Jay Park
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View article: Estimands and their implications for evidence synthesis for oncology: A simulation study of treatment switching in meta-analysis
Estimands and their implications for evidence synthesis for oncology: A simulation study of treatment switching in meta-analysis Open
The ICH E9(R1) addendum provides guidelines on accounting for intercurrent events in clinical trials using the estimands framework. However, there has been limited attention to the estimands framework for meta-analysis. Using treatment swi…
View article: Target Aggregate Data Adjustment Method for Transportability Analysis Utilizing Summary‐Level Data From the Target Population
Target Aggregate Data Adjustment Method for Transportability Analysis Utilizing Summary‐Level Data From the Target Population Open
Transportability analysis is a causal inference framework used to evaluate the external validity of studies by transporting treatment effects from a study sample to an external target population by adjusting for differences in the distribu…
View article: Systematic review of applied transportability and generalizability analyses: A landscape analysis
Systematic review of applied transportability and generalizability analyses: A landscape analysis Open
Transportability and generalizability analysis are novel causal inference methods that quantitatively assess external validity. Currently, it is unclear how these analyses are applied in practice. To characterize applications and methods, …
View article: Target Aggregate Data Adjustment Method for Transportability Analysis Utilizing Summary-Level Data from the Target Population
Target Aggregate Data Adjustment Method for Transportability Analysis Utilizing Summary-Level Data from the Target Population Open
Transportability analysis is a causal inference framework used to evaluate the external validity of randomized clinical trials (RCTs) or observational studies. Most existing transportability analysis methods require individual patient-leve…
View article: Estimands and Their Implications for Evidence Synthesis for Oncology: A Simulation Study of Treatment Switching in Meta-Analysis
Estimands and Their Implications for Evidence Synthesis for Oncology: A Simulation Study of Treatment Switching in Meta-Analysis Open
The ICH E9(R1) addendum provides guidelines on accounting for intercurrent events in clinical trials using the estimands framework. However, there has been limited attention to the estimands framework for meta-analysis. Using treatment swi…
View article: Matched vs Nonmatched Placebos in a Randomized Trial of COVID-19 Treatments
Matched vs Nonmatched Placebos in a Randomized Trial of COVID-19 Treatments Open
Importance Matched placebo interventions are complex and resource intensive. Recent evidence suggests matched placebos may not always be necessary. Previous studies have predominantly evaluated potential bias of nonmatched placebos (ie, di…
View article: Adaptive designs in public health: Vaccine and cluster randomized trials go Bayesian
Adaptive designs in public health: Vaccine and cluster randomized trials go Bayesian Open
Clinical trials in public health—particularly those conducted in low‐ and middle‐income countries—often involve communicable and non‐communicable diseases with high disease burden and unmet needs. Trials conducted in these regions often ar…
View article: Assessing the performance of group‐based trajectory modeling method to discover different patterns of medication adherence
Assessing the performance of group‐based trajectory modeling method to discover different patterns of medication adherence Open
It is well known that medication adherence is critical to patient outcomes and can decrease patient mortality. The Pharmacy Quality Alliance (PQA) has recognized and identified medication adherence as an important indicator of medication‐u…
View article: Benefit-Risk Assessment of Medical Products Using Bayesian Multi-Criteria Augmented Decision Analysis for Clinical Development
Benefit-Risk Assessment of Medical Products Using Bayesian Multi-Criteria Augmented Decision Analysis for Clinical Development Open
Multi-criteria decision analysis (MCDA) is a benefit-risk assessment tool that evaluates multiple competing benefit and risk endpoints simultaneously. MCDA has the potential to aid sponsors in making effective and informed go/no-go decisio…
View article: Improving the efficiency of clinical trials in multiple sclerosis
Improving the efficiency of clinical trials in multiple sclerosis Open
Background: Phase 3 clinical trials for disease-modifying therapies in relapsing-remitting multiple sclerosis (RRMS) have utilized a limited number of conventional designs with a high degree of success. However, these designs limit the typ…
View article: The role of CXCL1 in crosstalk between endocrine resistant breast cancer and fibroblast
The role of CXCL1 in crosstalk between endocrine resistant breast cancer and fibroblast Open
Background : ER positive breast cancer is currently targeted using various endocrine therapies. Despite the proven therapeutic efficacy, resistance to the drug and reoccurrence of tumor appears to be a complication that many patients deal …
View article: The Role of Medical Students in Global Pediatric Neurosurgery
The Role of Medical Students in Global Pediatric Neurosurgery Open
Objective: Medical students are important for the long-term efficacy of global pediatric neurosurgery initiatives. In this manuscript, we describe the rationale for mobilizing medical students in global pediatric neurosurgery, delineate th…
View article: Economic Evaluation of Cost and Time Required for a Platform Trial vs Conventional Trials
Economic Evaluation of Cost and Time Required for a Platform Trial vs Conventional Trials Open
Although setting up platform trials can take longer and be costly, the findings of this study suggest that having a single infrastructure can improve efficiencies with respect to costs and efforts.
