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 958

Special Issue Editor


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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

Published Papers (1 paper)

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Research

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 535
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
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