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Advances in Clinical Trials: Outcome, Innovations, Challenges, and Ethical Practice...
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Advances in Clinical Trials: Outcome, Innovations, Challenges, and Ethical Practice in Cancer Research 2024–2025

A special issue of Cancers (ISSN 2072-6694). This special issue belongs to the section "Clinical Research of Cancer".

Deadline for manuscript submissions: 31 December 2025 | Viewed by 3295

Special Issue Editors

Prof. Dr. Naoto T. Ueno

E-Mail Website
Guest Editor
Translational and Clinical Research Program, University of Hawai’i Cancer Center, Honolulu, HI 96813, USA
Interests: triple-negative breast cancer; inflammatory breast cancer; bone metastasis; metastatic breast cancer; early drug development
Special Issues, Collections and Topics in MDPI journals
Prof. Dr. David R. Gandara

E-Mail Website
Guest Editor
1. Co-Director, Center for Experimental Therapeutics in Cancer, University of California Davis Comprehensive Cancer Center, Sacramento, CA 95817, USA
2. Adjunct Clinical Professor, Translational and Clinical Research Program, University of Hawaii Cancer Center, Honolulu, HI 96813, USA
Interests: predictive biomarkers; cancer drug development; team science; population-related pharmaco-genomics; tumor mutational burden

Special Issue Information

Dear Colleagues,

Welcome to this Special Issue. We are at the forefront of an era that greatly values the dissemination of clinical trial outcomes of all phase studies (phase I, phase II, phase III, and phase IV), recognizing the profound impact of shared knowledge on the advancement of medical science. In this spirit, we encourage you to publish your findings, understanding that each piece of data, whether from trials that have met their endpoints or those that have not, propels us closer to scientific breakthroughs.

This Special Issue is committed to unraveling clinical trials' complexities and dynamic nature. Our objective is to thoroughly analyze their contemporary features, their design and implementation, and how they contribute to the forward momentum of medical research. We seek contributions in the form of original research, editorial insights, and comprehensive reviews that highlight innovative clinical trial outcomes.

We will spotlight pioneering methodologies that set new precedents in clinical research, including adaptive designs, patient-centered strategies, and the seamless incorporation of technology into trial management. Our readers will gain an intricate understanding of these methods in practice, the guiding regulatory frameworks, and the ethical pillars at their heart.

Moreover, we advocate for sharing all cancer clinical trial results openly. Regardless of their nature, each result significantly enriches our collective wisdom and influences the future path of scientific inquiry.

We invite you to share your experiences of success and the challenges faced during the execution of modern clinical trials. Your insights are invaluable in shaping the future of clinical research. Together, we strive to create a collaborative platform that fosters the development of treatments with a meaningful impact on our cancer community.

Mahalo for your unwavering commitment to advancing our understanding of this critical aspect of cancer clinical trials.

Prof. Dr. Naoto T. Ueno
Prof. Dr. David R. Gandara
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Cancers is an international peer-reviewed open access semimonthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2900 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • phase I
  • phase II
  • phase III
  • phase IV
  • clinical trials
  • features
  • design
  • implementation
  • outcomes

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Further information on MDPI's Special Issue policies can be found here.

Published Papers (3 papers)

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Research

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12 pages, 596 KiB  
Article
Design of a Phase I Drug Combination Study with Adaptive Allocation Based on Dose-Limiting Toxicity Attribution
by Nolan A. Wages, Bethany J. Horton, Li Liu, Enrica Marchi and Gina R. Petroni
Cancers 2025, 17(6), 1038; https://doi.org/10.3390/cancers17061038 - 20 Mar 2025
Cited by 1 | Viewed by 484
Abstract
Background: This article describes the adaptation of a Phase I drug combination method to incorporate dose-limiting toxicity (DLT) attribution in dose assignments. The study is motivated by the Embolden trial (NCT03240211), a Phase Ib, multicenter trial at the UVA Comprehensive Cancer Center evaluating [...] Read more.
Background: This article describes the adaptation of a Phase I drug combination method to incorporate dose-limiting toxicity (DLT) attribution in dose assignments. The study is motivated by the Embolden trial (NCT03240211), a Phase Ib, multicenter trial at the UVA Comprehensive Cancer Center evaluating pembrolizumab with pralatrexate (Arm A), decitabine (Arm C), or both (Arm B) in relapsed/refractory peripheral and cutaneous T cell lymphomas. Methods: While Arms A and C used monotherapy dose escalation, Arm B required simultaneous escalation of both agents, integrating drug-specific DLT attribution to guide dosing. Results: We adapted the partial order continual reassessment method (POCRM) to incorporate this attribution, ensuring appropriate de-escalation of the offending agent. Given the trial’s complexity, software modifications were necessary to evaluate design performance through simulations. Conclusions: This work underscores the importance of novel dose-finding strategies in early-phase trials and aims to promote their broader adoption for improved trial efficiency and transparency. Full article
(This article belongs to the Special Issue Advances in Clinical Trials: Outcome, Innovations, Challenges, and Ethical Practice in Cancer Research 2024–2025)
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Review