View article: Dynamical clustering of U.S. states reveals four distinct infection patterns that predict SARS-CoV-2 pandemic behavior
Dynamical clustering of U.S. states reveals four distinct infection patterns that predict SARS-CoV-2 pandemic behavior Open
The SARS-CoV-2 pandemic has so far unfolded diversely across the fifty United States of America, reflected both in different time progressions of infection "waves" and in magnitudes of local infection rates. Despite a marked diversity of p…
View article: The Need for a Practical Approach to Evaluate the Effectiveness of COVID-19 Vaccines for Low- and Middle-Income Countries
The Need for a Practical Approach to Evaluate the Effectiveness of COVID-19 Vaccines for Low- and Middle-Income Countries Open
The global demand for coronavirus disease 2019 (COVID-19) vaccines currently far outweighs the available global supply and manufacturing capacity. As a result, securing doses of vaccines for low- and middle-income countries has been challe…
View article: Effect of Early Treatment With Hydroxychloroquine or Lopinavir and Ritonavir on Risk of Hospitalization Among Patients With COVID-19
Effect of Early Treatment With Hydroxychloroquine or Lopinavir and Ritonavir on Risk of Hospitalization Among Patients With COVID-19 Open
ClinicalTrials.gov Identifier: NCT04403100.
View article: The role and challenges of cluster randomised trials for global health
The role and challenges of cluster randomised trials for global health Open
Evaluating whether an intervention works when trialled in groups of individuals can pose complex challenges for clinical research. Cluster randomised controlled trials involve the random allocation of groups or clusters of individuals to r…
View article: Randomised trials at the level of the individual
Randomised trials at the level of the individual Open
In global health research, short-term, small-scale clinical trials with fixed, two-arm trial designs that generally do not allow for major changes throughout the trial are the most common study design. Building on the introductory paper of…
View article: Clinical Trial Data Sharing for COVID-19–Related Research
Clinical Trial Data Sharing for COVID-19–Related Research Open
This paper aims to provide a perspective on data sharing practices in the context of the COVID-19 pandemic. The scientific community has made several important inroads in the fight against COVID-19, and there are over 2500 clinical trials …
View article: A master protocol of an adaptive platform trial to assess effectiveness of multi-component interventions for linear growth of sub-Saharan African children during complementary feeding period
A master protocol of an adaptive platform trial to assess effectiveness of multi-component interventions for linear growth of sub-Saharan African children during complementary feeding period Open
Randomized clinical trials (RCT) are an important tool that has led to important reduction of global childhood mortality. Low and middle-income countries (LMICs) still face important challenge in stunting (low height-for-age) that can prod…
View article: Clinical Trial Data Sharing for COVID-19–Related Research (Preprint)
Clinical Trial Data Sharing for COVID-19–Related Research (Preprint) Open
UNSTRUCTURED This paper aims to provide a perspective on data sharing practices in the context of the COVID-19 pandemic. The scientific community has made several important inroads in the fight against COVID-19, and there are over 2500 cl…
View article: The Landscape of Emerging Randomized Clinical Trial Evidence for COVID-19 Disease Stages: A Systematic Review of Global Trial Registries
The Landscape of Emerging Randomized Clinical Trial Evidence for COVID-19 Disease Stages: A Systematic Review of Global Trial Registries Open
There is a marked difference in the number of trials across settings, with limited studies on non-hospitalized persons. Focus on pre- and post-exposure, and outpatients, is worthwhile as a means of reducing infections and lessening the hea…