Sökning: onr:"swepub:oai:DiVA.org:uu-239848" > Clinical end points...
Fältnamn | Indikatorer | Metadata |
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000 | 03986naa a2200613 4500 | |
001 | oai:DiVA.org:uu-239848 | |
003 | SwePub | |
008 | 150102s2015 | |||||||||||000 ||eng| | |
009 | oai:prod.swepub.kib.ki.se:130480588 | |
024 | 7 | a https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-2398482 URI |
024 | 7 | a https://doi.org/10.1038/leu.2014.2502 DOI |
024 | 7 | a http://kipublications.ki.se/Default.aspx?queryparsed=id:1304805882 URI |
040 | a (SwePub)uud (SwePub)ki | |
041 | a engb eng | |
042 | 9 SwePub | |
072 | 7 | a ref2 swepub-contenttype |
072 | 7 | a art2 swepub-publicationtype |
100 | 1 | a Barosi, G4 aut |
245 | 1 0 | a Clinical end points for drug treatment trials in BCR-ABL1-negative classic myeloproliferative neoplasms :b consensus statements from European LeukemiaNET (ELN) and Internation Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) |
264 | c 2014-08-25 | |
264 | 1 | b Springer Science and Business Media LLC,c 2015 |
338 | a print2 rdacarrier | |
520 | a The discovery of somatic mutations, primarily JAK2V617F and CALR, in classic BCR-ABL1-negative myeloproliferative neoplasms (MPNs) has generated interest in the development of molecularly targeted therapies, whose accurate assessment requires a standardized framework. A working group, comprised of members from European LeukemiaNet (ELN) and International Working Group for MPN Research and Treatment (IWG-MRT), prepared consensus-based recommendations regarding trial design, patient selection and definition of relevant end points. Accordingly, a response able to capture the long-term effect of the drug should be selected as the end point of phase II trials aimed at developing new drugs for MPNs. A time-to-event, such as overall survival, or progression-free survival or both, as co-primary end points, should measure efficacy in phase III studies. New drugs should be tested for preventing disease progression in myelofibrosis patients with early disease in randomized studies, and a time to event, such as progression-free or event-free survival should be the primary end point. Phase III trials aimed at preventing vascular events in polycythemia vera and essential thrombocythemia should be based on a selection of the target population based on new prognostic factors, including JAK2 mutation. In conclusion, we recommended a format for clinical trials in MPNs that facilitates communication between academic investigators, regulatory agencies and drug companies. | |
650 | 7 | a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Hematologi0 (SwePub)302022 hsv//swe |
650 | 7 | a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Hematology0 (SwePub)302022 hsv//eng |
700 | 1 | a Tefferi, A4 aut |
700 | 1 | a Besses, C4 aut |
700 | 1 | a Birgegård, Gunnaru Uppsala universitet,Hematologi4 aut0 (Swepub:uu)gunnarbg |
700 | 1 | a Cervantes, F4 aut |
700 | 1 | a Finazzi, G4 aut |
700 | 1 | a Gisslinger, H4 aut |
700 | 1 | a Griesshammer, M4 aut |
700 | 1 | a Harrison, C4 aut |
700 | 1 | a Hehlmann, R4 aut |
700 | 1 | a Hermouet, S4 aut |
700 | 1 | a Kiladjian, J-J4 aut |
700 | 1 | a Kröger, N4 aut |
700 | 1 | a Mesa, R4 aut |
700 | 1 | a Mc Mullin, M F4 aut |
700 | 1 | a Pardanani, A4 aut |
700 | 1 | a Passamonti, F4 aut |
700 | 1 | a Samuelsson, Ju Karolinska Institutet4 aut |
700 | 1 | a Vannucchi, A M4 aut |
700 | 1 | a Reiter, A4 aut |
700 | 1 | a Silver, R T4 aut |
700 | 1 | a Verstovsek, S4 aut |
700 | 1 | a Tognoni, G4 aut |
700 | 1 | a Barbui, T4 aut |
710 | 2 | a Uppsala universitetb Hematologi4 org |
773 | 0 | t Leukemiad : Springer Science and Business Media LLCg 29:1, s. 20-26q 29:1<20-26x 0887-6924x 1476-5551 |
856 | 4 | u https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8764620 |
856 | 4 8 | u https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-239848 |
856 | 4 8 | u https://doi.org/10.1038/leu.2014.250 |
856 | 4 8 | u http://kipublications.ki.se/Default.aspx?queryparsed=id:130480588 |
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