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  1. Article ; Online: When less is more-reducing complexity in cancer trials.

    Patel, Timil H / Rivera, Donna R / Singh, Harpreet / Kluetz, Paul G

    The Lancet. Oncology

    2024  Volume 25, Issue 1, Page(s) 10–12

    MeSH term(s) Humans ; Neoplasms/drug therapy ; Neoplasms/genetics ; Clinical Trials as Topic
    Language English
    Publishing date 2024-01-05
    Publishing country England
    Document type Journal Article
    ZDB-ID 2049730-1
    ISSN 1474-5488 ; 1470-2045
    ISSN (online) 1474-5488
    ISSN 1470-2045
    DOI 10.1016/S1470-2045(23)00627-7
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    Zs.A 5696: Show issues Location:
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  2. Article ; Online: Encouraging Rigorous Patient-Generated Data All Along the Drug Development Continuum.

    Bhatnagar, Vishal / Kluetz, Paul G

    Journal of the National Cancer Institute

    2022  Volume 114, Issue 10, Page(s) 1313–1314

    MeSH term(s) Continuity of Patient Care ; Drug Development ; Humans ; Neoplasms/drug therapy
    Language English
    Publishing date 2022-07-28
    Publishing country United States
    Document type Editorial ; Comment
    ZDB-ID 2992-0
    ISSN 1460-2105 ; 0027-8874 ; 0198-0157
    ISSN (online) 1460-2105
    ISSN 0027-8874 ; 0198-0157
    DOI 10.1093/jnci/djac129
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    Uh III Zs.131: Show issues Location:
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  3. Article: The FDA's patient-focused drug development initiative.

    Kluetz, Paul G / Bhatnagar, Vishal

    Clinical advances in hematology & oncology : H&O

    2021  Volume 19, Issue 2, Page(s) 70–72

    MeSH term(s) Antineoplastic Agents/therapeutic use ; Clinical Trials as Topic/methods ; Congresses as Topic ; Drug Development/organization & administration ; Drug Industry ; Health Policy ; Humans ; Intersectoral Collaboration ; Medical Oncology ; Neoplasms/drug therapy ; Neoplasms/psychology ; Patient Advocacy ; Patient Preference ; Patient-Centered Care/organization & administration ; United States ; United States Food and Drug Administration/organization & administration
    Chemical Substances Antineoplastic Agents
    Language English
    Publishing date 2021-03-09
    Publishing country United States
    Document type Interview
    ZDB-ID 2271951-9
    ISSN 1543-0790
    ISSN 1543-0790
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    Zs.A 6505: Show issues Location:
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  4. Article ; Online: Blurring the Lines of Design: Prospective Observational Cohorts and Pragmatic Clinical Trials Characterizing Treatment Effects in Routine Cancer Care.

    Rivera, Donna R / Larkins, Erin / Kluetz, Paul G

    The oncologist

    2022  Volume 27, Issue 2, Page(s) 79–81

    MeSH term(s) Humans ; Neoplasms/therapy ; Research Design
    Language English
    Publishing date 2022-05-31
    Publishing country England
    Document type Journal Article ; Observational Study ; Comment
    ZDB-ID 1409038-7
    ISSN 1549-490X ; 1083-7159
    ISSN (online) 1549-490X
    ISSN 1083-7159
    DOI 10.1093/oncolo/oyab071
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    Zs.A 4845: Show issues Location:
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    Zs.MO 494: Show issues

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  5. Article ; Online: Correlations of response rate and progression-free survival with overall survival in immunotherapy trials for metastatic non-small-cell lung cancer: an FDA pooled analysis.

    Goulart, Bernardo Haddock Lobo / Mushti, Sirisha L / Chatterjee, Somak / Larkins, Erin / Mishra-Kalyani, Pallavi S / Pazdur, Richard / Kluetz, Paul G / Singh, Harpreet

    The Lancet. Oncology

    2024  Volume 25, Issue 4, Page(s) 455–462

    Abstract: Background: Radiographic changes might not fully capture the treatment effects of immune checkpoint inhibitors (ICIs). We aimed to assess correlations of overall response rate and progression-free survival with overall survival in trials of ICIs for ... ...

