Single pivotal trials with few corroborating characteristics were used for FDA approval of cancer therapies
<p><strong>Background and objective </strong>Novel cancer therapies are often approved with evidence from a single pivotal trial alone. There are concerns about the credibility of this evidence. Higher validity may be indicated by five methodological and statistical characteristics...
Hlavní autoři: | Aviv, L, Speich, B, Matthias, B, Francesco, S, Heiner C, B, Arnav, A, John P.A., I, Tiago V., P, Benjamin, K, Lars G, H |
---|---|
Médium: | Journal article |
Jazyk: | English |
Vydáno: |
Elsevier
2019
|
Podobné jednotky
-
Characteristics of pivotal trials and FDA review of innovative devices.
Autor: Joshua P Rising, a další
Vydáno: (2015-01-01) -
The Comparative Effectiveness of Innovative Treatments for Cancer (CEIT-Cancer) project: Rationale and design of the database and the collection of evidence available at approval of novel drugs
Autor: Aviv Ladanie, a další
Vydáno: (2018-09-01) -
You can now search FDA approval documents easily at fda.opentrials.net
Autor: Goldacre, B, a další
Vydáno: (2017) -
Characteristics of pivotal clinical trials of FDA-approved endovascular devices between 2000 and 2018: An interrupted time series analysis
Autor: John T. Moon, a další
Vydáno: (2023-01-01) -
Overview of drugs approved by the FDA in 2022
Autor: D. V. Kurkin, a další
Vydáno: (2023-11-01)