Development of a translational medicine protocol for an NCTN genitourinary clinical trial

Critical steps, common pitfalls and a basic guide to translational clinical research

Joshua J Meeks*, Amir Goldkorn, Ana M. Aparicio, David J. McConkey

*Corresponding author for this work

Research output: Contribution to journalReview article

Abstract

Translational medicine (TM) components of prospective clinical trials provide an invaluable opportunity to test hypotheses that contribute to our knowledge of human disease biology and/or the mechanism of action of a given therapeutic intervention. Our ability to sample tumors and their microenvironment, and the depth and breadth of biological information that can be extracted from them, has increased exponentially in recent years. This information is critical to guide the next steps clinical research if we are to accelerate the pace of progress in cancer treatment. Thus, TM studies should be considered key components of any clinical trial. However, TM studies are costly and biologic sampling can impose significant morbidity on our patients. Therefore, TM investigators should be engaged early in the design process (similar to a statistician) to ensure that the most imperative research questions are rigourosly defined, that the obtained specimens can be used to answer them and that the results will serve as the foundation for additional studies. In this review, we focus on TM studies in the context of the National Cancer Institute's National Clinical Trials Network trials and offer a description of the genesis of TM components, methods in sample acquisition and biomarker research, and a guide to funding mechanisms, in order to provide a blueprint for future TM research protocols. While TM studies can take many forms, the research discussed primarily focusses on basic and translational research involving molecular, cellular, and immunobiology.

Original languageEnglish (US)
Pages (from-to)313-317
Number of pages5
JournalUrologic Oncology: Seminars and Original Investigations
Volume37
Issue number5
DOIs
StatePublished - May 1 2019

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Translational Medical Research
Clinical Trials
Research
Tumor Microenvironment
National Cancer Institute (U.S.)
Biomarkers
Research Personnel
Morbidity

Keywords

  • Translational medicine

ASJC Scopus subject areas

  • Oncology
  • Urology

Cite this

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abstract = "Translational medicine (TM) components of prospective clinical trials provide an invaluable opportunity to test hypotheses that contribute to our knowledge of human disease biology and/or the mechanism of action of a given therapeutic intervention. Our ability to sample tumors and their microenvironment, and the depth and breadth of biological information that can be extracted from them, has increased exponentially in recent years. This information is critical to guide the next steps clinical research if we are to accelerate the pace of progress in cancer treatment. Thus, TM studies should be considered key components of any clinical trial. However, TM studies are costly and biologic sampling can impose significant morbidity on our patients. Therefore, TM investigators should be engaged early in the design process (similar to a statistician) to ensure that the most imperative research questions are rigourosly defined, that the obtained specimens can be used to answer them and that the results will serve as the foundation for additional studies. In this review, we focus on TM studies in the context of the National Cancer Institute's National Clinical Trials Network trials and offer a description of the genesis of TM components, methods in sample acquisition and biomarker research, and a guide to funding mechanisms, in order to provide a blueprint for future TM research protocols. While TM studies can take many forms, the research discussed primarily focusses on basic and translational research involving molecular, cellular, and immunobiology.",
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