Articles, Presentations and Publications

Articles

Presentations

Presentation: Quality of Life in Cancer Clinical Trials at 5th EORTC Quality of Life in Cancer Clinical Trials Conference, Brussels, Belgium May 16-17, 2019

Meeting information: FDA Public Meeting on Benefit-Risk Assessments in Drug Regulatory Decision-Making

Presentation: Alicyn’s presentation starts at slide 232

Meeting Information: 2018 FDA / ASCO Oncology COA Meeting

Presentation: during Session 2: How to Measure: Case Based Examples of PRO Strategies

Meeting information: Patient-Focused Drug Development Guidance: Methods to Identify What is Important to Patients and Select, Develop or Modify Fit-for-Purpose Clinical Outcome Assessments

Presentation: Panel session 4, starts at slide 84

Online: Webcast part 3

Meeting Information: 2016 FDA/ C-Path Clinical Outcomes Assessments in Cancer Meeting

Presentation: Industry Example of Successful Instrument Modification (Starts at Slide 30)

recent Publications

Improving attribution of adverse events in oncology clinical trials

Goldy C.George, Pedro C.Barata, Alicyn Campbell, et al

Cancer Treatment Reviews. Volume 76, June 2019, Pages 33-40. https://doi.org/10.1016/j.ctrv.2019.04.004 Epub 25 April 2019

Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events: Methods for item selection in industry-sponsored oncology clinical trials.

Trask PC, Dueck AC, Piault E, Campbell A.

Clin Trials. 2018 Dec;15(6):616-623. doi: 10.1177/1740774518799985. Epub 2018 Sep 19.

Statistical analysis of patient-reported outcome data in randomised controlled trials of locally advanced and metastatic breast cancer: a systematic review.

Pe M, Dorme L, Coens C, Basch E, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Dirven L, Dueck AC, Devlin N, Flechtner HH, Gotay C, Griebsch I, Groenvold M, King M, Koller M, Malone DC, Martinelli F, Mitchell SA, Musoro JZ, Oliver K, Piault-Louis E, Piccart M, Pimentel FL, Quinten C, Reijneveld JC, Sloan J, Velikova G, Bottomley A; Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data Consortium (SISAQOL).

Lancet Oncol. 2018 Sep;19(9):e459-e469. doi: 10.1016/S1470-2045(18)30418-2. Review.

Moving forward toward standardizing analysis of quality of life data in randomized cancer clinical trials.

Bottomley A, Pe M, Sloan J, Basch E, Bonnetain F, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Dueck AC, Devlin N, Flechtner HH, Gotay C, Greimel E, Griebsch I, Groenvold M, Hamel JF, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Moinpour CM, Musoro JZ, O'Connor D, Oliver K, Piault-Louis E, Piccart M, Pimentel FL, Quinten C, Reijneveld JC, Schürmann C, Smith AW, Soltys KM, Sridhara R, Taphoorn MJB, Velikova G, Coens C.

Clin Trials. 2018 Dec;15(6):624-630. doi: 10.1177/1740774518795637. Epub 2018 Aug 24.

Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials: a start in setting international standards.

Bottomley A, Pe M, Sloan J, Basch E, Bonnetain F, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Dueck AC, Devlin N, Flechtner HH, Gotay C, Greimel E, Griebsch I, Groenvold M, Hamel JF, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Moinpour CM, Musoro J, O'Connor D, Oliver K, Piault-Louis E, Piccart M, Pimentel FL, Quinten C, Reijneveld JC, Schürmann C, Smith AW, Soltys KM, Taphoorn MJB, Velikova G, Coens C; Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) consortium.

Lancet Oncol. 2016 Nov;17(11):e510-e514. doi: 10.1016/S1470-2045(16)30510-1. Epub 2016 Oct 18. Review.

Validation of a treatment satisfaction questionnaire in non-Hodgkin lymphoma: assessing the change from intravenous to subcutaneous administration of rituximab.

Theodore-Oklota C, Humphrey L, Wiesner C, Schnetzler G, Hudgens S, Campbell A.

Patient Prefer Adherence. 2016 Sep 13;10:1767-1776. eCollection 2016.

Safety and efficacy of dacomitinib in korean patients with KRAS wild-type advanced non-small-cell lung cancer refractory to chemotherapy and erlotinib or gefitinib: a phase I/II trial.

Park K, Cho BC, Kim DW, Ahn MJ, Lee SY, Gernhardt D, Taylor I, Campbell AK, Zhang H, Giri N, Letrent SP, O'Connell J, Heo DS.

J Thorac Oncol. 2014 Oct;9(10):1523-31. doi: 10.1097/JTO.0000000000000275.

A phase 2 trial of dacomitinib (PF-00299804), an oral, irreversible pan-HER (human epidermal growth factor receptor) inhibitor, in patients with advanced non-small cell lung cancer after failure of prior chemotherapy and erlotinib.

Reckamp KL, Giaccone G, Camidge DR, Gadgeel SM, Khuri FR, Engelman JA, Koczywas M, Rajan A, Campbell AK, Gernhardt D, Ruiz-Garcia A, Letrent S, Liang J, Taylor I, O'Connell JP, Jänne PA.

Cancer. 2014 Apr 15;120(8):1145-54. doi: 10.1002/cncr.28561. Epub 2014 Feb 5.

Rittmeyer A, Gorbunova V, Vikström A, Scherpereel A, Kim JH, Ahn MJ, Chella A, Chouaid C, Campbell AK, Barlesi F.

J Thorac Oncol. 2013 Nov;8(11):1409-16. doi: 10.1097/JTO.0b013e3182a46bcf.

Randomized phase II study of dacomitinib (PF-00299804), an irreversible pan-human epidermal growth factor receptor inhibitor, versus erlotinib in patients with advanced non-small-cell lung cancer.

Ramalingam SS, Blackhall F, Krzakowski M, Barrios CH, Park K, Bover I, Seog Heo D, Rosell R, Talbot DC, Frank R, Letrent SP, Ruiz-Garcia A, Taylor I, Liang JQ, Campbell AK, O'Connell J, Boyer M.

J Clin Oncol. 2012 Sep 20;30(27):3337-44. doi: 10.1200/JCO.2011.40.9433. Epub 2012 Jul 2.