Are novel, non‐randomised analytic methods fit for decision‐making? The need for prospective, controlled and transparent validation

  1. Eichler, Hans-Georg
  2. Koenig, Franz
  3. Arlett, Peter
  4. Enzmann, Harald
  5. Humphreys, Anthony
  6. Pétavy, Frank
  7. Schwarzer‐Daum, Brigitte
  8. Sepodes, Bruno
  9. Vamvakas, Spiros
  10. Rasi, Guido

Download
Eichler_et_al-2019-Clinical_Pharmacology_&_Therapeutics.pdf 6,63MB
WeightNameValue
1000 Titel
  • Are novel, non‐randomised analytic methods fit for decision‐making? The need for prospective, controlled and transparent validation
1000 Autor/in
  1. Eichler, Hans-Georg |
  2. Koenig, Franz |
  3. Arlett, Peter |
  4. Enzmann, Harald |
  5. Humphreys, Anthony |
  6. Pétavy, Frank |
  7. Schwarzer‐Daum, Brigitte |
  8. Sepodes, Bruno |
  9. Vamvakas, Spiros |
  10. Rasi, Guido |
1000 Erscheinungsjahr 2019
1000 Publikationstyp
  1. Artikel |
1000 Online veröffentlicht
  • 2019-10-01
1000 Erschienen in
1000 Quellenangabe
  • 106(4):681-891
1000 FRL-Sammlung
1000 Copyrightjahr
  • 2019
1000 Lizenz
1000 Verlagsversion
  • https://doi.org/10.1002/cpt.1638 |
1000 Publikationsstatus
1000 Begutachtungsstatus
1000 Sprache der Publikation
1000 Abstract/Summary
  • Real World Data (RWD) and patient‐level data from completed randomised controlled trials (RCTs) are becoming available for secondary analysis on an unprecedented scale. A range of novel methodologies and study designs have been proposed for their analysis or combination. However, to make novel analytical methods acceptable for regulators and other decision makers will require their testing and validation in broadly the same way one would evaluate a new drug: prospectively, well‐controlled and according to pre‐agreed plan. From a European regulators’ perspective, the established methods qualification advice procedure with active participation of patient groups and other decision makers is an efficient and transparent platform for the development and validation of novel study designs.
1000 Sacherschließung
lokal quantitative methods
lokal Drug development
lokal regulatory
lokal statistics
lokal epidemiology
lokal data analysi
1000 Fächerklassifikation (DDC)
1000 Liste der Beteiligten
  1. https://frl.publisso.de/adhoc/uri/RWljaGxlciwgSGFucy1HZW9yZw==|https://frl.publisso.de/adhoc/uri/S29lbmlnLCBGcmFueg==|https://frl.publisso.de/adhoc/uri/QXJsZXR0LCBQZXRlcg==|https://frl.publisso.de/adhoc/uri/RW56bWFubiwgSGFyYWxk|https://frl.publisso.de/adhoc/uri/SHVtcGhyZXlzLCBBbnRob255|https://frl.publisso.de/adhoc/uri/UMOpdGF2eSwgRnJhbmsg|https://frl.publisso.de/adhoc/uri/U2Nod2FyemVy4oCQRGF1bSwgQnJpZ2l0dGUg|https://frl.publisso.de/adhoc/uri/U2Vwb2RlcywgQnJ1bm8=|https://frl.publisso.de/adhoc/uri/VmFtdmFrYXMsIFNwaXJvcw==|https://frl.publisso.de/adhoc/uri/UmFzaSwgR3VpZG8=
1000 Label
1000 Fördernummer
  1. -
1000 Förderprogramm
  1. -
1000 Dateien
  2. CC-BY-NC 4.0
    CC-BY-NC 4.0
1000 Objektart article
1000 Beschrieben durch
1000 @id frl:6416596.rdf
1000 Erstellt am 2019-10-02T13:07:26.118+0200
1000 Erstellt von 281
1000 beschreibt frl:6416596
1000 Bearbeitet von 122
1000 Zuletzt bearbeitet Fri Jan 31 01:22:04 CET 2020
1000 Objekt bearb. Wed Oct 02 14:18:09 CEST 2019
1000 Vgl. frl:6416596
1000 Oai Id
  1. oai:frl.publisso.de:frl:6416596 |
1000 Sichtbarkeit Metadaten public
1000 Sichtbarkeit Daten public
1000 Gegenstand von

View source