TY - JOUR
T1 - Why and How Should We Integrate Biomarkers into Complex Trials? A Discussion on Paradigms and Clinical Research Strategies
AU - Musial, Frauke
AU - Mist, Scott
AU - Warber, Sara
AU - Kreitzer, Mary Jo
AU - Ritenbaugh, Cheryl
AU - Kessler, Christian
N1 - Funding Information:
The Northern Lights Workshop in Sommarøy, 2012, was supported by a grant from the faculty of health sciences, UiT, The Arctic University of Norway, Tromsø, Norway. We are thankful to Åsa Sohlen for indispensable technical support.
Publisher Copyright:
© 2019 S. Karger AG, Basel.
PY - 2019/10/1
Y1 - 2019/10/1
N2 - Background: Research in complementary and alternative medicine (CAM) encounters a variety of challenges, such as potentially synergistic, multimodal, and complex interventions which are often dependent on the relationship between practitioner and patient, on specific settings, and on patients' individual preferences, expectations, beliefs, and motivations. Moreover, patients seeking CAM care often suffer from chronic disease conditions, and multiple symptoms and/or pathologies. On the other hand, CAM interventions are often challenged as being solely dependent on subjective and nonspecific factors without biologically based mechanisms of action. If we agree that biomarkers as outcomes are important for the understanding of CAM interventions, a hypothesis- and strategy-driven process for the selection of the most appropriate biomarkers is needed. Methods: This paper presents the results of an expert panel on how to integrate biomarkers in whole system research of an interdisciplinary workshop on research methodology in CAM held in November 2012. Results: The following main CAM research challenges were identified: (a) finding appropriate biomarkers, which are able to picture the complex pathophysiological pathways and likewise complex interventions under study; (b) integrating these biomarkers into clinical trials in CAM; and (c) identifying the biomarkers specific to the particular CAM intervention being applied. Conclusion: The paper provides a disease/condition/symptom- and intervention-driven strategy regarding how to identify the outcomes of interest and possible related biomarkers. The research approach presented here allows the selected biomarkers to be grounded in conventional physiology/pathophysiology as well as complementary and alternative concepts, including traditional systems of medicine. The goal is to provide researchers in the field with a framework on how to integrate biomarkers into complex trials.
AB - Background: Research in complementary and alternative medicine (CAM) encounters a variety of challenges, such as potentially synergistic, multimodal, and complex interventions which are often dependent on the relationship between practitioner and patient, on specific settings, and on patients' individual preferences, expectations, beliefs, and motivations. Moreover, patients seeking CAM care often suffer from chronic disease conditions, and multiple symptoms and/or pathologies. On the other hand, CAM interventions are often challenged as being solely dependent on subjective and nonspecific factors without biologically based mechanisms of action. If we agree that biomarkers as outcomes are important for the understanding of CAM interventions, a hypothesis- and strategy-driven process for the selection of the most appropriate biomarkers is needed. Methods: This paper presents the results of an expert panel on how to integrate biomarkers in whole system research of an interdisciplinary workshop on research methodology in CAM held in November 2012. Results: The following main CAM research challenges were identified: (a) finding appropriate biomarkers, which are able to picture the complex pathophysiological pathways and likewise complex interventions under study; (b) integrating these biomarkers into clinical trials in CAM; and (c) identifying the biomarkers specific to the particular CAM intervention being applied. Conclusion: The paper provides a disease/condition/symptom- and intervention-driven strategy regarding how to identify the outcomes of interest and possible related biomarkers. The research approach presented here allows the selected biomarkers to be grounded in conventional physiology/pathophysiology as well as complementary and alternative concepts, including traditional systems of medicine. The goal is to provide researchers in the field with a framework on how to integrate biomarkers into complex trials.
KW - Biomarkers
KW - Complementary and alternative medicine
KW - Complex interventions
KW - Integrative medicine
KW - Traditional medicine
KW - Trial methodology
KW - Whole medical systems
UR - http://www.scopus.com/inward/record.url?scp=85064352321&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85064352321&partnerID=8YFLogxK
U2 - 10.1159/000498981
DO - 10.1159/000498981
M3 - Review article
C2 - 30974436
AN - SCOPUS:85064352321
SN - 2504-2092
VL - 26
SP - 343
EP - 352
JO - Complementary Medicine Research
JF - Complementary Medicine Research
IS - 5
ER -