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Correlative Studies in Clinical Trials: A Position Statement From the International Thyroid Oncology Group
Keith C Bible1, Gilbert J Cote1, Michael J Demeure1
1Mayo Clinic (K.C.B.), Rochester, Minnesota, Minnesota 55905; MD Anderson Cancer Center (G.J.C.), Houston, Texas 77030; Translational Genomics Research Institute (M.J.D.), Phoenix, Arizona 85004; University of Pisa (R.E.), 56126 Pisa, Italy; and The Ohio State University and Arthur G. James Comprehensive Cancer Center (S.J., M.D.R.), Columbus Ohio 43210.
Objective:
Patients with progressive thyroid cancer in distant metastatic sites represent a population with a need for new therapeutic options. Aspiring to improve the treatment of such patients, the objective of this position statement from the International Thyroid Oncology Group (ITOG) is to clarify the importance of incorporating high-quality correlative studies into clinical trials.
Participants:
ITOG was formed to develop and support high-quality multicenter and multidisciplinary clinical trials for patients with aggressive forms of thyroid cancer. The Correlative Sciences Committee of the ITOG focuses on the quality and types of correlative studies included in ITOG-associated clinical trials.
Evidence:
This document represents expert consensus from ITOG regarding this issue based on extensive collective experience in clinical and translational trials informed by basic science.
Consensus Process:
The Correlative Studies Committee identified an international writing group representative of diverse specialties, including basic sciences. Drafts were reviewed by all members of the writing group, the larger committee, and the ITOG board. After consideration of all comments by the writing group and modification of the document, the final document was then approved by the authors and the ITOG board.
Conclusions:
High-quality correlative studies, which include variety in the types of correlates, should be intrinsic to the design of thyroid cancer clinical trials to offer the best opportunity for each study to advance treatment for patients with advanced and progressive thyroid cancer.