Structured processes to assess safety, accuracy & effectiveness

Conducting clinical trials for a new diagnostic like a medical test, imaging technique, or medical device typically have a number of different phases.

Development and feasibility assessment

Before initiating clinical trials, researchers and developers work to create and refine the diagnostic test or imaging technique. Preliminary studies may be conducted in a laboratory or with limited patient samples to evaluate feasibility, accuracy, and potential clinical utility.

Analytical validation

This step involves rigorous testing for technical performance of a diagnostic, including sensitivity, specificity, precision, and reliability. Researchers use well-defined samples to assess its ability to detect or measure the target biomarker or condition accurately.

Exploratory clinical studies

Initial clinical studies typically involve a small number of participants, often with the target condition and a control group without the condition. The primary objective is to gather data on diagnostic performance in a real clinical setting, including its sensitivity and specificity. Researchers may refine the parameters and algorithms of the diagnostic based on early findings.

Analytical and clinical validation

Large-scale clinical studies are conducted to further assess the diagnostic's accuracy, safety, and clinical utility. These studies involve a diverse and representative patient population. Researchers compare the diagnostic results to a gold standard or reference test to establish its clinical validity and performance characteristics.

Regulatory submission and review

Data from clinical trials are compiled and submitted to regulatory agencies for review and approval. In the United States, the FDA oversees the approval of diagnostic tests. The regulatory agency evaluates test safety, accuracy, and clinical performance before granting market clearance or approval.

Post-market surveillance (Phase 4)

After approval or clearance, the diagnostic test continues to be monitored in real-world clinical practice. Ongoing data collection helps identify any unforeseen issues, assess long-term performance, and ensure the test remains safe and effective.

Comparative studies

In some cases, additional comparative studies may be conducted to assess the diagnostic’s performance in comparison to existing tests or techniques. These studies can provide valuable information about the test’s added benefits or limitations.

Updates and Refinements

Diagnostic tests may undergo periodic updates and refinements to improve performance or address emerging clinical needs. The specific steps and requirements for clinical trials of a new diagnostic may vary depending on the nature of the test, the target condition, and the regulatory landscape in the country where the trials are conducted. The goal is to demonstrate that the diagnostic is safe, accurate, and clinically valuable for diagnosing or monitoring a specific medical condition.

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