BOX 2-1

Stakeholder Perspectives on Evidence

FDA

  • Regulatory decision to approve or clear a diagnostic device for marketing

  • Focused on safety and effectiveness

    • Analytical validity: sufficiently accurate and precise measurement of the analyte

    • Clinical validity: the biological and medical significance of the test result

  • Risk-based classification approach to regulation of devices

  • More complex, higher-risk devices require more substantial levels of evidence

  • Bound by law to declare or decline approval/clearance based on evidence submitted by product sponsor (i.e., no mechanism for provisional approval)

Payers

  • Insurer decision to cover and reimburse the use of a diagnostic device

  • Focused on outcomes

  • Clinical utility: the impact of the test on patient management and outcomes compared with usual care

  • May choose to provisionally cover a test pending collection of further evi­dence of utility (coverage with evidence development)

Evidence-Based Review Groups

  • Independent review of evidence which, in the case of EGAPP or medical professional organizations, can result in practice recommendations

  • Focused on net benefit

    • Balance of benefits or potential benefits with harms or potential harms

  • Recommendations

    • For or against the use of a product based on quality of the evidence and certainty of net benefit

      • No recommendation made in cases of insufficient evidence

      • Applications are further classified as neutral, discouraging, or en­couraging based on contextual factors

      • Products with insufficient but encouraging evidence may merit lim­ited use as additional data are gathered

Providers

  • Focused on value to the individual patient

  • Increase chances of cure/survival/palliation

  • Decrease exposure to toxicity from unnecessary or inappropriate therapy

  • Decision to treat differs from patient to patient

  • Affected by patient, provider, and societal perspectives on risks, benefits, and costs

  • Two patients given the same test result may come to different treatment decisions (regardless of practice recommendations)



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