Heather Stone - Academia.edu (original) (raw)

Papers by Heather Stone

Research paper thumbnail of Analysis of factors associated with tuberculosis outcomes in District Kullu, India

Research paper thumbnail of 627. CURE ID as a Tool for Curating and Analyzing Drugs Used in COVID-19 Clinical Trials

Open Forum Infectious Diseases, 2021

Background CURE ID is an internet-based data repository (https://cure.ncats.io/explore) developed... more Background CURE ID is an internet-based data repository (https://cure.ncats.io/explore) developed collaboratively by FDA and NCATS/NIH. It is designed to capture real-world clinical outcome data to advance drug repurposing and to inform future clinical trials for infectious diseases with high unmet medical need. It also serves as a repository of clinical trials automatically pulled from https://www.clinicaltrials.gov into the CURE ID platform, where they were then manually curated, with the intention of keeping the infectious diseases community updated on the various clinical trials underway. The current study is a descriptive analysis of various therapeutics in clinical trials against COVID-19 on the CURE ID platform. Methods Using clinicaltrials.gov we selected those trials addressing therapeutics for COVID-19 and reviewed the drugs used, the current status of the trials, and the phases of development. Results As of May 2021, we identified 2,154 clinical trials and 933 drugs from ...

Research paper thumbnail of 546. Capturing Clinician’s Experiences Repurposing Drugs to Inform Future Studies During COVID-19

Open Forum Infectious Diseases, 2020

Background CURE ID is an internet-based repository developed collaboratively by FDA and NCATS/NIH... more Background CURE ID is an internet-based repository developed collaboratively by FDA and NCATS/NIH, with the support of WHO and IDSA. It encourages clinicians globally to share novel uses of existing drugs for patients with difficult-to-treat infections. It is designed to serve as a rapid communication platform for healthcare providers during an outbreak, providing for systematic case-sharing, discussion, and the latest literature. Besides case reports, CURE ID offers a discussion platform for clinicians, disease-specific clinical trials curated from clincialtrials.gov, and a newsfeed that shows relevant journal articles and news related to COVID-19 and other infectious diseases. Methods The CURE ID team extracted individual case reports on patient-level treatments and outcomes of COVID-19 infection from the published literature and gathered clinician-submitted cases through the electronic case report form. Additionally, CURE ID partnered with the University of Pennsylvania’s CORONA ...

Research paper thumbnail of Collaborative Use Repurposing Engine (CURE): FDA-NCATS/NIH Effort to Capture the Global Clinical Experience of Drug Repurposing to Facilitate Development of New Treatments for Neglected and Emerging Infectious Diseases

Open Forum Infectious Diseases, 2017

Background Repurposing approved products has proven a critical strategy to serve unmet medical ne... more Background Repurposing approved products has proven a critical strategy to serve unmet medical needs. Historically, 40% of drugs approved for treatment of tropical diseases were repurposed, including albendazole for echinococcosis and neurocysticercosis, and azithromycin for trachoma. Advantages of repurposing include that approved drugs are well characterized, do not require expensive development programs needed for new drugs, and are frequently active against multiple diseases. Owing to the limited number of drugs approved to treat neglected tropical diseases (NTDs) and emerging or drug-resistant infections, healthcare practitioners use existing drugs in novel ways to treat patients with these conditions. This clinical experience, regardless of whether the outcomes are positive or negative, often is not reported or shared, and the knowledge is therefore lost. Methods FDA and NCATS/NIH have built a pilot program called Collaborative Use Repurposing Engine (CURE) to capture and cent...

Research paper thumbnail of 1380. Safety of Repurposed Drugs for Multidrug-Resistant and Extensively Drug-Resistant Tuberculosis: An Analysis of Adverse Events Reported in the Literature

Open Forum Infectious Diseases, 2019

Background Multi and extensively drug-resistant (MDR and XDR) tuberculosis (TB) remains a treatme... more Background Multi and extensively drug-resistant (MDR and XDR) tuberculosis (TB) remains a treatment challenge due to drug adverse events (AEs) and long regimens. Our aim was to identify AEs which resulted from repurposing drugs for MDR and XDR-TB. Methods A PubMed search for case reports of repurposed drugs for MDR and XDR-TB from January 1, 2014 to October 23, 2018 identified 130 patients (78 MDR, 52 XDR) in 91 articles. There were 31 extrapulmonary, 81 pulmonary TB cases, and 18 with both. Drugs were regarded as repurposed if they were either not approved for TB by the FDA, or they were approved for TB but were used in novel populations, novel combinations, or nonstandard doses. Drug labels were reviewed for AEs. Results Linezolid (n = 65) and moxifloxacin (n = 48) were the most commonly repurposed drugs. The following were also frequently used: clofazimine (n = 47), levofloxacin (n = 45), amikacin (n = 43), amoxicillin-clavulanate (n = 40), kanamycin (n = 36), carbapenems (n = 22...

