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Early market access of cancer drugs in the EU.
Martinalbo J, Bowen D, Camarero J, Chapelin M, Démolis P, Foggi P, Jonsson B, Llinares J, Moreau A, O'Connor D, Oliveira J, Vamvakas S, Pignatti F. Martinalbo J, et al. Ann Oncol. 2016 Jan;27(1):96-105. doi: 10.1093/annonc/mdv506. Epub 2015 Oct 20. Ann Oncol. 2016. PMID: 26487583 Free article. Review.
Recommendations on the use of item libraries for patient-reported outcome measurement in oncology trials: findings from an international, multidisciplinary working group.
Piccinin C, Basch E, Bhatnagar V, Calvert M, Campbell A, Cella D, Cleeland CS, Coens C, Darlington AS, Dueck AC, Groenvold M, Herold R, King-Kallimanis BL, Kluetz PG, Kuliś D, O'Connor D, Oliver K, Pe M, Reeve BB, Reijneveld JC, Wang XS, Bottomley A. Piccinin C, et al. Lancet Oncol. 2023 Feb;24(2):e86-e95. doi: 10.1016/S1470-2045(22)00654-4. Lancet Oncol. 2023. PMID: 36725153 Review.
Changing views on adverse event reporting.
Flores B, Klaar S, O'Connor DJ. Flores B, et al. Lancet Haematol. 2018 Nov;5(11):e506-e507. doi: 10.1016/S2352-3026(18)30074-7. Epub 2018 Jun 12. Lancet Haematol. 2018. PMID: 29907550 No abstract available.
The European medicines agency review of abiraterone for the treatment of metastatic castration-resistant prostate cancer in adult men after docetaxel chemotherapy and in chemotherapy-naive disease: summary of the scientific assessment of the committee for medicinal products for human use.
Gravanis I, Lopez AS, Hemmings RJ, Jiménez JC, Garcia-Carbonero R, Gallego IG, Giménez EV, O'Connor D, Giuliani R, Salmonson T, Pignatti F. Gravanis I, et al. Oncologist. 2013;18(9):1032-42. doi: 10.1634/theoncologist.2013-0092. Epub 2013 Aug 21. Oncologist. 2013. PMID: 23966222 Free PMC article.
Informing the Tolerability of Cancer Treatments Using Patient-Reported Outcome Measures: Summary of an FDA and Critical Path Institute Workshop.
Kluetz PG, Kanapuru B, Lemery S, Johnson LL, Fiero MH, Arscott K, Barbachano Y, Basch E, Campbell M, Cappelleri JC, Cella D, Cleeland C, Coens C, Daniels S, Denlinger CS, Fairclough DL, Hillard JR, Minasian L, Mitchell SA, O'Connor D, Patel S, Rubin EH, Ryden A, Soltys K, Sridhara R, Thanarajasingam G, Velikova G, Coons SJ. Kluetz PG, et al. Value Health. 2018 Jun;21(6):742-747. doi: 10.1016/j.jval.2017.09.009. Epub 2017 Nov 7. Value Health. 2018. PMID: 29909880 Free article.
Improving attribution of adverse events in oncology clinical trials.
George GC, Barata PC, Campbell A, Chen A, Cortes JE, Hyman DM, Jones L, Karagiannis T, Klaar S, Le-Rademacher JG, LoRusso P, Mandrekar SJ, Merino DM, Minasian LM, Mitchell SA, Montez S, O'Connor DJ, Pettit S, Silk E, Sloan JA, Stewart M, Takimoto CH, Wong GY, Yap TA, Cleeland CS, Hong DS. George GC, et al. Cancer Treat Rev. 2019 Jun;76:33-40. doi: 10.1016/j.ctrv.2019.04.004. Epub 2019 Apr 25. Cancer Treat Rev. 2019. PMID: 31108240 Review.
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