TJ, Simoni-Wastila L.
europepmc   +2 more sources

Disease modification in osteoarthritis; pathways to drug approval [PDF]

Osteoarthritis and Cartilage Open, 2020
Summary: Objective: To summarize proceedings of a workshop convened to discuss advances in disease modifying osteoarthritis (OA) drugs and regulatory challenges in bringing these drugs to market. Design: Summary of a one day workshop held in Washington,
Jeffrey N. Katz, Tuhina Neogi, Leigh F. Callahan, Joel A. Block, Philip G. Conaghan, Lee S. Simon, Virginia Byers Kraus, Marc C. Hochberg   +7 more
doaj   +2 more sources

Analysis of Control Arm Quality in Randomized Clinical Trials Leading to Anticancer Drug Approval by the US Food and Drug Administration.

JAMA Oncol, 2019
Importance To date, an empirical evaluation of the quality of control arms in randomized clinical trials (RCTs) leading to anticancer drug approvals by the US Food and Drug Administration (FDA) has not been undertaken.
Hilal T, Sonbol MB, Prasad V.
europepmc   +2 more sources

Factors Affecting Drug-Development Strategies in Asian Global Clinical Trials for Drug Approval in Japan. [PDF]

Clin Transl Sci, 2018
We assessed the current status of Asian global clinical trials (GCTs) and factors, such as therapeutic areas, main metabolic enzymes targeted, approval status in the United States or the European Union, development strategies, influencing drug ...
Asano K, Uyama Y, Tohkin M.
europepmc   +2 more sources

Physicians' Trust in the FDA's Use of Product-Specific Pathways for Generic Drug Approval. [PDF]

PLoS One, 2016
Background Generic drugs are cost-effective versions of brand-name drugs approved by the Food and Drug Administration (FDA) following proof of pharmaceutical equivalence and bioequivalence.
Kesselheim AS, Eddings W, Raj T, Campbell EG, Franklin JM, Ross KM, Fulchino LA, Avorn J, Gagne JJ.   +8 more
europepmc   +2 more sources

ChemAP: predicting drug approval with chemical structures before clinical trial phase by leveraging multi-modal embedding space and knowledge distillation [PDF]

Scientific Reports
Recent studies showed that the likelihood of drug approval can be predicted with clinical data and structure information of drug using computational approaches. Predicting the likelihood of drug approval can be innovative and of high impact.
Changyun Cho, Sangseon Lee, Dongmin Bang, Yinhua Piao, Sun Kim   +4 more
doaj   +2 more sources

Special FDA designations for drug development: orphan, fast track, accelerated approval, priority review, and breakthrough therapy

The European journal of health economics : HEPAC : health economics in prevention and care, 2023
Background Over the past decades, US Congress enabled the US Food and Drug Administration (FDA) to facilitate and expedite drug development for serious conditions filling unmet medical needs with five special designations and review pathways: orphan ...
D. Michaeli, T. Michaeli, S. Albers, Tobias Boch, J. Michaeli   +4 more
semanticscholar   +1 more source