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  1. Abstract Commonly used data citation practices rely on unverifiable retrieval methods which are susceptible to content drift, which occurs when the data associated with an identifier have been allowed to change. Based on our earlier work on reliable dataset identifiers, we propose signed citations, i.e., customary data citations extended to also include a standards-based, verifiable, unique, and fixed-length digital content signature. We show that content signatures enable independent verification of the cited content and can improve the persistence of the citation. Because content signatures are location- and storage-medium-agnostic, cited data can be copied to new locations to ensure their persistence across current and future storage media and data networks. As a result, content signatures can be leveraged to help scalably store, locate, access, and independently verify content across new and existing data infrastructures. Content signatures can also be embedded inside content to create robust, distributed knowledge graphs that can be cited using a single signed citation. We describe applications of signed citations to solve real-world data collection, identification, and citation challenges. 
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    Free, publicly-accessible full text available December 1, 2024
  2. Free, publicly-accessible full text available May 1, 2024
  3. Abstract

    Valid surrogate endpoints S can be used as a substitute for a true outcome of interest T to measure treatment efficacy in a clinical trial. We propose a causal inference approach to validate a surrogate by incorporating longitudinal measurements of the true outcomes using a mixed modeling approach, and we define models and quantities for validation that may vary across the study period using principal surrogacy criteria. We consider a surrogate-dependent treatment efficacy curve that allows us to validate the surrogate at different time points. We extend these methods to accommodate a delayed-start treatment design where all patients eventually receive the treatment. Not all parameters are identified in the general setting. We apply a Bayesian approach for estimation and inference, utilizing more informative prior distributions for selected parameters. We consider the sensitivity of these prior assumptions as well as assumptions of independence among certain counterfactual quantities conditional on pretreatment covariates to improve identifiability. We examine the frequentist properties (bias of point and variance estimates, credible interval coverage) of a Bayesian imputation method. Our work is motivated by a clinical trial of a gene therapy where the functional outcomes are measured repeatedly throughout the trial.

     
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