Vishal Bhatnagar, M.D.
Oncology Center of Excellence

Vishal Bhatnagar, MD, is a medical oncologist/hematologist and the Associate Director for Patient Outcomes in the OCE. His interests include patient reported outcomes, patient preference and incorporation of patient experience in oncology trials. His work focuses on the operational management of the OCE’s Patient-Focused Drug Development program. Additionally, Dr. Bhatnagar has a strong clinical interest in multiple myeloma and has previously served as an Office of Hematology and Oncology multiple myeloma scientific liaison. Dr. Bhatnagar received his BA in Political Science and his medical degree at the George Washington University. He completed his internal medicine residency and hematology/oncology fellowship at the University of Maryland.

Paul G. Kluetz, M.D.
Oncology Center of Excellence

Paul Kluetz is a medical oncologist and the Deputy Director of the Oncology Center of Excellence at the U.S. FDA. In addition to his broader role in OCE’s strategic oversight and management, Dr. Kluetz founded the OCE’s PFDD program and continues to support its strategic mission. He has engaged the global cancer drug development and health outcomes community in leading a sustained effort to advance patient reported outcomes (PRO) data, wearable technologies, and other methods to obtain rigorous patient experience data in both the clinical trial and “real-world” settings.

Projects

• Collaborator: Kaiser Permanente, Division of Research – PANcreatic cancer Patient Reported Outcomes using the Electronic medical record (PanPROE)
• Collaborator: Northwestern University and University of Tasmania – Evaluation of a global item for side effect bother
• Collaborator: Duke University - Evaluating physical functioning using patient-reported outcome measures: How does the question form and recall period influence patients’ interpretation?
• Collaborator: Mayo Clinic and Yale University - Quantifying physical function in cancer patients undergoing chemotherapy using clinician- and patient-reports along with wearable device data
• Collaborator: Mayo Clinic and Yale University - Longitudinal analysis & visualization of patient-reported physical function & symptom data
• Collaborator: Mayo Clinic and Yale University - Qualitative techniques to define meaningful within-patient change in symptoms of advanced cancer patients
• Collaborator: National Cancer Institute– Advancing the use of digital health technologies and digital symptom reporting for patient-reported outcome measures

Working Groups

• National Cancer Institute (NCI) Cancer Moonshot Tolerability Consortium Steering Committee
• Patient-Reported Outcomes Tools: Engaging Users & Stakeholders (PROTEUS) consortium
• Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) 
• Standard Protocol Items: Recommendations for Interventional Trials Patient-Reported Outcomes (SPIRIT-PRO)

Upcoming Events:

2025: 10th Clinical Outcomes Assessment in Cancer Clinical Trials (COA-CCT) Workshop. Date TBD

Past Events:

Clinical Outcomes Assessment in Clinical Cancer Trials (COA-CCT) Workshops

June 25, 2024: 9th COA-CCT Workshop

June 27, 2023: 8th COA-CCT Workshop 

June 29, 2022: 7th COA-CCT Workshop 

July 21 and 23, 2021: 6th COA-CCT Workshop

July 17, 2020: 5th COA-CCT Workshop with American Society of Clinical Oncology 

July 12, 2019: 4th COA-CCT Workshop with American Society of Clinical Oncology 

June 22, 2018: 3rd COA-CCT Workshop with American Society for Clinical Oncology 

April 25, 2017: 2nd COA-CCT Workshop with the Critical Path InstituteExternal Link Disclaimer

April 26, 2016: COA-CCT Workshop with the Critical Path InstituteExternal Link Disclaimer 

Other Events

May 11-12, 2021: Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee

October 8, 2019: 3rd Partners in Progress

November 27, 2018: 2nd Partners in Progress

November 13, 2017: 1st Partners in Progress

The OCE PFDD Program continuously publishes on topics to advance patient-focused drug development. Recent articles are listed below:

Murugappan MN, King-Kallimanis BL, Bhatnagar V, Kanapuru B, Farley JF, Seifert RD, et al. Measuring Frailty Using Patient-Reported Outcomes (PRO) Data: A Feasibility Study in Patients with Multiple MyelomaExternal Link Disclaimer. Quality of Life Research. 2023 Mar 20:1-2.