    Abstract Background: Radiographic changes might not fully capture the treatment effects of immune checkpoint inhibitors (ICIs). We aimed to assess correlations of overall response rate and progression-free survival with overall survival in trials of ICIs for metastatic non-small-cell lung cancer (NSCLC).
    Methods: To assess trial-level and patient-level correlations of overall response rate and progression-free survival with overall survival, we conducted a pooled analysis of first-line randomised trials (including patients aged ≥18 years with metastatic squamous and non-squamous NSCLC and an Eastern Cooperative Oncology Group performance status of 0-1) submitted to the US Food and Drug Administration from June 24, 2016, to March 16, 2021. Eligible trials evaluated at least one ICI in the experimental group versus chemotherapy in the control group. At the trial level, we used weighted linear regression to derive coefficients of determination (R
    Findings: A total of 13 trials including 9285 patients evaluated ICIs alone or in combination with chemotherapy versus chemotherapy alone. At the trial level, the R
    Interpretation: Correlations of overall response rate and progression-free survival with overall survival were generally moderate in this pooled analysis. The findings support routine analysis of mature overall survival data, where feasible, in first-line randomised trials of ICIs for metastatic NSCLC.
    Funding: US Food and Drug Administration.
    MeSH term(s) Humans ; Adolescent ; Adult ; Carcinoma, Non-Small-Cell Lung/drug therapy ; Progression-Free Survival ; Lung Neoplasms/drug therapy ; Immunotherapy ; Antineoplastic Combined Chemotherapy Protocols/adverse effects
    Language English
    Publishing date 2024-03-05
    Publishing country England
    Document type Journal Article
    ZDB-ID 2049730-1
    ISSN 1474-5488 ; 1470-2045
    ISSN (online) 1474-5488
    ISSN 1470-2045
    DOI 10.1016/S1470-2045(24)00040-8
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    Zs.MO 460: Show issues

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  6. Article ; Online: FDA Oncology Center of Excellence Review Processes and Tools.

    Gao, Jennifer J / Kluetz, Paul G / Pazdur, Richard

    Clinical pharmacology and therapeutics

    2020  Volume 108, Issue 3, Page(s) 428–429

    MeSH term(s) Antineoplastic Agents/adverse effects ; Antineoplastic Agents/therapeutic use ; Drug Approval ; Humans ; Medical Oncology ; Patient Safety ; Risk Assessment ; Treatment Outcome ; United States ; United States Food and Drug Administration
    Chemical Substances Antineoplastic Agents
    Language English
    Publishing date 2020-07-12
    Publishing country United States
    Document type Journal Article
    ZDB-ID 123793-7
    ISSN 1532-6535 ; 0009-9236
    ISSN (online) 1532-6535
    ISSN 0009-9236
    DOI 10.1002/cpt.1945
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    Zs.A 20: Show issues Location:
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  7. Article ; Online: Call to Action for Improving Oral Anticancer Agent Adherence.

    Levit, Laura A / Arora, Shaily / Kluetz, Paul G / Magnuson, Allison / Rahman, Atiqur / Harvey, R Donald

    Journal of clinical oncology : official journal of the American Society of Clinical Oncology

    2022  Volume 40, Issue 10, Page(s) 1036–1040

    MeSH term(s) Administration, Oral ; Antineoplastic Agents/adverse effects ; Humans ; Medication Adherence ; Neoplasms/drug therapy
    Chemical Substances Antineoplastic Agents
    Language English
    Publishing date 2022-01-06
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 604914-x
    ISSN 1527-7755 ; 0732-183X
    ISSN (online) 1527-7755
    ISSN 0732-183X
    DOI 10.1200/JCO.21.02529
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    Zs.A 1847: Show issues Location:
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    Zs.MO 650: Show issues

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  8. Article ; Online: Timing is everything: The importance of patient-reported outcome assessment frequency when characterizing symptomatic adverse events.

