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The Inclusion of Molecular Diagnostic Testing in Comparative Effectiveness Studies

Posted Jul 02 2009 6:32pm

I have made the point in previous notes that clinical lab testing, particularly molecular diagnostics, will comprise a key component of most comparative effectiveness research (CER). See, for example, the following: Comparative Effectiveness, Healthcare Cost Reduction, and Virtual Decision Trees; A Look at Deloitte's Healthcare Reform Pyramid: A Strategy for Reducing Costs; Moving Resources from the Therapeutic to the Diagnostic Silo; Biomarkers Used to Assess Treatment Efficacy. I suspect that most lab professionals assume that this same conclusion will be reached quickly by most comparative effectiveness researchers. Nevertheless, I was encouraged that the Association for Molecular Pathology (AMP) took advantage of the surge in CER funds to submit a letter to the Federal Coordinating Council for Comparative Effectiveness Research to make this very point (see: AMP urges inclusion of molecular diagnostic tests in comparative effectiveness research ). Below is an excerpt from the article describing this letter:

The AMP letter recommends the development of a model process for CER regarding clinical laboratory tests. This model should include the creation of a panel of experts consisting of physicians and scientists, including laboratorians with molecular diagnostics expertise, economists, and reimbursement specialists; the creation of an electronic clearinghouse for information on CER projects similar to clinicaltrials.gov; the development and adoption of standards for the collection and storage of data from genetic testing laboratories in order to facilitate interoperability among databases; and a requirement that data from technologies and tests being assessed be generated from CLIA-, CAP-, ISO-, or FDA- certified institutions. Additionally, AMP wrote that in order to routinely incorporate information that relates patient outcomes to genetic variations into clinical care, there is a need to jointly fund large, carefully designed comparative effectiveness trials for molecular tests with observational comparative effectiveness studies that complement the randomized controlled trials by including patients who do not necessarily meet the inclusion criteria for traditional prospective trials.

For the sake of efficiency, let me distill from this article the key recommendations made by AMP retarding all comparative effectiveness research (CER) going forward:

  • Development of a model process for CER regarding clinical laboratory tests
  • Creation of an electronic clearinghouse for information on CER projects 
  • Development and adoption of standards for the collection and storage of data from genetic testing laboratories
  • Requirement that data for studies be generated by CLIA-, CAP-, ISO-, or FDA- certified labs
  • Need to fund comparative effectiveness trials with observational comparative effectiveness studies that complement the randomized controlled trials

I personally find all of these recommendation eminently reasonable. I believe that there are a number of parallels between evidence-based medicine (EBM) and comparative effectiveness research (CER). I have been critical about EBM research in the past (see, for example, Flaws in Evidence-Based Medicine ). Part of my criticism of EBM studies, and perhaps of CER of the future, is that they have taken too long to perform and established an overly rigid a set of conditions such that their results have not been generally applicable in clinical practice and thus frequently ignored. The recommendations of AMP about future CER such as the use of a model process, the establishment of an electronic clearing house on the web, and the need for observational studies can help to ameliorate some of these problems.

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