Thanarajasingam G, Kluetz PG, Bhatnagar V, Brown A, Cathcart-Rake E, Diamond M, et al. Integrating 4 Measures to Evaluate Physical Function in Patients with Cancer (In4M): Protocol for a prospective studyExternal Link Disclaimer. medRxiv. 2023 Mar 9.

Piccinin C, Basch E, Bhatnagar V, Calvert M, Campbell A, Cella D, et al. Recommendations on the use of item libraries for patient-reported outcome measurement in oncology trials: findings from an international, multidisciplinary working groupExternal Link Disclaimer. The Lancet Oncology. 2023 Feb 1;24(2):e86-95.

Bhatnagar V, Dutcus C, Ghiorghiu S, Kluetz P, Jones L, McJunkins KR, et al. Supporting a Patient-Centric Approach to Dose Optimization in Oncology: The Essential Role of Patient-Reported Outcomes (PROs)External Link Disclaimer. Friends of Cancer Research White Paper. 2022.

Bhatnagar V, Kluetz PG. Encouraging Rigorous Patient-Generated Data All Along the Drug Development ContinuumExternal Link Disclaimer. Journal of the National Cancer Institute. 2022 Oct;114(10):1313-4.

King-Kallimanis BL, Bhatnagar V, Horodniceanu EG, Chen TY, Kluetz PG. Timing is everything: The importance of patient-reported outcome assessment frequency when characterizing symptomatic adverse eventsExternal Link Disclaimer. Clinical Trials. 2022 Jun;19(3):267-73.

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

Chen TY, King-Kallimanis BL, Merzoug L, Horodniceanu EG, Fiero MH, Gao JJ, et al. 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 CancerExternal Link Disclaimer. Value in Health. 2022 Apr 1;25(4):566-70. 

Murugappan MN, King‐Kallimanis BL, Mangir C, Howie L, Bhatnagar V, Beaver JA, et al. Floor and ceiling effects in the EORTC QLQ‐C30 Physical Functioning subscale among patients with advanced or metastatic breast cancerExternal Link Disclaimer. Cancer. 2022 Feb 15;128(4):808-18. 

Murugappan MN, King-Kallimanis BL, Reaman GH, Bhatnagar V, Horodniceanu EG, Bouchkouj N, et al. Patient-reported outcomes in pediatric cancer registration trials: A US Food and Drug Administration perspectiveExternal Link Disclaimer. JNCI: Journal of the National Cancer Institute. 2022 Jan;114(1):12-9.

King-Kallimanis BL, Lederer NM, Kim J, Nair A, Horodniceanu E, Bhatnagar V, et al. Patient-reported outcomes after treatment discontinuation: commercial clinical trial data from four cancer typesExternal Link Disclaimer. Value in Health. 2021 Sep 1;24(9):1302-7.

Fernandes LL, Zhou J, Kanapuru B, Horodniceanu E, Gwise T, Kluetz PG, et al. Review of patient-reported outcomes in multiple myeloma registrational trials: highlighting areas for improvementExternal Link Disclaimer. Blood Cancer Journal. 2021 Aug 31;11(8):148.

Calvert M, King M, Mercieca-Bebber R, Aiyegbusi O, Kyte D, Slade A, et al. SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trialsExternal Link Disclaimer. BMJ open. 2021 Jun 1;11(6):e045105.

Roydhouse JK, Mishra-Kalyani PS, Bhatnagar V, Gutman R, King-Kallimanis BL, Sridhara R, et al. Does knowledge of treatment assignment affect patient report of symptoms, function, and health status? An evaluation using multiple myeloma trialsExternal Link Disclaimer. Value in Health. 2021 Jun 1;24(6):822-9.

