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  1. Article ; Online: Efficiency of Biomarker-Driven Clinical Trial Designs.

    Freidlin, Boris / Korn, Edward L

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

    2024  Volume 42, Issue 12, Page(s) 1454–1455

    MeSH term(s) Humans ; Clinical Trials as Topic ; Biomarkers, Tumor ; Research Design
    Chemical Substances Biomarkers, Tumor
    Language English
    Publishing date 2024-03-04
    Publishing country United States
    Document type Letter
    ZDB-ID 604914-x
    ISSN 1527-7755 ; 0732-183X
    ISSN (online) 1527-7755
    ISSN 0732-183X
    DOI 10.1200/JCO.23.02581
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  2. Article ; Online: Time trends with response-adaptive randomization: The inevitability of inefficiency.

    Korn, Edward L / Freidlin, Boris

    Clinical trials (London, England)

    2022  Volume 19, Issue 2, Page(s) 158–161

    Abstract: Response-adaptive randomization, which changes the randomization ratio as a randomized clinical trial progresses, is inefficient as compared to a fixed 1:1 randomization ratio in terms of increased required sample size. It is also known that response- ... ...

    Abstract Response-adaptive randomization, which changes the randomization ratio as a randomized clinical trial progresses, is inefficient as compared to a fixed 1:1 randomization ratio in terms of increased required sample size. It is also known that response-adaptive randomization leads to biased treatment effects if there are time trends in the accruing outcome data, for example, due to changes in the patient population being accrued, evaluation methods, or concomitant treatments. Response-adaptive-randomization analysis methods that account for potential time trends, such as time-block stratification or re-randomization, can eliminate this bias. However, as shown in this Commentary, these analysis methods cause a large additional inefficiency of response-adaptive randomization, regardless of whether a time trend actually exists.
    MeSH term(s) Bias ; Humans ; Random Allocation ; Research Design ; Sample Size
    Language English
    Publishing date 2022-01-06
    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 10.1177/17407745211065762
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  3. Article ; Online: Augmenting randomized clinical trial data with historical control data: Precision medicine applications.

    Freidlin, Boris / Korn, Edward L

    Journal of the National Cancer Institute

    2022  Volume 115, Issue 1, Page(s) 14–20

    Abstract: As precision medicine becomes more precise, the sizes of the molecularly targeted subpopulations become increasingly smaller. This can make it challenging to conduct randomized clinical trials of the targeted therapies in a timely manner. To help with ... ...

    Abstract As precision medicine becomes more precise, the sizes of the molecularly targeted subpopulations become increasingly smaller. This can make it challenging to conduct randomized clinical trials of the targeted therapies in a timely manner. To help with this problem of a small patient subpopulation, a study design that is frequently proposed is to conduct a small randomized clinical trial (RCT) with the intent of augmenting the RCT control arm data with historical data from a set of patients who have received the control treatment outside the RCT (historical control data). In particular, strategies have been developed that compare the treatment outcomes across the cohorts of patients treated with the standard (control) treatment to guide the use of the historical data in the analysis; this can lessen the potential well-known biases of using historical controls without any randomization. Using some simple examples and completed studies, we demonstrate in this commentary that these strategies are unlikely to be useful in precision medicine applications.
    MeSH term(s) Humans ; Precision Medicine ; Research Design ; Treatment Outcome
    Language English
    Publishing date 2022-10-14
    Publishing country United States
    Document type Randomized Controlled Trial ; Journal Article
    ZDB-ID 2992-0
    ISSN 1460-2105 ; 0027-8874 ; 0198-0157
    ISSN (online) 1460-2105
    ISSN 0027-8874 ; 0198-0157
    DOI 10.1093/jnci/djac185
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  4. Article ; Online: Timing and Reporting of Secondary Overall Survival End Points for Phase III Trials in Advanced/Metastatic Disease.

    Freidlin, Boris / Korde, Larissa A / Korn, Edward L

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

    2023  Volume 41, Issue 29, Page(s) 4616–4620

    Abstract: Recent therapeutic advances have led to improved patient survival in many cancer settings. Although prolongation of survival remains the ultimate goal of cancer treatment, the availability of effective salvage therapies could make definitive phase III ... ...

