Sean Khozin
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View article: 1053 Shaping the future of immunotherapy safety through consensus—standardization of case report forms
1053 Shaping the future of immunotherapy safety through consensus—standardization of case report forms Open
View article: Towards a framework for a new research ecosystem
Towards a framework for a new research ecosystem Open
There is a substantial disconnect between theoretical recommendations for how much a nation should invest in science, innovation, and technology, and the practical challenges of implementing those investments. In this note, we identify fou…
View article: Real-World Evidence Acceptability and Use in Breast Cancer Treatment Decision-Making in the United States: Call-to-Action from a Multidisciplinary Think Tank
Real-World Evidence Acceptability and Use in Breast Cancer Treatment Decision-Making in the United States: Call-to-Action from a Multidisciplinary Think Tank Open
Complementing randomized controlled trials, real-world evidence (RWE) from observational analyses can extend clinical insights in oncology. While healthcare stakeholders have published rigorous RWE frameworks and resources, a multidiscipli…
View article: From organs to algorithms: Redefining cancer classification in the age of artificial intelligence
From organs to algorithms: Redefining cancer classification in the age of artificial intelligence Open
Traditional cancer classification based on organ of origin and histology is increasingly at odds with precision oncology. Tumors in different organs can share molecular features, while those in the same organ can be heterogeneous. This dis…
View article: Non-Obvious Alien AI Constructions: Opportunities and Implications
Non-Obvious Alien AI Constructions: Opportunities and Implications Open
This paper examines the utility and exploitation of non-obvious "alien" AI constructions, artificial intelligence solutions that significantly deviate from human intuition and traditional problem-solving approaches. It explores recent reve…
View article: Unleashing the power of clinical trial data: a proposal for enhancing informed consent and data sharing
Unleashing the power of clinical trial data: a proposal for enhancing informed consent and data sharing Open
Although clinical trial participants support data sharing, access to patient-level data remains limited. Innovative solutions are needed to ensure scientists can access the data from clinical trials. This commentary proposes a potential st…
View article: Towards a Framework for a New Research Ecosystem
Towards a Framework for a New Research Ecosystem Open
A major gap exists between the conceptual suggestion of how much a nation should invest in science, innovation, and technology, and the practical implementation of what is done. We identify 4 critical challenges that must be address in ord…
View article: IMMU-10. VISUALIZING GBM SUCCESS: SOC + TRIPLE-ARMED IMMUNOTHERAPY CASE REPORT--<i>FUTURE TRIAL DESIGN OPTIONS</i>
IMMU-10. VISUALIZING GBM SUCCESS: SOC + TRIPLE-ARMED IMMUNOTHERAPY CASE REPORT--<i>FUTURE TRIAL DESIGN OPTIONS</i> Open
Pro-neural GBM IV patient's family-guided, provider-consulted N-of-1 journey from SOC through development and implementation of a triple-armed personalized immunotherapy combination. No tumor progression observed 4-years post-diagnosis, 3-…
View article: Real-world evidence for regulatory decision-making: updated guidance from around the world
Real-world evidence for regulatory decision-making: updated guidance from around the world Open
Leveraging the value of real-world evidence (RWE) to make informed regulatory decisions in the field of health care continues to gain momentum. Improving clinical evidence generation by evaluating the outcomes and patient experiences at th…
View article: Data from <sup>18</sup>F-Fluorodeoxyglucose Positron Emission Tomography in the Management of Patients with Thymic Epithelial Tumors
Data from <sup>18</sup>F-Fluorodeoxyglucose Positron Emission Tomography in the Management of Patients with Thymic Epithelial Tumors Open
Purpose: There are limited data regarding the role of 18F-fluorodeoxyglucose positron emission tomography ([18F]-FDG PET) imaging in management of patients with thymic epithelial tumors (TET). The primary objec…
View article: Table A1: ICD-9-CM Neoplasm Terms for Lung Cancer from Impact of Broadening Trial Eligibility Criteria for Patients with Advanced Non–Small Cell Lung Cancer: Real-World Analysis of Select ASCO-<i>Friends</i> Recommendations
Table A1: ICD-9-CM Neoplasm Terms for Lung Cancer from Impact of Broadening Trial Eligibility Criteria for Patients with Advanced Non–Small Cell Lung Cancer: Real-World Analysis of Select ASCO-<i>Friends</i> Recommendations Open
Tables of ICD9 and ICD10 codes used.
