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Current Oncology
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Advancements in Clinical Trials in Oncology: Design, Enrichment, Safety, Operations,...
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Advancements in Clinical Trials in Oncology: Design, Enrichment, Safety, Operations, Patient Centricity, and Endpoints

A special issue of Current Oncology (ISSN 1718-7729).

Deadline for manuscript submissions: 31 December 2024 | Viewed by 4245

Special Issue Editor

Dr. Brandon Michael Henry

E-Mail Website
Guest Editor
Clinical Nephrology Laboratory, Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229, USA
Interests: cell and gene therapies; immunotherapies; clinical trial design; early-phase trials; drug safety

Special Issue Information

Dear Colleagues, 

I am pleased to announce a Special Issue in Current Oncology, titled "Advancements in Clinical Trials in Oncology: Design, Enrichment, Safety, Operations, Patient Centricity, and Endpoints", for which I am honored to serve as the Guest Editor. This issue seeks to explore the latest developments in early-phase and late-phase trial design, adaptive designs for targeted therapies, immunotherapies, and cell and gene therapy trials, and the integration of patient-centric elements in oncology clinical trials.

The landscape of oncology clinical trials has undergone remarkable transformations, witnessing rapid developments and breakthrough therapies receiving advanced approvals. As such, it is essential to highlight the novel approaches in trial design, ensuring safety, efficacy, and meaningful outcomes in this dynamic environment.

This Special Issue will delve into cutting-edge methodologies for early-phase trial design, focusing on adaptive designs that empower flexibility and efficiency while maintaining robust statistical rigor, as well as strategies to ensure the safety of trial patients. Emphasizing targeted therapies and biologics, we aim to discuss how adaptive designs can address the unique challenges posed by these groundbreaking therapeutic modalities.

Furthermore, we acknowledge the importance of patient centricity in clinical trials. We will explore innovative strategies to incorporate patient perspectives and preferences into trial design, fostering better communication, adherence, and overall trial experience for participants.

Finally, we also encourage submissions focusing on the critical aspects of biomarker enrichment and biomarker-based endpoints, as they play a pivotal role in tailoring oncology clinical trials and refining patient stratification strategies, ultimately enhancing the precision and effectiveness of novel therapies in the era of personalized medicine.

Together, let us explore the forefront of trial design, safety, operations, patient centricity, and statistics to advance cancer care, improve patient outcomes, and foster interdisciplinary discussions that will contribute to shaping the future of clinical trials in oncology.

Dr. Brandon Michael Henry
Guest Editor

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 short 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. Current Oncology is an international peer-reviewed open access monthly 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 2200 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

  • oncology clinical trials
  • drug safety
  • endpoints
  • biomarkers
  • study design
  • methodology
  • biologics
  • targeted therapies

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

Published Papers (3 papers)