    King-Kallimanis, Bellinda L / Bhatnagar, Vishal / Horodniceanu, Erica G / Chen, Ting-Yu / Kluetz, Paul G

    Clinical trials (London, England)

    2022  Volume 19, Issue 3, Page(s) 267–273

    Abstract: Objective: Although patient-reported symptoms and side effects are increasingly measured in cancer clinical trials, an appropriate assessment frequency has not yet been established. To determine whether differences in assessment frequency affect the ... ...

    Abstract Objective: Although patient-reported symptoms and side effects are increasingly measured in cancer clinical trials, an appropriate assessment frequency has not yet been established. To determine whether differences in assessment frequency affect the apparent incidence and severity of patient-reported symptoms using two well-established patient-reported outcome measures used within the same clinical trial.
    Methods: We examined patient-reported outcome results from AURA3 (NCT02151981), a randomized open-label study comparing Tagrisso (osimertinib) with platinum-based chemotherapy in patients with previously treated estimated glomerular filtration rate/T790M mutation-positive metastatic non-small cell lung cancer. The outcome of interest was the proportion of patients in each arm that reported worsening of nausea, vomiting, fatigue, diarrhea, constipation, and appetite loss from baseline measured using the patient-reported outcome-common terminology criteria for adverse event (weekly) or European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (every 6 weeks).
    Results: Similar trends were observed for all six symptoms investigated. Using nausea in the chemotherapy arm as an example, 76% of patients reported any worsening from baseline based on weekly patient-reported outcome-common terminology criteria for adverse event assessments. When using an every 6-week assessment of Quality of Life Questionnaire Core 30 nausea and restricting analysis to an every 6-week assessment for patient-reported outcome-common terminology criteria for adverse event nausea, the proportion of chemotherapy arm patients reporting any worsening of nausea was 40% for both measures. Across the six patient-reported symptomatic adverse events, we observed differential proportions when comparing frequent versus sparse assessment.
    Conclusion: This analysis demonstrates that more frequent assessment of patient-reported symptomatic adverse events will lead to improved detection, and therefore a more complete understanding of the tolerability of experimental anti-cancer therapies.
    MeSH term(s) Carcinoma, Non-Small-Cell Lung/drug therapy ; ErbB Receptors/genetics ; ErbB Receptors/therapeutic use ; Humans ; Lung Neoplasms/drug therapy ; Mutation ; Nausea/chemically induced ; Patient Reported Outcome Measures ; Protein Kinase Inhibitors/therapeutic use ; Quality of Life
    Chemical Substances Protein Kinase Inhibitors ; ErbB Receptors (EC 2.7.10.1)
    Language English
    Publishing date 2022-05-15
    Publishing country England
    Document type Journal Article ; Randomized Controlled Trial
    ZDB-ID 2138796-5
    ISSN 1740-7753 ; 1740-7745
    ISSN (online) 1740-7753
    ISSN 1740-7745
    DOI 10.1177/17407745221093935
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    Zs.A 5831: Show issues Location:
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  9. Article ; Online: Landscape Analysis of Generic Availability for Oncologic Drugs.

    Kumar, Vaibhav / Wang, Fenggong / Hu, Meng / Kluetz, Paul / Zhao, Liang

    Therapeutic innovation & regulatory science

    2023  Volume 57, Issue 6, Page(s) 1279–1286

    Abstract: ... selection was used to identify variables (e.g., regulatory recommendation issued, dosage form) that were ...

