TY - JOUR
T1 - Development of a translational medicine protocol for an NCTN genitourinary clinical trial
T2 - Critical steps, common pitfalls and a basic guide to translational clinical research
AU - Meeks, Joshua J.
AU - Goldkorn, Amir
AU - Aparicio, Ana M.
AU - McConkey, David J.
N1 - Publisher Copyright:
© 2018 Elsevier Inc.
PY - 2019/5
Y1 - 2019/5
N2 - 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.
AB - 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.
KW - Translational medicine
UR - http://www.scopus.com/inward/record.url?scp=85051379181&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85051379181&partnerID=8YFLogxK
U2 - 10.1016/j.urolonc.2018.06.008
DO - 10.1016/j.urolonc.2018.06.008
M3 - Review article
C2 - 30115512
AN - SCOPUS:85051379181
SN - 1078-1439
VL - 37
SP - 313
EP - 317
JO - Urologic Oncology: Seminars and Original Investigations
JF - Urologic Oncology: Seminars and Original Investigations
IS - 5
ER -