Research paper thumbnail of Analysis of factors associated with tuberculosis outcomes in District Kullu, India

Research paper thumbnail of 627. CURE ID as a Tool for Curating and Analyzing Drugs Used in COVID-19 Clinical Trials

Open Forum Infectious Diseases, 2021

Background CURE ID is an internet-based data repository (https://cure.ncats.io/explore) developed... more Background CURE ID is an internet-based data repository (https://cure.ncats.io/explore) developed collaboratively by FDA and NCATS/NIH. It is designed to capture real-world clinical outcome data to advance drug repurposing and to inform future clinical trials for infectious diseases with high unmet medical need. It also serves as a repository of clinical trials automatically pulled from https://www.clinicaltrials.gov into the CURE ID platform, where they were then manually curated, with the intention of keeping the infectious diseases community updated on the various clinical trials underway. The current study is a descriptive analysis of various therapeutics in clinical trials against COVID-19 on the CURE ID platform. Methods Using clinicaltrials.gov we selected those trials addressing therapeutics for COVID-19 and reviewed the drugs used, the current status of the trials, and the phases of development. Results As of May 2021, we identified 2,154 clinical trials and 933 drugs from ...

Research paper thumbnail of 546. Capturing Clinician’s Experiences Repurposing Drugs to Inform Future Studies During COVID-19

Open Forum Infectious Diseases, 2020

Background CURE ID is an internet-based repository developed collaboratively by FDA and NCATS/NIH... more Background CURE ID is an internet-based repository developed collaboratively by FDA and NCATS/NIH, with the support of WHO and IDSA. It encourages clinicians globally to share novel uses of existing drugs for patients with difficult-to-treat infections. It is designed to serve as a rapid communication platform for healthcare providers during an outbreak, providing for systematic case-sharing, discussion, and the latest literature. Besides case reports, CURE ID offers a discussion platform for clinicians, disease-specific clinical trials curated from clincialtrials.gov, and a newsfeed that shows relevant journal articles and news related to COVID-19 and other infectious diseases. Methods The CURE ID team extracted individual case reports on patient-level treatments and outcomes of COVID-19 infection from the published literature and gathered clinician-submitted cases through the electronic case report form. Additionally, CURE ID partnered with the University of Pennsylvania’s CORONA ...

Research paper thumbnail of Collaborative Use Repurposing Engine (CURE): FDA-NCATS/NIH Effort to Capture the Global Clinical Experience of Drug Repurposing to Facilitate Development of New Treatments for Neglected and Emerging Infectious Diseases

Open Forum Infectious Diseases, 2017

Background Repurposing approved products has proven a critical strategy to serve unmet medical ne... more Background Repurposing approved products has proven a critical strategy to serve unmet medical needs. Historically, 40% of drugs approved for treatment of tropical diseases were repurposed, including albendazole for echinococcosis and neurocysticercosis, and azithromycin for trachoma. Advantages of repurposing include that approved drugs are well characterized, do not require expensive development programs needed for new drugs, and are frequently active against multiple diseases. Owing to the limited number of drugs approved to treat neglected tropical diseases (NTDs) and emerging or drug-resistant infections, healthcare practitioners use existing drugs in novel ways to treat patients with these conditions. This clinical experience, regardless of whether the outcomes are positive or negative, often is not reported or shared, and the knowledge is therefore lost. Methods FDA and NCATS/NIH have built a pilot program called Collaborative Use Repurposing Engine (CURE) to capture and cent...

Research paper thumbnail of 1380. Safety of Repurposed Drugs for Multidrug-Resistant and Extensively Drug-Resistant Tuberculosis: An Analysis of Adverse Events Reported in the Literature

Open Forum Infectious Diseases, 2019

Background Multi and extensively drug-resistant (MDR and XDR) tuberculosis (TB) remains a treatme... more Background Multi and extensively drug-resistant (MDR and XDR) tuberculosis (TB) remains a treatment challenge due to drug adverse events (AEs) and long regimens. Our aim was to identify AEs which resulted from repurposing drugs for MDR and XDR-TB. Methods A PubMed search for case reports of repurposed drugs for MDR and XDR-TB from January 1, 2014 to October 23, 2018 identified 130 patients (78 MDR, 52 XDR) in 91 articles. There were 31 extrapulmonary, 81 pulmonary TB cases, and 18 with both. Drugs were regarded as repurposed if they were either not approved for TB by the FDA, or they were approved for TB but were used in novel populations, novel combinations, or nonstandard doses. Drug labels were reviewed for AEs. Results Linezolid (n = 65) and moxifloxacin (n = 48) were the most commonly repurposed drugs. The following were also frequently used: clofazimine (n = 47), levofloxacin (n = 45), amikacin (n = 43), amoxicillin-clavulanate (n = 40), kanamycin (n = 36), carbapenems (n = 22...