View article: Data from <sup>18</sup>F-Fluorodeoxyglucose Positron Emission Tomography in the Management of Patients with Thymic Epithelial Tumors
Data from <sup>18</sup>F-Fluorodeoxyglucose Positron Emission Tomography in the Management of Patients with Thymic Epithelial Tumors Open
Purpose: There are limited data regarding the role of 18F-fluorodeoxyglucose positron emission tomography ([18F]-FDG PET) imaging in management of patients with thymic epithelial tumors (TET). The primary objec…
View article: Table A1: ICD-9-CM Neoplasm Terms for Lung Cancer from Impact of Broadening Trial Eligibility Criteria for Patients with Advanced Non–Small Cell Lung Cancer: Real-World Analysis of Select ASCO-<i>Friends</i> Recommendations
Table A1: ICD-9-CM Neoplasm Terms for Lung Cancer from Impact of Broadening Trial Eligibility Criteria for Patients with Advanced Non–Small Cell Lung Cancer: Real-World Analysis of Select ASCO-<i>Friends</i> Recommendations Open
Tables of ICD9 and ICD10 codes used.
View article: Data from Impact of Broadening Trial Eligibility Criteria for Patients with Advanced Non–Small Cell Lung Cancer: Real-World Analysis of Select ASCO-<i>Friends</i> Recommendations
Data from Impact of Broadening Trial Eligibility Criteria for Patients with Advanced Non–Small Cell Lung Cancer: Real-World Analysis of Select ASCO-<i>Friends</i> Recommendations Open
Purpose:Cancer clinical trials often accrue slowly or miss enrollment targets. Strict eligibility criteria are a major reason. Restrictive criteria also limit opportunities for patient participation while compromising external validity of …
View article: Supplementary Methods from <sup>18</sup>F-Fluorodeoxyglucose Positron Emission Tomography in the Management of Patients with Thymic Epithelial Tumors
Supplementary Methods from <sup>18</sup>F-Fluorodeoxyglucose Positron Emission Tomography in the Management of Patients with Thymic Epithelial Tumors Open
PDF file - 105K, Methodological details of 18F-FDG PET/CT image acquisition and analysis
View article: Supplementary Methods from <sup>18</sup>F-Fluorodeoxyglucose Positron Emission Tomography in the Management of Patients with Thymic Epithelial Tumors
Supplementary Methods from <sup>18</sup>F-Fluorodeoxyglucose Positron Emission Tomography in the Management of Patients with Thymic Epithelial Tumors Open
PDF file - 105K, Methodological details of 18F-FDG PET/CT image acquisition and analysis
View article: Data from Impact of Broadening Trial Eligibility Criteria for Patients with Advanced Non–Small Cell Lung Cancer: Real-World Analysis of Select ASCO-<i>Friends</i> Recommendations
Data from Impact of Broadening Trial Eligibility Criteria for Patients with Advanced Non–Small Cell Lung Cancer: Real-World Analysis of Select ASCO-<i>Friends</i> Recommendations Open
Purpose:Cancer clinical trials often accrue slowly or miss enrollment targets. Strict eligibility criteria are a major reason. Restrictive criteria also limit opportunities for patient participation while compromising external validity of …
View article: The design and evaluation of hybrid controlled trials that leverage external data and randomization
The design and evaluation of hybrid controlled trials that leverage external data and randomization Open
Patient-level data from completed clinical studies or electronic health records can be used in the design and analysis of clinical trials. However, these external data can bias the evaluation of the experimental treatment when the statisti…
View article: The Design and Evaluation of Hybrid Controlled Trials that Leverage External Data and Randomization
The Design and Evaluation of Hybrid Controlled Trials that Leverage External Data and Randomization Open
Patient-level data from completed clinical studies or electronic health records can be used in the design and analysis of clinical trials. However, these external data can bias the evaluation of the experimental treatment when the statisti…
View article: Immune-related adverse events associated with immune checkpoint inhibitors: a call to action for collecting and sharing clinical trial and real-world data
Immune-related adverse events associated with immune checkpoint inhibitors: a call to action for collecting and sharing clinical trial and real-world data Open
Immune checkpoint inhibitors (ICIs) have revolutionized the treatment of cancer, improving outcomes in patients with advanced malignancies. The use of ICIs in clinical practice, and the number of ICI clinical trials, are rapidly increasing…
View article: Impact of Broadening Trial Eligibility Criteria for Patients with Advanced Non–Small Cell Lung Cancer: Real-World Analysis of Select ASCO- <i>Friends</i> Recommendations
