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Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension.
Calvert M, Kyte D, Mercieca-Bebber R, Slade A, Chan AW, King MT; the SPIRIT-PRO Group; Hunn A, Bottomley A, Regnault A, Chan AW, Ells C, O'Connor D, Revicki D, Patrick D, Altman D, Basch E, Velikova G, Price G, Draper H, Blazeby J, Scott J, Coast J, Norquist J, Brown J, Haywood K, Johnson LL, Campbell L, Frank L, von Hildebrand M, Brundage M, Palmer M, Kluetz P, Stephens R, Golub RM, Mitchell S, Groves T. Calvert M, et al. Among authors: johnson ll. JAMA. 2018 Feb 6;319(5):483-494. doi: 10.1001/jama.2017.21903. JAMA. 2018. PMID: 29411037 Free article.
Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials: Symptomatic Adverse Events, Physical Function, and Disease-Related Symptoms.
Kluetz PG, Slagle A, Papadopoulos EJ, Johnson LL, Donoghue M, Kwitkowski VE, Chen WH, Sridhara R, Farrell AT, Keegan P, Kim G, Pazdur R. Kluetz PG, et al. Among authors: johnson ll. Clin Cancer Res. 2016 Apr 1;22(7):1553-8. doi: 10.1158/1078-0432.CCR-15-2035. Epub 2016 Jan 12. Clin Cancer Res. 2016. PMID: 26758559
Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials-Response.
Kluetz PG, Papadopoulos EJ, Johnson LL, Donoghue M, Kwitkowski VE, Chen WH, Sridhara R, Farrell AT, Keegan P, Kim G, Pazdur R. Kluetz PG, et al. Among authors: johnson ll. Clin Cancer Res. 2016 Nov 15;22(22):5618. doi: 10.1158/1078-0432.CCR-16-2140. Clin Cancer Res. 2016. PMID: 28151715 Free PMC article. No abstract available.
Use of PRO Measures to Inform Tolerability in Oncology Trials: Implications for Clinical Review, IND Safety Reporting, and Clinical Site Inspections.
Kim J, Singh H, Ayalew K, Borror K, Campbell M, Johnson LL, Karesh A, Khin NA, Less JR, Menikoff J, Minasian L, Mitchell SA, Papadopoulos EJ, Piekarz RL, Prohaska KA, Thompson S, Sridhara R, Pazdur R, Kluetz PG. Kim J, et al. Among authors: johnson ll. Clin Cancer Res. 2018 Apr 15;24(8):1780-1784. doi: 10.1158/1078-0432.CCR-17-2555. Epub 2017 Dec 13. Clin Cancer Res. 2018. PMID: 29237718 Review.
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. Among authors: johnson ll. 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.
Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI): stakeholder views, objectives, and procedures.
Pe M, Alanya A, Falk RS, Amdal CD, Bjordal K, Chang J, Cislo P, Coens C, Dirven L, Speck RM, Fitzgerald K, Galinsky J, Giesinger JM, Holzner B, Le Cessie S, O'Connor D, Oliver K, Pawar V, Quinten C, Schlichting M, Ren J, Roychoudhury S, Taphoorn MJB, Velikova G, Wintner LM, Griebsch I, Bottomley A; SISAQOL-IMI Consortium. Pe M, et al. Lancet Oncol. 2023 Jun;24(6):e270-e283. doi: 10.1016/S1470-2045(23)00157-2. Lancet Oncol. 2023. PMID: 37269858 Free article. Review.
Regulatory news: Dojolvi (triheptanoin) as a source of calories and fatty acids in long-chain fatty acid oxidation disorders: FDA approval summary.
Zand D, Doan J, Yi S, Wang J, Ma L, Akinshola E, Chakder S, Meyer J, Pacanowski M, Johnson LL, Donohue K, Beitz J. Zand D, et al. Among authors: johnson ll. J Inherit Metab Dis. 2021 May;44(3):515-517. doi: 10.1002/jimd.12377. Epub 2021 Mar 25. J Inherit Metab Dis. 2021. PMID: 33729583 No abstract available.
387 results