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1.
PLoS One ; 18(2): e0281365, 2023.
Article in English | MEDLINE | ID: mdl-36763574

ABSTRACT

BACKGROUND: As diagnostic tests for COVID-19 were broadly deployed under Emergency Use Authorization, there emerged a need to understand the real-world utilization and performance of serological testing across the United States. METHODS: Six health systems contributed electronic health records and/or claims data, jointly developed a master protocol, and used it to execute the analysis in parallel. We used descriptive statistics to examine demographic, clinical, and geographic characteristics of serology testing among patients with RNA positive for SARS-CoV-2. RESULTS: Across datasets, we observed 930,669 individuals with positive RNA for SARS-CoV-2. Of these, 35,806 (4%) were serotested within 90 days; 15% of which occurred <14 days from the RNA positive test. The proportion of people with a history of cardiovascular disease, obesity, chronic lung, or kidney disease; or presenting with shortness of breath or pneumonia appeared higher among those serotested compared to those who were not. Even in a population of people with active infection, race/ethnicity data were largely missing (>30%) in some datasets-limiting our ability to examine differences in serological testing by race. In datasets where race/ethnicity information was available, we observed a greater distribution of White individuals among those serotested; however, the time between RNA and serology tests appeared shorter in Black compared to White individuals. Test manufacturer data was available in half of the datasets contributing to the analysis. CONCLUSION: Our results inform the underlying context of serotesting during the first year of the COVID-19 pandemic and differences observed between claims and EHR data sources-a critical first step to understanding the real-world accuracy of serological tests. Incomplete reporting of race/ethnicity data and a limited ability to link test manufacturer data, lab results, and clinical data challenge the ability to assess the real-world performance of SARS-CoV-2 tests in different contexts and the overall U.S. response to current and future disease pandemics.


Subject(s)
COVID-19 , SARS-CoV-2 , Humans , United States/epidemiology , SARS-CoV-2/genetics , COVID-19/diagnosis , COVID-19/epidemiology , RNA , Pandemics , COVID-19 Testing
2.
J Biopharm Stat ; 26(1): 17-29, 2016.
Article in English | MEDLINE | ID: mdl-26372792

ABSTRACT

Evaluation of safety is a critical component of drug review at the US Food and Drug Administration (FDA). Statisticians are playing an increasingly visible role in quantitative safety evaluation and regulatory decision-making. This article reviews the history and the recent events relating to quantitative drug safety evaluation at the FDA. The article then focuses on five active areas of quantitative drug safety evaluation and the role Division of Biometrics VII (DBVII) plays in these areas, namely meta-analysis for safety evaluation, large safety outcome trials, post-marketing requirements (PMRs), the Sentinel Initiative, and the evaluation of risk from extended/long-acting opioids. This article will focus chiefly on developments related to quantitative drug safety evaluation and not on the many additional developments in drug safety in general.


Subject(s)
Legislation, Drug/trends , Pharmaceutical Preparations/standards , Safety/legislation & jurisprudence , Safety/standards , Biometry , Humans , Meta-Analysis as Topic , United States , United States Food and Drug Administration
3.
Biomark Med ; 9(11): 1095-105, 2015.
Article in English | MEDLINE | ID: mdl-26526897

ABSTRACT

The traditional route for regulatory acceptance of biomarkers in drug development is through submission of biomarker data in drug approval submissions in the context of a single drug development program. The US FDA's Critical Path Initiative called for establishment of a biomarker qualification process to enable progress in the drug development paradigm. In response to this, the Center for Drug Evaluation and Research (CDER) established a Biomarker Qualification Program (BQP) to qualify a biomarker for a specific context of use (COU). The qualified biomarker can then be used in multiple drug development programs for this COU without re-review. Here, we describe some of the features of the BQP and two new initiatives that have the potential to aid biomarker development through early interactions with the FDA. Finally, we discuss some of the feedback the FDA has received from submitters and the BQP's actions to strengthen the program.


Subject(s)
Biomarkers/analysis , Social Control, Formal , Child , Clinical Trials as Topic , Drug Discovery , Humans , Internationality , Public Health , Risk , Statistics as Topic
4.
Adverse Drug React Toxicol Rev ; 21(1-2): 101-7, 2002.
Article in English | MEDLINE | ID: mdl-12140903

ABSTRACT

OBJECTIVE: Reports of cefotetan-associated haemolytic anaemia have prompted a US Food and Drug Administration (FDA) review of the overall number, severity, and causality of such cases. METHODS/RESULTS: A search of the FDA's Spontaneous Reporting System and the World Health Organization's database revealed 85 cases of haemolytic anaemia since the approval of cefotetan in 1985, 15 of them fatal. Moderate to severe haemolysis was reflected in a mean fall in haemoglobin levels by 6.65 mg/dl (n = 20) and a mean final haemoglobin concentration of 5.2 mg/dl (n = 52). Transfusion of packed red blood cells was required in 47 patients (55.3%). New onset renal dysfunction was noted in 7 patients (8.2%). The direct antiglobulin test was positive in 50 patients (59%), and serological studies revealed antibodies to cefotetan in 30 patients (35%). CONCLUSION: These data suggest that treatment with cefotetan may induce severe autoimmune haemolytic anaemia.


Subject(s)
Anemia, Hemolytic, Autoimmune/chemically induced , Cefotetan/adverse effects , Cephamycins/adverse effects , Acute Kidney Injury/chemically induced , Adult , Aged , Aged, 80 and over , Anemia, Hemolytic, Autoimmune/epidemiology , Anemia, Hemolytic, Autoimmune/mortality , Cephalosporins/adverse effects , Female , Hemoglobins/metabolism , Hemolysis , Humans , Male , Middle Aged , Renal Dialysis , Time Factors , United States/epidemiology , United States Food and Drug Administration , World Health Organization
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