[Skip to Navigation]
Sign In
Comment & Response
July 8, 2021

Reporting the Analytical Method Is Essential to Assessing Studies in Which Biomarkers Are a Major Study Objective

Author Affiliations
  • 1Department of Laboratory Medicine, Netherlands Cancer Institute, Amsterdam, the Netherlands
  • 2Endocrine Laboratory, Department of Clinical Chemistry, Amsterdam UMC, Vrije Universiteit Amsterdam and University of Amsterdam, Amsterdam, the Netherlands
JAMA Oncol. 2021;7(9):1402-1403. doi:10.1001/jamaoncol.2021.2043

To the Editor Reinisch et al1 recently reported a randomized clinical trial evaluating the efficacy of endocrine therapy in treating breast cancer in men. Their primary objective was to compare changes in estradiol concentrations within 3 treatment arms; their secondary objectives included measuring changes in concentration of several hormonal biomarkers. Although we greatly appreciate the authors’ efforts to perform this study, we were surprised and disappointed by the absence of any information on the analytical methods used to measure the hormone concentrations. The method used to quantify any biomarker, and especially hormones, can significantly affect study outcome and replication.2 Analytical methods may differ in accuracy of the obtained test results, sensitivity and specificity for the biomarker, analytical traceability, and standardization required for translation to other methods.2 Therefore, adequate reporting of the analytical method used is essential if the obtained results are to be properly assessed and replicated.

Add or change institution
Limit 200 characters
Limit 25 characters
Conflicts of Interest Disclosure

Identify all potential conflicts of interest that might be relevant to your comment.

Conflicts of interest comprise financial interests, activities, and relationships within the past 3 years including but not limited to employment, affiliation, grants or funding, consultancies, honoraria or payment, speaker's bureaus, stock ownership or options, expert testimony, royalties, donation of medical equipment, or patents planned, pending, or issued.

Err on the side of full disclosure.

If you have no conflicts of interest, check "No potential conflicts of interest" in the box below. The information will be posted with your response.

Not all submitted comments are published. Please see our commenting policy for details.

Limit 140 characters
Limit 3600 characters or approximately 600 words
    ×