IOM Committee Recommends Oversight, Common Evidentiary Standards for Biomarker Tests for Molecularly-targeted Therapies

Cancer Therapy Advisor


References

1. (open access) Committee on Policy Issues in the Clinical Development and Use of Biomarkers for Molecularly Targeted Therapies; Board on Health Care Services; Institute of Medicine; The National Academies of Sciences, Engineering, and Medicine. Graig LA, Phillips JK, Moses HL, eds. Biomarker tests for molecularly targeted therapies: key to unlocking precision medicine. Washington (DC): National Academies Press (US); 2016. 

 PREPUBLICATION DRAFT (229 pages)

This title is currently only available in Bookshelf as a prepublication draft version in PDF format (9.2M). The final version is forthcoming.

2. Mapes D. This is the future of oncology. Fred Hutch News Service. http://www.fredhutch.org/en/news/center-news/2016/03/precision-medicine-report-lays-plans-for-improved-patient-care.html. Published March 4, 2016. Accessed March 17, 2016.

 Research is beginning to assess adherence rates, and the impact
on survival and quality of life associated with adherence to certain guidelines in clinical conditions such as breast (Cloud et al., 2015; Henry et al., 2014) and ovarian cancers (Lee et al., 2015). However, while inclusion in a CPG may suggest a biomarker test and corresponding
targeted therapy have clinical utility when used together, formal assessment of clinical utility is beyond the scope of CPG development.