Impact of Broadening Trial Eligibility Criteria for Patients with Advanced Non–Small Cell Lung Cancer: Real-World Analysis of Select ASCO- <i>Friends</i> Recommendations Open
Purpose: Cancer clinical trials often accrue slowly or miss enrollment targets. Strict eligibility criteria are a major reason. Restrictive criteria also limit opportunities for patient participation while compromising external validity of…
View article: Pre-clinical animal models are poor predictors of human toxicities in phase 1 oncology clinical trials
Pre-clinical animal models are poor predictors of human toxicities in phase 1 oncology clinical trials Open
Background Our objective was to determine the correlation between preclinical toxicity found in animal models (mouse, rat, dog and monkey) and clinical toxicity reported in patients participating in Phase 1 oncology clinical trials. Method…
View article: Patient-Centered Approach to Benefit–Risk Characterization Using Number Needed to Benefit and Number Needed to Harm: Advanced Non–Small-Cell Lung Cancer
Patient-Centered Approach to Benefit–Risk Characterization Using Number Needed to Benefit and Number Needed to Harm: Advanced Non–Small-Cell Lung Cancer Open
This work summarizes the benefit and risk of the results of clinical trials submitted to the US Food and Drug Administration of therapies for the treatment of non–small cell lung cancer (NSCLC) using number needed to benefit (NNB) and numb…
View article: Status Update on Data Required to Build a Learning Health System
Status Update on Data Required to Build a Learning Health System Open
Wide adoption of electronic health records (EHRs) has raised the expectation that data obtained during routine clinical care, termed “real-world” data, will be accumulated across health care systems and analyzed on a large scale to produce…
View article: Author’s Response to “A Letter in Support of Real-World RECIST”
Author’s Response to “A Letter in Support of Real-World RECIST” Open
We appreciate the opportunity to discuss and clarify our findings [1].Although the letter authors' work complements our own [2][3][4][5], the objectives and the methods differ.For example, in Feinberg et al., Response Evaluation Criteria i…
View article: Association of programmed cell death 1 (PD-1) inhibitor therapy with overall survival (OS) in stage IV melanoma treated with targeted therapies
Association of programmed cell death 1 (PD-1) inhibitor therapy with overall survival (OS) in stage IV melanoma treated with targeted therapies Open
View article: Association Between FDA Label Restriction and Immunotherapy and Chemotherapy Use in Bladder Cancer
Association Between FDA Label Restriction and Immunotherapy and Chemotherapy Use in Bladder Cancer Open
This research letter discusses the association between label restrictions by the US Food and Drug Administration on first-line immunotherapy for advanced bladder cancer and subsequent changes in practice.
View article: Characterizing the Feasibility and Performance of Real-World Tumor Progression End Points and Their Association With Overall Survival in a Large Advanced Non–Small-Cell Lung Cancer Data Set
Characterizing the Feasibility and Performance of Real-World Tumor Progression End Points and Their Association With Overall Survival in a Large Advanced Non–Small-Cell Lung Cancer Data Set Open
PURPOSE Large, generalizable real-world data can enhance traditional clinical trial results. The current study evaluates reliability, clinical relevance, and large-scale feasibility for a previously documented method with which to characte…
View article: Real‐world progression, treatment, and survival outcomes during rapid adoption of immunotherapy for advanced non–small cell lung cancer
Real‐world progression, treatment, and survival outcomes during rapid adoption of immunotherapy for advanced non–small cell lung cancer Open
Background Despite the rapid adoption of immunotherapies in advanced non–small cell lung cancer (advNSCLC), knowledge gaps remain about their real‐world (rw) performance. Methods This retrospective, observational, multicenter analysis used…
View article: Artificial intelligence and machine learning in clinical development: a translational perspective
Artificial intelligence and machine learning in clinical development: a translational perspective Open
Future of clinical development is on the verge of a major transformation due to convergence of large new digital data sources, computing power to identify clinically meaningful patterns in the data using efficient artificial intelligence a…