Quantum Leap Healthcare Collaborative Announces Termination of the Cyclosporine Treatment Arm for Critically Ill COVID-19 Patients in the I-SPY COVID Trial
Quantum Leap Healthcare Collaborative (QLHC), sponsor of the I-SPY COVID Trial, announces that the cyclosporine arm of the study has been terminated for futility. Cyclosporine, a calcineurin inhibitor and a well-known and commonly prescribed immunosuppressant medication, is best known for its efficacy in the prevention of solid organ transplant rejection.
UCSF and I-SPY 2 Breast Cancer Researchers Develop Newly Redefined Breast Cancer Response Subtypes
Research scientists and statisticians from UC San Francisco have developed improved biomarker classifications as part of their research results in the I-SPY 2 trial for high-risk breast cancer patients. The new cancer response subtypes reflect responsiveness to drug treatments and are intended to help clinicians be more precise in how they target therapies.
NEJM Authors’ Perspective cites FDA collaboration with OneSource in discussion about Real World Evidence
More than 5 years after the passage of the 21st Century Cures Act of 2016, the terms “real-world data” (RWD) and “real-world evidence” (RWE) are being used inconsistently and sometimes interchangeably. This imprecision has complicated efforts to assess the impact of such data and evidence and hindered attempts to track their use.
Quantum Leap Healthcare Collaborative™ Announces OneSource as a Grand Prize Winner in the 2022 Bio-IT World Innovative Practices Awards
Quantum Leap Healthcare Collaborative™ (QLHC) announces the award of OneSource, Quantum Leap Healthcare Collaborative’s groundbreaking clinical trial data management solution developed in collaboration with OpenClinica as the grand prize winner at the 2022 Bio-IT World Innovative Practices award in the Clinical & Health-IT category. By integrating clinical trial data systems directly with existing electronic health records, OneSource achieves new levels of efficiency and quality control for clinical trial data management.
Natera to Present Data from the BEATRICE and I-SPY2 Trials in Early-Stage TNBC and HR+/HER2- Breast Cancer at the 2022 AACR Annual Meeting
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced that it will present new data relating to its personalized and tumor-informed molecular residual disease (MRD) test, Signatera™, at the annual meeting of the American Association for Cancer Research taking place April 8 – 13, 2022.
OneSource Named a 2022 Innovative Practices Award Winner by Bio-IT World
Bio-ITWorld today announced the 2022 Innovative Practices Awards winners. Four grand prize awards were granted to AstraZeneca, Guardant Health with IQVIA, Merck KGaA, Darmstadt, Germany, with Genedata, and Quantum Leap Healthcare Collaborative / University of California San Francisco with OpenClinica. The awards ceremony will be held during the plenary program on Tuesday, May 3, at the 2022 Bio-IT World Conference & Expo in Boston.
UCSF, QLHC and FDA Announce Successful Deployment of Innovative Data Capture System for Clinical Care and Research
UC San Francisco (UCSF), in collaboration with the Quantum Leap Healthcare Collaborative (QLHC) and the U.S. Food and Drug Administration (FDA), has developed the OneSource system to seamlessly integrate clinical care and research data.
OneSource is an electronic data capture (EDC) system which was developed with the goal of radically streamlining the collection and distribution of patient health data for clinical trials. It is based on best practices and open-source data Electronic Health Record (EHR) integration standards to launch seamlessly within widely used EHR platforms.
I-SPY COVID Trial Sponsored by Quantum Leap Healthcare Collaborative Suggests No Clinical Benefit with Addition of Nebulized ZYESAMI When Given by Mouth in Critically Ill Patients with COVID-19
Quantum Leap Healthcare Collaborative (QLHC) announced in collaboration with NRx Pharmaceuticals, Inc. (NRx), that the nebulized form of ZYESAMI® (Aviptadil), in the I-SPY COVID Trial of Critical COVID-19 patients has been stopped. The I-SPY COVID Trial, (NCT04488081) is a phase 2, open label, adaptive platform trial designed to rapidly screen potential agents that could substantially improve treatment for severely and critically ill COVID-19 patients. QLHC is the sponsor of the I-SPY COVID TRIAL.
No Clinical Benefit Suggested by Addition of Pulmozyme® to Treatment of Critically Ill Patients With COVID-19 in I-SPY COVID Trial
Today Quantum Leap Healthcare Collaborative (QLHC), sponsor of the I-SPY COVID Trial, announced that the Pulmozyme® (dornase alfa) arm of the trial has been terminated. The interim analysis suggests that the addition of Pulmozyme® to treatment of critically ill patients with COVID-19 is unlikely to achieve statistically significant improvement in efficacy.
I-SPY COVID Trial Suggests No Clinical Benefit from Addition of IC14 to Treatment of Critically Ill Patients with COVID-19
Today Quantum Leap Healthcare Collaborative (QLHC), sponsor of the I-SPY COVID Trial, announced that the IC14 arm of the trial has been terminated. This decision was due to the high probability that IC14 would not have a large impact on either shortening time to recovery or mortality in critically ill patients with COVID-19.