    Abstract Recent therapeutic advances have led to improved patient survival in many cancer settings. Although prolongation of survival remains the ultimate goal of cancer treatment, the availability of effective salvage therapies could make definitive phase III trials with primary overall survival (OS) end points difficult to complete in a timely manner. Therefore, to accelerate development of new therapies, many phase III trials of new cancer therapies are now designed with intermediate primary end points (eg, progression-free survival in the metastatic setting) with OS designated as a secondary end point. We review recently published phase III trials and assess contemporary practices for designing and reporting OS as a secondary end point. We then provide design and reporting recommendations for trials with OS as a secondary end point to safeguard OS data integrity and optimize access to the OS data for patient, clinician, and public-health stakeholders.
    Language English
    Publishing date 2023-07-20
    Publishing country United States
    Document type Journal Article
    ZDB-ID 604914-x
    ISSN 1527-7755 ; 0732-183X
    ISSN (online) 1527-7755
    ISSN 0732-183X
    DOI 10.1200/JCO.23.00413
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  5. Article ; Online: A Problematic Biomarker Trial Design.

    Freidlin, Boris / Korn, Edward L

    Journal of the National Cancer Institute

    2021  Volume 114, Issue 2, Page(s) 187–190

    Abstract: Efficient biomarker-driven randomized clinical trials are a key tool for implementing precision oncology. A commonly used biomarker phase III design is focused on testing the treatment effect in biomarker-positive and overall study populations. This ... ...

    Abstract Efficient biomarker-driven randomized clinical trials are a key tool for implementing precision oncology. A commonly used biomarker phase III design is focused on testing the treatment effect in biomarker-positive and overall study populations. This approach may result in recommending new treatments to biomarker-negative patients when these treatments have no benefit for these patients.
    MeSH term(s) Biomarkers ; Humans ; Medical Oncology ; Neoplasms/drug therapy ; Neoplasms/therapy ; Precision Medicine ; Randomized Controlled Trials as Topic ; Research Design
    Chemical Substances Biomarkers
    Language English
    Publishing date 2021-07-01
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2992-0
    ISSN 1460-2105 ; 0027-8874 ; 0198-0157
    ISSN (online) 1460-2105
    ISSN 0027-8874 ; 0198-0157
    DOI 10.1093/jnci/djab144
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  6. Article ; Online: The potential to backfill in phase I trials: the National Cancer Institute's Cancer Therapy Evaluation Program experience.

    Foster, Jared C / Korn, Edward L / Freidlin, Boris / Moscow, Jeffrey A

    JNCI cancer spectrum

    2023  Volume 7, Issue 6

    MeSH term(s) United States ; Humans ; National Cancer Institute (U.S.) ; Research Design ; Neoplasms/therapy
    Language English
    Publishing date 2023-11-23
    Publishing country England
    Document type Clinical Trial, Phase I ; Journal Article
    ISSN 2515-5091
    ISSN (online) 2515-5091
    DOI 10.1093/jncics/pkad102
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  7. Article ; Online: Improving precision oncology through better designs and reporting of biomarker-driven randomized clinical trials.

    LoRusso, Patricia M / Freidlin, Boris

    Journal of the National Cancer Institute

    2022  Volume 115, Issue 2, Page(s) 122–124

    MeSH term(s) Humans ; Neoplasms ; Precision Medicine ; Randomized Controlled Trials as Topic ; Medical Oncology ; Biomarkers ; Research Design
    Chemical Substances Biomarkers
    Language English
    Publishing date 2022-11-30
    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/djac212
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  8. Article ; Online: Reply to H. Uno et al and B. Huang et al.

