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Using earlier measures in a longitudinal sequence as a potential surrogate for a later one

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  • Pryseley, Assam
  • Tilahun, Abel
  • Alonso, Ariel
  • Molenberghs, Geert

Abstract

The number of potential surrogate markers for clinical-trial endpoints is increasing rapidly, not in the least owing to the availability of biomarkers. At the same time, considerable development has taken place regarding statistical evaluation paradigms for such markers. As a consequence, such endpoints are given more extensive consideration for practice than previously had been the case. A particular but important instance is where the true endpoint is the ultimate assessment in a sequence of repeated measures. It is then appealing to consider earlier measures, either in isolation or several combined, as a potential surrogate endpoint. The length and cost reducing potential has to be weighed carefully against loss in precision and the risks of an inappropriate decision regarding a new compound's fate. Quantitative criteria to do so are developed, embedded in a meta-analytic framework. The methodology's behavior is assessed through simulations and applied to data from a pair of clinical trials, one in ophthalmology and one in schizophrenia.

Suggested Citation

  • Pryseley, Assam & Tilahun, Abel & Alonso, Ariel & Molenberghs, Geert, 2010. "Using earlier measures in a longitudinal sequence as a potential surrogate for a later one," Computational Statistics & Data Analysis, Elsevier, vol. 54(5), pages 1342-1354, May.
    • Handle: RePEc:eee:csdana:v:54:y:2010:i:5:p:1342-1354
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    References listed on IDEAS

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    1. Ariel Alonso & Helena Geys & Geert Molenberghs & Michael G. Kenward & Tony Vangeneugden, 2004. "Validation of Surrogate Markers in Multiple Randomized Clinical Trials with Repeated Measurements: Canonical Correlation Approach," Biometrics, The International Biometric Society, vol. 60(4), pages 845-853, December.
    2. Tilahun, Abel & Pryseley, Assam & Alonso, Ariel & Molenberghs, Geert, 2007. "Flexible surrogate marker evaluation from several randomized clinical trials with continuous endpoints, using R and SAS," Computational Statistics & Data Analysis, Elsevier, vol. 51(9), pages 4152-4163, May.
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    Cited by:

    1. Sotiris Bersimis & Athanasios Sachlas & Takis Papaioannou, 2018. "Monitoring Phase II Comparative Clinical Trials with Two Endpoints and Penalty for Adverse Events," Methodology and Computing in Applied Probability, Springer, vol. 20(2), pages 719-738, June.
    2. Denis Agniel & Layla Parast, 2021. "Evaluation of longitudinal surrogate markers," Biometrics, The International Biometric Society, vol. 77(2), pages 477-489, June.

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