    Abstract Background: Improving generic drug development in oncology is a key long-term goal in providing safe, effective, and affordable care to patients with a diagnosis of cancer in the United States. There are multiple drug and non-drug related variables that may influence generic drug development. To illustrate pertinent associations relevant to generic drug competition in oncology, our study assessed variables that have potentially led to difference in generic competition as compared to drug products in other therapeutic areas, i.e., cardiovascular disease in this case.
    Methods: Using a combination of FDA and publicly available data, we categorized individual drug approvals from 1950 to 2021 with either an oncology or cardiovascular indication. Descriptive statistics highlighted the timeline of approval as stratified by indications. Machine learning methodology was used to assess variables associated with abbreviated new drug application (ANDA) availabilities (i.e., generic drug availabilities). Kaplan-Meier analysis with log-rank test compared the difference in the time to approval of first ANDA among products that were off-patent at the time of analysis. A multivariable Cox proportional hazards model with forward selection was used to identify variables (e.g., regulatory recommendation issued, dosage form) that were associated with ANDA availability among products that were off-patent.
    Results: 434 separate reference listed drugs (RLDs) with varying strengths were identified, 212 (49%) for oncology and 222 (51%) for cardiovascular indications. Compared with cardiovascular products, a greater proportion of RLDs with an oncology indication were approved after 2000 (61% vs. 34%). Also, a smaller proportion of oncologic products had generics (49% vs. 80%). Machine learning methodology revealed RLD age, patent status, product complexity, sales/prescriptions, and regulatory recommendations as variables that were associated with generic availability. Among products off-patent at the time of analysis, the median time from RLD approval to the first ANDA approval was longer for oncologic products compared to cardiovascular products (15.4 years (95% CI 13.8, 17.9) versus 12.3 years (95% CI 10.7, 13.5), p = 0.008). Cox regression analyses identified the variables of product dosage form and regulatory recommendation of requiring patient enrollment for bioequivalence (BE) establishment as being associated with reduced likelihood of ANDA approval for oncologic drugs.
    Conclusion: Oncology indications were found to have a longer time from RLD approval to first ANDA approval compared with cardiovascular drugs. Our work has identified variables that may influence time to ANDA availability, with the requirement of patient enrollment for BE assessment as one important opportunity for future stakeholder engagement and regulatory considerations.
    MeSH term(s) Humans ; United States ; Drugs, Generic ; United States Food and Drug Administration ; Drug Approval ; Therapeutic Equivalency ; Neoplasms/drug therapy
    Chemical Substances Drugs, Generic
    Language English
    Publishing date 2023-08-10
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2708397-4
    ISSN 2168-4804 ; 2168-4790
    ISSN (online) 2168-4804
    ISSN 2168-4790
    DOI 10.1007/s43441-023-00562-w
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  10. Article ; Online: Considering Functional Outcomes as Efficacy Endpoints in Pediatric Low-Grade Glioma Clinical Trials: An FDA Educational Symposium.

    Fangusaro, Jason / Avery, Robert A / Fisher, Michael J / Packer, Roger J / Walsh, Karin S / Schouten-van Meeteren, Antoinette / Karres, Dominik / Bradford, Diana / Bhatnagar, Vishal / Singh, Harpreet / Kluetz, Paul G / Donoghue, Martha / Duke, Elizabeth S

    Clinical cancer research : an official journal of the American Association for Cancer Research

    2024  

    Abstract: In October 2022, the Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) hosted an educational symposium entitled, "Considering Functional Outcomes as Efficacy Endpoints in Pediatric Low-Grade Glioma (pLGG) Clinical Trials." The ... ...

    Abstract In October 2022, the Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) hosted an educational symposium entitled, "Considering Functional Outcomes as Efficacy Endpoints in Pediatric Low-Grade Glioma (pLGG) Clinical Trials." The symposium brought together patient advocates, regulators from the FDA and the European Medicines Agency (EMA), and an international group of academic thought leaders in the field of pediatric neuro-oncology to discuss the potential role of functional outcomes, including visual acuity, motor function, and neurocognitive performance, as endpoints in clinical trials enrolling patients with pLGG. The panel discussed challenges and opportunities regarding the selection, implementation, and evaluation of clinical outcome assessments in these functional domains and outlined key considerations for their inclusion in future clinical trial design and role in new drug development.
    Language English
    Publishing date 2024-02-15
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1225457-5
    ISSN 1557-3265 ; 1078-0432
    ISSN (online) 1557-3265
    ISSN 1078-0432
    DOI 10.1158/1078-0432.CCR-23-3386
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