    Freidlin, Boris / Korn, Edward L

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

    2020  Volume 38, Issue 17, Page(s) 2003–2004

    Language English
    Publishing date 2020-04-21
    Publishing country United States
    Document type Letter ; Comment
    ZDB-ID 604914-x
    ISSN 1527-7755 ; 0732-183X
    ISSN (online) 1527-7755
    ISSN 0732-183X
    DOI 10.1200/JCO.20.00015
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  9. Article ; Online: Backfilling Patients in Phase I Dose-Escalation Trials Using Bayesian Optimal Interval Design (BOIN).

    Zhao, Yixuan / Yuan, Ying / Korn, Edward L / Freidlin, Boris

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

    2023  Volume 30, Issue 4, Page(s) 673–679

    Abstract: In recent years, there has been increased interest in incorporation of backfilling into dose-escalation clinical trials, which involves concurrently assigning patients to doses that have been previously cleared for safety by the dose-escalation design. ... ...

    Abstract In recent years, there has been increased interest in incorporation of backfilling into dose-escalation clinical trials, which involves concurrently assigning patients to doses that have been previously cleared for safety by the dose-escalation design. Backfilling generates additional information on safety, tolerability, and preliminary activity on a range of doses below the maximum tolerated dose (MTD), which is relevant for selection of the recommended phase II dose and dose optimization. However, in practice, backfilling may not be rigorously defined in trial protocols and implemented consistently. Furthermore, backfilling designs require careful planning to minimize the probability of treating additional patients with potentially inactive agents (and/or subtherapeutic doses). In this paper, we propose a simple and principled approach to incorporate backfilling into the Bayesian optimal interval design (BOIN). The design integrates data from the dose-escalation and backfilling components of the design and ensures that the additional patients are treated at doses where some activity has been seen. Simulation studies demonstrated that the proposed backfilling BOIN design (BF-BOIN) generates additional data for future dose optimization, maintains the accuracy of the MTD identification, and improves patient safety without prolonging the trial duration.
    MeSH term(s) Humans ; Bayes Theorem ; Computer Simulation ; Maximum Tolerated Dose ; Research Design ; Dose-Response Relationship, Drug ; Neoplasms/drug therapy
    Language English
    Publishing date 2023-12-04
    Publishing country United States
    Document type Clinical Trial, Phase I ; Journal Article
    ZDB-ID 1225457-5
    ISSN 1557-3265 ; 1078-0432
    ISSN (online) 1557-3265
    ISSN 1078-0432
    DOI 10.1158/1078-0432.CCR-23-2585
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  10. Article ; Online: Clinical Benefit Scales and Trial Design: Some Statistical Issues.

    Korn, Edward L / Allegra, Carmen J / Freidlin, Boris

    Journal of the National Cancer Institute

    2022  Volume 114, Issue 9, Page(s) 1222–1227

    Abstract: Recently developed clinical-benefit outcome scales by the European Society for Medical Oncology and the American Society of Clinical Oncology allow standardized objective evaluation of outcomes of randomized clinical trials. However, incorporation of ... ...

    Abstract Recently developed clinical-benefit outcome scales by the European Society for Medical Oncology and the American Society of Clinical Oncology allow standardized objective evaluation of outcomes of randomized clinical trials. However, incorporation of clinical-benefit outcome scales into trial designs highlights a number of statistical issues: the relationship between minimal clinical benefit and the target treatment-effect alternative used in the trial design, designing trials to assess long-term benefit, potential problems with using a trial endpoint that is not overall survival, and how to incorporate subgroup analyses into the trial design. Using the European Society for Medical Oncology Magnitude of Clinical Benefit Scale as a basis for discussion, we review what these issues are and how they can guide the choice of trial-design target effects, appropriate endpoints, and prespecified subgroup analyses to increase the chances that the resulting trial outcomes can be appropriately evaluated for clinical benefit.
    MeSH term(s) Humans ; Medical Oncology/methods ; Neoplasms/drug therapy
    Language English
    Publishing date 2022-05-18
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 2992-0
    ISSN 1460-2105 ; 0027-8874 ; 0198-0157
    ISSN (online) 1460-2105
    ISSN 0027-8874 ; 0198-0157
    DOI 10.1093/jnci/djac099
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