Skip to main content

Comparative effectiveness research, genomics-enabled personalized medicine, and rapid learning health care: a common bond.

Publication ,  Journal Article
Ginsburg, GS; Kuderer, NM
Published in: J Clin Oncol
December 1, 2012

Despite stunning advances in our understanding of the genetics and the molecular basis for cancer, many patients with cancer are not yet receiving therapy tailored specifically to their tumor biology. The translation of these advances into clinical practice has been hindered, in part, by the lack of evidence for biomarkers supporting the personalized medicine approach. Most stakeholders agree that the translation of biomarkers into clinical care requires evidence of clinical utility. The highest level of evidence comes from randomized controlled clinical trials (RCTs). However, in many instances, there may be no RCTs that are feasible for assessing the clinical utility of potentially valuable genomic biomarkers. In the absence of RCTs, evidence generation will require well-designed cohort studies for comparative effectiveness research (CER) that link detailed clinical information to tumor biology and genomic data. CER also uses systematic reviews, evidence-quality appraisal, and health outcomes research to provide a methodologic framework for assessing biologic patient subgroups. Rapid learning health care (RLHC) is a model in which diverse data are made available, ideally in a robust and real-time fashion, potentially facilitating CER and personalized medicine. Nonetheless, to realize the full potential of personalized care using RLHC requires advances in CER and biostatistics methodology and the development of interoperable informatics systems, which has been recognized by the National Cancer Institute's program for CER and personalized medicine. The integration of CER methodology and genomics linked to RLHC should enhance, expedite, and expand the evidence generation required for fully realizing personalized cancer care.

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

December 1, 2012

Volume

30

Issue

34

Start / End Page

4233 / 4242

Location

United States

Related Subject Headings

  • Precision Medicine
  • Oncology & Carcinogenesis
  • Neoplasms
  • Humans
  • Genomics
  • Decision Making
  • Comparative Effectiveness Research
  • 3211 Oncology and carcinogenesis
  • 1112 Oncology and Carcinogenesis
  • 1103 Clinical Sciences
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Ginsburg, G. S., & Kuderer, N. M. (2012). Comparative effectiveness research, genomics-enabled personalized medicine, and rapid learning health care: a common bond. J Clin Oncol, 30(34), 4233–4242. https://doi.org/10.1200/JCO.2012.42.6114
Ginsburg, Geoffrey S., and Nicole M. Kuderer. “Comparative effectiveness research, genomics-enabled personalized medicine, and rapid learning health care: a common bond.J Clin Oncol 30, no. 34 (December 1, 2012): 4233–42. https://doi.org/10.1200/JCO.2012.42.6114.
Ginsburg, Geoffrey S., and Nicole M. Kuderer. “Comparative effectiveness research, genomics-enabled personalized medicine, and rapid learning health care: a common bond.J Clin Oncol, vol. 30, no. 34, Dec. 2012, pp. 4233–42. Pubmed, doi:10.1200/JCO.2012.42.6114.

Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

December 1, 2012

Volume

30

Issue

34

Start / End Page

4233 / 4242

Location

United States

Related Subject Headings

  • Precision Medicine
  • Oncology & Carcinogenesis
  • Neoplasms
  • Humans
  • Genomics
  • Decision Making
  • Comparative Effectiveness Research
  • 3211 Oncology and carcinogenesis
  • 1112 Oncology and Carcinogenesis
  • 1103 Clinical Sciences