The OCE PFDD program has published multiple manuscripts in peer-reviewed journals to advance patient-focused drug development. Some selected articles are listed below:

Floor and ceiling effects in the EORTC QLQ-C30 Physical Functioning Subscale among patients with advanced or metastatic breast cancer. Murugappan MN, King-Kallimanis BL, Mangir C, Howie L, Bhatnagar V, Beaver JA, Basch EM, Henson SR, Kluetz PG. Cancer. 2022 Feb 15;128(4):808-818.

US Food and Drug Administration Analysis of Patient-Reported Diarrhea and Its Impact on Function and Quality of Life in Patients Receiving Treatment for Breast Cancer. Chen TY, King-Kallimanis BL, Merzoug L, Horodniceanu EG, Fiero MH, Gao JJ, Beaver JA, Bhatnagar V, Kluetz P. Value in Health. 2022 Apr 1;25(4):566-70.

Time to deterioration of symptoms or function using patient-reported outcomes in cancer trials. Fiero MH, Roydhouse JK, Bhatnagar V, Chen TY, King-Kallimanis BL, Tang S, Kluetz PG. The Lancet Oncology. 2022 May 1;23(5):e229-34.

Timing is everything: The importance of patient-reported outcome assessment frequency when characterizing symptomatic adverse events. King-Kallimanis BL, Bhatnagar V, Horodniceanu EG, Chen TY, Kluetz PG. Clinical Trials. 2022 May 15:17407745221093935.

Encouraging Rigorous Patient-Generated Data All along the Drug Development Continuum. Bhatnagar V, Kluetz PG. JNCI: Journal of the National Cancer Institute. 2022 Jul 28.

FDA review summary of patient-reported outcome results for ibrutinib in the treatment of chronic graft versus host disease. King-Kallimanis, B.L., Wroblewski, T., Kwitkowski, V., De Claro, R.A., Gwise, T., Bhatnagar, V., et al. Qual. Life Res. 2020.

Patient‐Reported Outcomes in Oncology Clinical Trials: Stakeholder Perspectives from the Accelerating Anticancer Agent Development and Validation Workshop 2019. Bhatnagar, V., Hudgens, S., Piault-Louis, E., Jones, L., Beaver, J., Lyerly H.K., Reaman, G., Fleming, T., Kluetz, P. The Oncologist. 2020. 

Patient-Reported Outcomes in Anti-PD-1/PD-L1 Inhibitor Immunotherapy Registration Trials: FDA Analysis of Data Submitted and Future Directions. King-Kallimanis BL, Howie LJ, Roydhouse JK, Singh H, Theoret MR, Blumenthal GM, Kluetz PG. Clinical Trials. 2019. 

FDA Approval Summary: Pertuzumab for adjuvant treatment of HER2-positive early breast cancer. Howie LJ, Scher NS, Amiri-Kordestani L, Zhang L, King-Kallimanis BL, Choudhry Y, Schroeder J, Goldberg KB, Kluetz PG, Ibrahim A, Sridhara R, Blumenthal GM, Pazdur R, Beaver JA. Clin Cancer Res. 2018 Dec 14. pii: clincanres.3003.2018. 

Blinding and Patient-Reported Outcome Completion Rates in US Food and Drug Administration Cancer Trial Submissions, 2007-2017. Roydhouse JK, King-Kallimanis BL, Howie LJ, Singh H, Kluetz PG. J Natl Cancer Inst. 2018 Dec 17. 

Learning from Patients: Reflections on Use of Patient-Reported Outcomes in Lung Cancer Trials. Basu Roy U, King-Kallimanis BL, Kluetz PG, Selig W, Ferris A. J Thorac Oncol. 2018 Dec;13(12):1815-1817. 

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. 

Overview of Oncology and Hematology Drug Approvals at US Food and Drug Administration Between 2008 and 2016. Zhou J, Vallejo J, Kluetz P, Pazdur R, Kim T, Keegan P, Farrell A, Beaver JA, Sridhara R. J Natl Cancer Inst. 2018 Aug 4.

Metastasis-free Survival - A New End Point in Prostate Cancer Trials. Beaver JA, Kluetz PG, Pazdur R. N Engl J Med. 2018 Jun 28;378(26):2458-2460.

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. Value Health. 2018 Jun;21(6):742-747. 

Incorporating the patient experience into regulatory decision making in the USA, Europe, and Canada. Kluetz PG, O'Connor DJ, Soltys K. Lancet Oncol. 2018 May;19(5):e267-e274. 

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. JAMA. 2018 Feb 6;319(5):483-494.

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. Clin Cancer Res. 2018 Apr 15;24(8):1780-1784.

Commentary on Heath et al. Kwitkowski V, Daniels S, Reaman G, Farrell A, Kluetz P. Clin Trials. 2017 Dec;14(6):572-574.

Patient-Reported Outcomes in Cancer Clinical Trials: Measuring Symptomatic Adverse Events With the National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Kluetz PG, Chingos DT, Basch EM, Mitchell SA. Am Soc Clin Oncol Educ Book. 2016;35:67-73.

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.
Clin Cancer Res. 2016 Nov 15;22(22):5618. 

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 MJ, 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.

Looking to the future in an unprecedented time for cancer drug development. Kluetz PG, Pazdur R. Semin Oncol. 2016 Feb;43(1):2-3.

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. Clin Cancer Res. 2016 Apr 1;22(7):1553-8.

Patient-Reported Outcomes in Cancer Drug Development and US Regulatory Review: Perspectives From Industry, the Food and Drug Administration, and the Patient. Basch E, Geoghegan C, Coons SJ, Gnanasakthy A, Slagle AF, Papadopoulos EJ, Kluetz PG. JAMA Oncol. 2015 Jun;1(3):375-9.

Pain palliation measurement in cancer clinical trials: the US Food and Drug Administration perspective. Basch E, Trentacosti AM, Burke LB, Kwitkowski V, Kane RC, Autio KA, Papadopoulos E, Stansbury JP, Kluetz PG, Smith H, Justice R, Pazdur R. Cancer. 2014 Mar 1;120(5):761-7.