Kluetz PG, King-Kallimanis BL, Suzman D, Chang E, Brave MM, Weinstock C, et al. Advancing assessment, analysis, and reporting of safety and tolerability in cancer trialsExternal Link Disclaimer. JNCI: Journal of the National Cancer Institute. 2021 May;113(5):507-8. 

Kluetz PG, Bhatnagar V. The FDA's patient-focused drug development initiativeExternal Link Disclaimer. Clinical Advances in Hematology & Oncology: H&O. 2021 Feb 1;19(2):70-2.

Bhatnagar V, Hudgens S, Piault‐Louis E, Jones L, Beaver JA, Lyerly HK, et al. Patient‐reported outcomes in oncology clinical trials: Stakeholder perspectives from the accelerating anticancer agent development and validation workshop 2019External Link Disclaimer. The Oncologist. 2020 Oct;25(10):819-21.

Roydhouse JK, King-Kallimanis BL, Roy P, Weinstock C, Krol D, Daniels SR, et al. Exploration of baseline patient-reported side effect bother from cancer therapyExternal Link Disclaimer. Clinical Trials. 2020 Jun;17(3):332-7.

Roydhouse JK, Gutman R, Bhatnagar V, Kluetz PG, Sridhara R, Mishra‐Kalyani PS. Analyzing patient‐reported outcome data when completion differs between arms in open‐label trials: an application of principal stratificationExternal Link Disclaimer. Pharmacoepidemiology and Drug Safety. 2019 Oct;28(10):1386-94.

King-Kallimanis BL, Howie LJ, Roydhouse JK, Singh H, Theoret MR, Blumenthal GM, et al. Patient reported outcomes in anti-PD-1/PD-L1 inhibitor immunotherapy registration trials: FDA analysis of data submitted and future directionsExternal Link Disclaimer. Clinical Trials. 2019 Jun;16(3):322-6. 

Roydhouse JK, King-Kallimanis BL, Howie LJ, Singh H, Kluetz PG. Blinding and patient-reported outcome completion rates in US food and drug administration cancer trial submissions, 2007–2017External Link Disclaimer. JNCI: Journal of the National Cancer Institute. 2019 May 1;111(5):459-64. 

Roydhouse JK, Fiero MH, Kluetz PG. Investigating potential bias in patient-reported outcomes in open-label cancer trialsExternal Link Disclaimer. JAMA oncology. 2019 Apr 1;5(4):457-8.

Kluetz PG, Kanapuru B, Lemery S, Johnson LL, Fiero MH, Arscott K, et al. Informing the tolerability of cancer treatments using patient-reported outcome measures: summary of an FDA and critical path institute workshopExternal Link Disclaimer. Value in Health. 2018 Jun 1;21(6):742-7.

Kluetz PG, O'Connor DJ, Soltys K. Incorporating the patient experience into regulatory decision making in the USA, Europe, and CanadaExternal Link Disclaimer. The Lancet Oncology. 2018 May 1;19(5):e267-74.

Kim J, Singh H, Ayalew K, Borror K, Campbell M, Johnson LL, et al. Use of PRO Measures to Inform Tolerability in Oncology Trials: Implications for Clinical Review, IND Safety Reporting, and Clinical Site InspectionsExternal Link Disclaimer. Clinical Cancer Research. 2018 Apr 15;24(8):1780-4.

Kluetz PG, Chingos DT, Basch EM, Mitchell SA. 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)External Link Disclaimer. American Society of Clinical Oncology Educational Book. 2016 May;36:67-73.

Kluetz PG, Slagle A, Papadopoulos EJ, Johnson LL, Donoghue M, Kwitkowski VE, et al. Focusing on core patient-reported outcomes in cancer clinical trials: symptomatic adverse events, physical function, and disease-related symptomsExternal Link Disclaimer. Clinical Cancer Research. 2016 Apr 1;22(7):1553-8.