Innovative Trial Designs and Biomarkers in Vulnerable Cancer Populations Research

The underrepresentation of the majority of cancer patients in clinical trials represents a crucial drawback and participants in clinical trials are often not representative of the target populations. The generalisability of the translation of trial results is usually hampered by the strict inclusion criteria of clinical trials, while extrapolation of clinical trial results to a real-world population risks exposing many patients to strategies that have never been proven to be safe and effective in their subpopulations. Innovative trial design is an emerging approach that integrates several techniques to address the respective challenges. In addition, more extensive use of innovative biomarkers may offer new opportunities in cancer management, especially for patients who are considered vulnerable and require the appropriate and often more specialized care. Further, the challenges posed by vulnerable patient populations can contribute to the much-needed transformation of contemporary personalized cancer care.

This Special Issue welcomes contributions that improve our understanding of all aspects of clinical trial design and biomarker research in vulnerable cancer patient populations. From research on prevention to palliative care research, from phase I to phase IV trials, vulnerable patients are underrepresented everywhere as such we are particularly interested in research on vulnerable patient populations and studies that use new methodologies to examine these groups. Research reports using methodologies of new trial design and biomarker research in these vulnerable populations are strongly encouraged. Papers dealing with cost-utility analyses or health economic assessments focusing on one or more vulnerable populations including biomarker aspects are also welcomed.

Potential areas of interest may include, but are not limited to:
● Biomarker research
● New or innovative trial designs
● Biomarker-based trial design
● Vulnerable populations such as, but not limited to, older patients, children, adolescents and young adults, pregnant patients, ethnic minorities, cognitively impaired patients, obese patients, psychiatric comorbidities, organ dysfunction sufferers, …
● Identification of vulnerable patients using functional scales, assessments (such as CGA) and/or biomarkers

We would like to acknowledge Dr Laura Tack and Freya Meganck who have acted as coordinators and have contributed to the preparation of the proposal for this article collection.

Even though abstract submission is not mandatory, we encourage all interested researchers to submit an abstract before submitting their manuscript. Abstracts do not have to coincide with the final abstract of the manuscripts. For authors, please review the journal's information regarding Author Guidelines and Article Processing Charges, or direct any questions to the Editorial Office: por@por-journal.com.

Article types and fees

This Special Issue accepts the following article types, unless otherwise specified in the Special Issue description:

• Brief Research Report
• Case Report
• Commentary
• Guideline
• Hypothesis & Theory
• Letter to the Editor
• Mini Review
• Original Research
• Review
• ... View all formats

Articles that are accepted for publication by our external editors following rigorous peer review incur a publishing fee charged to Authors, institutions, or funders.

Article types

This Special Issue accepts the following article types, unless otherwise specified in the Special Issue description:

• Brief Research Report
• Case Report
• Commentary
• Guideline
• Hypothesis & Theory
• Letter to the Editor
• Mini Review
• Original Research
• Review
• Study Protocol
• Systematic Review

Keywords: Biomarkers, Innovative trial design, Vulnerable populations, Trial inclusion, Identification of vulnerable patients