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Research

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14 pages, 1208 KiB  
Article
Challenges and Opportunities in Developing an Oncology Clinical Trial Network in the United States Veterans Affairs Health Care System: The VA STARPORT Experience
by Abhishek A. Solanki, Kevin Zheng, Alicia N. Skipworth, Lisa M. Robin, Ryan F. Leparski, Elizabeth Henry, Matthew Rettig, Joseph K. Salama, Timothy Ritter, Jeffrey Jones, Marcus Quek, Michael Chang, Alec M. Block, James S. Welsh, Aryavarta Kumar, Hann-Hsiang Chao, Albert C. Chen, Ronald Shapiro, Rhonda L. Bitting, Robert Kwon, William Stross, Lindsay Puckett, Yu-Ning Wong, Nicholas G. Nickols and Kimberly Carlsonadd Show full author list remove Hide full author list
Curr. Oncol. 2024, 31(8), 4781-4794; https://doi.org/10.3390/curroncol31080358 - 21 Aug 2024
Viewed by 1151
Abstract
The United States Veterans Affairs (VA) Health Care System has a strong history of conducting impactful oncology randomized clinical trials (RCTs). We developed a phase II/III RCT to test the use of metastasis-directed therapy in Veterans with oligometastatic prostate cancer (OMPC)—the first VA [...] Read more.
The United States Veterans Affairs (VA) Health Care System has a strong history of conducting impactful oncology randomized clinical trials (RCTs). We developed a phase II/III RCT to test the use of metastasis-directed therapy in Veterans with oligometastatic prostate cancer (OMPC)—the first VA RCT in OMPC that leverages novel imaging and advanced radiotherapy techniques. To accomplish this, we developed a clinical trial network to conduct the study. In this manuscript, we describe several challenges we encountered in study development/conduct and our strategies to address them, with the goal of helping investigators establish robust study networks to conduct clinical trials. In the study start-up, we encountered challenges in timely site activation, and leveraged project management to maximize efficiency. Additionally, there were several changes in the clinical paradigms in imaging and treatment that led to protocol amendments to ensure maximum equipoise, recruitment, and impact of the study. Specifically, we amended the trial to add de novo OMPC patients (from initially only recurrent OMPC) and expanded the study to allow up to 10 metastases (from initially five). Finally, in order to maintain local study team engagement, we developed initiatives to maximize collaboration and add value to the overall clinical program through study participation. Full article
(This article belongs to the Special Issue Advancements in Clinical Trials in Oncology: Design, Enrichment, Safety, Operations, Patient Centricity, and Endpoints)
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7 pages, 215 KiB  
Article
Pharmacy Workload in Clinical Trial Management: A Preliminary Complexity Assessment Tool for Sponsored Oncology and Haematology Trials
by Lorenzo Gasperoni, Carla Masini, Giada Toscano, Alessandro Cafaro, Chiara Zani, Cristina Andrianò, Paolo Silimbani, Caterina Donati, Giorgia Bortolin and Sara Cecco
Curr. Oncol. 2024, 31(5), 2867-2873; https://doi.org/10.3390/curroncol31050218 - 16 May 2024
Viewed by 1365
Abstract
Investigational drug services need to be organised in a structured approach, especially for sites with a large number of ongoing clinical trials. The aim of this study was to develop a tool to assess the complexity of pharmacy involvement in a sponsored oncology [...] Read more.
Investigational drug services need to be organised in a structured approach, especially for sites with a large number of ongoing clinical trials. The aim of this study was to develop a tool to assess the complexity of pharmacy involvement in a sponsored oncology clinical trial. Categorisation into ordinal complexity categories was used to assess the complexity of the clinical trials for consistent pharmacy grant applications. The 15 items of the tool were divided into three sections, and individual item scores were agreed upon among four pharmacists with experience in the conduct of clinical trials at two different centres. A final version of the tool, named Pharm-CAT, was approved. The pharmacists were instructed to use Pharm-CAT to assign a score to each new sponsored trial. To determine the cut-offs for the complexity categories, the scores were sorted in ascending order and the cut-offs corresponding to the first and third tertiles of the score distribution were selected. To verify the reproducibility of the results, Pharm-CAT was applied by two pharmacists independently for each trial. Pharm-CAT proved to be user-friendly. Sixty clinical trials were evaluated and a total of 120 scores were recorded. Low-complexity scores ranged from 0 to 19, medium-complexity scores ranged from 20 to 25, and high-complexity scores were 26 or higher. The average score recorded was 22.88 points. Prospective multicentre validation of Pharm-CAT is needed to confirm its applicability. Full article
(This article belongs to the Special Issue Advancements in Clinical Trials in Oncology: Design, Enrichment, Safety, Operations, Patient Centricity, and Endpoints)

Review

Jump to: Research

14 pages, 286 KiB  
Review
What Is Ailing Oncology Clinical Trials? Can We Fix Them?
by Abhenil Mittal, Sara Moore, Vishal Navani, Di Maria Jiang, David J. Stewart, Geoffrey Liu and Paul Wheatley-Price
Curr. Oncol. 2024, 31(7), 3738-3751; https://doi.org/10.3390/curroncol31070275 - 28 Jun 2024
Viewed by 950
Abstract
Evidence from phase three clinical trials helps shape clinical practice. However, a very small minority of patients with cancer participate in clinical trials and many trials are not completed on time due to slow accrual. Issues with restrictive eligibility criteria can severely limit [...] Read more.
Evidence from phase three clinical trials helps shape clinical practice. However, a very small minority of patients with cancer participate in clinical trials and many trials are not completed on time due to slow accrual. Issues with restrictive eligibility criteria can severely limit the patients who can access trials, without any convincing evidence that these restrictions impact patient safety. Similarly, regulatory, organizational, and institutional hurdles can delay trial activation, ultimately making some studies irrelevant. Additional issues during trial conduct (e.g., mandatory in-person visits, central confirmation of standard biomarkers, and inflexible drug dosage modification) contribute to making trials non-patient-centric. These real-life observations from experienced clinical trialists can seem nonsensical to investigators and patients alike, who are trying to bring effective drugs to patients with cancer. In this review, we delve into these issues in detail, and discuss potential solutions to make clinical trials more accessible to patients. Full article
(This article belongs to the Special Issue Advancements in Clinical Trials in Oncology: Design, Enrichment, Safety, Operations, Patient Centricity, and Endpoints)
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