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12 pages, 1593 KiB  
Review
Next-Generation CAR-T and TCR-T Cell Therapies for Solid Tumors: Innovations, Challenges, and Global Development Trends
by Tomomi Sanomachi, Yuki Katsuya, Tetsuya Nakatsura and Takafumi Koyama
Cancers 2025, 17(12), 1945; https://doi.org/10.3390/cancers17121945 - 11 Jun 2025
Abstract
Chimeric antigen receptor (CAR)-T and T-cell receptor (TCR)-engineered T-cell (TCR-T) therapies have revolutionized the treatment of hematological malignancies; however, their application to solid tumors remains a formidable challenge. The immunosuppressive tumor microenvironment, antigen heterogeneity, and manufacturing complexity limit the clinical efficacy and scalability [...] Read more.
Chimeric antigen receptor (CAR)-T and T-cell receptor (TCR)-engineered T-cell (TCR-T) therapies have revolutionized the treatment of hematological malignancies; however, their application to solid tumors remains a formidable challenge. The immunosuppressive tumor microenvironment, antigen heterogeneity, and manufacturing complexity limit the clinical efficacy and scalability of these treatment modalities. This review provides a comprehensive analysis of the current clinical development strategies for CAR-T and TCR-T cell therapies for solid tumors. Herein, we discuss recent breakthroughs and highlight the potential of TCR-T cell therapy. Furthermore, innovative approaches for enhancing CAR-T cell function in solid tumors (e.g., in vivo engineering; induced pluripotent stem cell-derived allogeneic CAR-T cells; armored CAR constructs; dual-antigen targeting; and combination regimens with checkpoint inhibitors, chemotherapy, radiotherapy, and oncolytic viruses) are explored. We also present trends in global patent activity, revealing a marked acceleration in CAR-T- and TCR-T-related innovations, with the United States and China leading with respect to application volumes. This field is increasingly characterized by multidisciplinary collaborations between academia and industry, driving the development of next-generation platforms, including messenger RNA-based and off-the-shelf cell therapies. Although no CAR-T product has been approved for solid tumors, these findings underscore the accelerating momentum and translational promise of adoptive cell therapies. Addressing the unique biological and logistical challenges of solid tumors is essential for realizing the full potential of these transformative immunotherapies. Full article
(This article belongs to the Special Issue Advances in Clinical Trials: Outcome, Innovations, Challenges, and Ethical Practice in Cancer Research 2024–2025)
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20 pages, 617 KiB  
Review
Advancements in Electronic Medical Records for Clinical Trials: Enhancing Data Management and Research Efficiency
by Mingyu Lee, Kyuri Kim, Yoojin Shin, Yoonji Lee and Tae-Jung Kim
Cancers 2025, 17(9), 1552; https://doi.org/10.3390/cancers17091552 - 2 May 2025
Viewed by 629
Abstract
Recent advancements in electronic medical records (EMRs) have transformed clinical trials and healthcare systems by improving data accuracy, regulatory compliance, and integration with decision support tools. These innovations enhance trial efficiency, streamline patient recruitment, and enable large-scale data analysis while bridging clinical practice [...] Read more.
Recent advancements in electronic medical records (EMRs) have transformed clinical trials and healthcare systems by improving data accuracy, regulatory compliance, and integration with decision support tools. These innovations enhance trial efficiency, streamline patient recruitment, and enable large-scale data analysis while bridging clinical practice with research. Despite these benefits, challenges such as data standardization, privacy concerns, and usability issues persist. Overcoming these barriers through policy reforms, technological innovations, and robust methodologies is essential to maximizing the potential of EMRs. We examine current developments, challenges, and future directions for optimizing EMRs in clinical trials and healthcare delivery. Full article
(This article belongs to the Special Issue Advances in Clinical Trials: Outcome, Innovations, Challenges, and Ethical Practice in Cancer Research 2024–2025)
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