Establishing a Public Resource for Acceptable Surrogate Endpoints to Support FDA Marketing Applications
Copyright © 2022 Agyeman, Siegel and Leptak..
Following a comprehensive and coordinated effort between CBER and CDER, FDA established a table of acceptable surrogate endpoints (SEs) to support drug marketing applications. The publicly accessible SE Table was first published in 2018 as a response to the 21st Century Cures Act legislation and is updated every 6 months to reflect current FDA thinking. The criteria for the table headings and content were chosen to foster succinctness and consistency, while reflecting the degree of scientific understanding for each listed SE. Prior to the publication of the SE table there was the misconception that FDA only approved drugs based on a limited number of SEs. Contrary to this viewpoint, the SE table demonstrates that FDA frequently uses SEs as they are used in over 100 disease/use and patient population combinations. This article describes the considerations and approach taken when establishing the SE table as well as a discussion of the benefits and limitations of the SE table when used by various stakeholders.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2022 |
|---|---|
| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:9 |
|---|---|
| Enthalten in: |
Frontiers in medicine - 9(2022) vom: 26., Seite 820990 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Agyeman, Abena S [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
21st Century Cures Act |
|---|
| Anmerkungen: |
Date Revised 08.03.2022 published: Electronic-eCollection Citation Status PubMed-not-MEDLINE |
|---|
| doi: |
10.3389/fmed.2022.820990 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM337833214 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM337833214 | ||
| 003 | DE-627 | ||
| 005 | 20231225235321.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231225s2022 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.3389/fmed.2022.820990 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1126.xml |
| 035 | |a (DE-627)NLM337833214 | ||
| 035 | |a (NLM)35252258 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Agyeman, Abena S |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Establishing a Public Resource for Acceptable Surrogate Endpoints to Support FDA Marketing Applications |
| 264 | 1 | |c 2022 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Revised 08.03.2022 | ||
| 500 | |a published: Electronic-eCollection | ||
| 500 | |a Citation Status PubMed-not-MEDLINE | ||
| 520 | |a Copyright © 2022 Agyeman, Siegel and Leptak. | ||
| 520 | |a Following a comprehensive and coordinated effort between CBER and CDER, FDA established a table of acceptable surrogate endpoints (SEs) to support drug marketing applications. The publicly accessible SE Table was first published in 2018 as a response to the 21st Century Cures Act legislation and is updated every 6 months to reflect current FDA thinking. The criteria for the table headings and content were chosen to foster succinctness and consistency, while reflecting the degree of scientific understanding for each listed SE. Prior to the publication of the SE table there was the misconception that FDA only approved drugs based on a limited number of SEs. Contrary to this viewpoint, the SE table demonstrates that FDA frequently uses SEs as they are used in over 100 disease/use and patient population combinations. This article describes the considerations and approach taken when establishing the SE table as well as a discussion of the benefits and limitations of the SE table when used by various stakeholders | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a 21st Century Cures Act | |
| 650 | 4 | |a accelerated approval | |
| 650 | 4 | |a biomarker | |
| 650 | 4 | |a reasonably likely surrogated endpoint | |
| 650 | 4 | |a surrogate endpoint | |
| 650 | 4 | |a traditional approval | |
| 650 | 4 | |a validated surrogate endpoint | |
| 700 | 1 | |a Siegel, Jeffrey N |e verfasserin |4 aut | |
| 700 | 1 | |a Leptak, Christopher |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Frontiers in medicine |d 2014 |g 9(2022) vom: 26., Seite 820990 |w (DE-627)NLM245390847 |x 2296-858X |7 nnns |
| 773 | 1 | 8 | |g volume:9 |g year:2022 |g day:26 |g pages:820990 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.3389/fmed.2022.820990 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 9 |j 2022 |b 26 |h 820990 | ||