Medical statistics

PT010 Significantly Reduced Rate of Moderate or Severe COPD Exacerbations in Phase III ETHOS Trial

Retrieved on: 
Wednesday, June 24, 2020
Health, Clinical trials, Research, Pharmaceutical, Science, Biotechnology, Health, Clinical research, Medical statistics, Articles, Medical research, Chronic lower respiratory diseases, Clinical trial, Design of experiments, Pharmaceutical industry, Chronic obstructive pulmonary disease, Clinical endpoint

The results of the Phase III ETHOS trial support the strong clinical profile of PT010 in reducing exacerbation rates compared with dual-combination therapies.

Key Points: 
  • The results of the Phase III ETHOS trial support the strong clinical profile of PT010 in reducing exacerbation rates compared with dual-combination therapies.
  • ETHOS is a randomized, double-blinded, multi-center, parallel-group, 52-week trial to assess the efficacy and safety of PT010 in symptomatic patients with moderate to very severe COPD and a history of exacerbation(s) in the previous year.
  • Outcomes in the ETHOS trial included, as a primary endpoint, the rate of moderate or severe exacerbations.
  • ETHOS is part of AstraZenecas ATHENA Phase III clinical trial program for PT010, which included more than 15,500 patients globally across 11 trials.

The Future of Digital Health in Clinical Trials - Can Digital Strategies Improve Clinical Trial Recruitment and Retention

Retrieved on: 
Monday, June 22, 2020
Health, Clinical research, Medical research, Clinical trials, Medical statistics, Articles, Pharmaceutical industry, Clinical endpoint

DUBLIN, June 22, 2020 /PRNewswire/ -- The "Clinical Trial Optimisation with Digital Health" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, June 22, 2020 /PRNewswire/ -- The "Clinical Trial Optimisation with Digital Health" report has been added to ResearchAndMarkets.com's offering.
  • What is the real future for digital in clinical trials?
  • Can Digital Strategies improve Clinical Trial Recruitment and Retention?
  • Will Digital Health Expand Clinical Endpoints for Clinical Trials?

RedHill Biopharma Expands Opaganib COVID-19 Phase 2/3 Study with Clinical Trial Applications in Italy and UK 

Retrieved on: 
Thursday, June 18, 2020
Health, Medicine, Clinical research, Medical statistics, Design of experiments, Clinical pharmacology, Clinical trial, Pharmaceutical industry, Clinical endpoint, Mechanical ventilation

Mark L. Levitt, M.D., Ph.D., Medical Director at RedHill, said: We are quickly advancing the preparations for a global, multi-center powered Phase 2/3 study with opaganib for COVID-19.

Key Points: 
  • Mark L. Levitt, M.D., Ph.D., Medical Director at RedHill, said: We are quickly advancing the preparations for a global, multi-center powered Phase 2/3 study with opaganib for COVID-19.
  • The primary endpoint of the study is to evaluate the proportion of patients requiring intubation and mechanical ventilation by Day 14.
  • The Company currently plans to conduct the study in up to 40 clinical sites across Russia, Italy, the UK and additional countries.
  • In parallel, a randomized, double-blind, placebo-controlled Phase 2a clinical study with opaganib in the U.S. is open for recruitment (NCT04414618) .

C-Path's Transplant Therapeutics Consortium Receives Acceptance of Letter of Intent for iBox Scoring System (Composite Biomarker Panel) as a Reasonably Likely Surrogate Endpoint

Retrieved on: 
Wednesday, June 17, 2020
Medicine, Clinical medicine, Health, Biomarkers, Medical terminology, Clinical trials, Medical statistics, Food and Drug Administration, Surrogate endpoint, Accelerated approval, Organ transplantation, Surrogate

Qualification as a surrogate or reasonably likely surrogate endpoint would allow drug sponsors to pursue accelerated approval, removing a significant barrier to kidney transplant drug development.

Key Points: 
  • Qualification as a surrogate or reasonably likely surrogate endpoint would allow drug sponsors to pursue accelerated approval, removing a significant barrier to kidney transplant drug development.
  • The iBox Scoring System, developed by the Paris Transplant Group, is the first tool of its kind to seek regulatory qualification for use in kidney transplant clinical trials.
  • To date, no biomarkers have been qualified for use as a surrogate or reasonably likely surrogate endpoint in any therapeutic area.
  • The iBox Scoring System has been extensively validated for use in the treatment of individual patients in the clinical care setting.

InflaRx Reports Encouraging Topline Results from the Exploratory Phase II Part of the Adaptive Randomized Phase II/III Trial of IFX-1 in COVID-19

Retrieved on: 
Wednesday, June 17, 2020
Clinical research, Clinical trials, Medical statistics, Health, IFX, Clinical endpoint

The Phase II part of the study evaluated IFX-1 treatment plus best supportive care compared to best supportive care alone for up to 28 days.

Key Points: 
  • The Phase II part of the study evaluated IFX-1 treatment plus best supportive care compared to best supportive care alone for up to 28 days.
  • In IFX-1-treated patients, pulmonary embolisms reported as serious adverse events were lower compared to the best supportive care arm.
  • Upon review of the safety data, the independent data safety monitoring board recommended continuation of the trial into the Phase III part.
  • This Phase II part of the trial was exploratory in nature and was not powered to show statistically significant differences in clinical endpoints.

ABRE Study Meets Primary Safety and Effectiveness Endpoints

Retrieved on: 
Tuesday, June 16, 2020
Clinical trials, Medical statistics, Clinical endpoint, Clinical research, Health

The study met the primary safety and effectiveness endpoints, and the data were presented today virtually via the 2020 Charing Cross Symposium.

Key Points: 
  • The study met the primary safety and effectiveness endpoints, and the data were presented today virtually via the 2020 Charing Cross Symposium.
  • It is encouraging that the study was able to meet its primary endpoints and demonstrated strong results with secondary endpoints.
  • The ABRE Study is a prospective, interventional, single-arm, multi-center, worldwide study, which included 200 subjects with symptomatic iliofemoral venous outflow obstruction from 24 sites throughout the U.S. and Europe.
  • The primary effectiveness endpoint evaluated primary patency at 12 months, and the primary safety endpoint evaluated the incidence of composite Major Adverse Events (MAE) within 30 days following stenting of an obstruction in the iliofemoral venous segment.

Signant Health Expands Its Pioneering Patient Engagement App, TrialGuide, to Enable Remote Participation in Global Clinical Trials

Retrieved on: 
Tuesday, June 16, 2020
Health, Clinical research, Articles, Medical research, Medical statistics, Pharmaceutical industry, Clinical pharmacology, Clinical trial, Design of experiments

Virtual visits provide greater choice for patients and clinicians enhancing the patient experience and supporting trial continuity, now and in the future.

Key Points: 
  • Virtual visits provide greater choice for patients and clinicians enhancing the patient experience and supporting trial continuity, now and in the future.
  • By combining virtual face-to-face communication with appropriate remote assessments and a direct to patient clinical supply chain, Signant Health provides flexibility for patients, sites, and study teams regarding how, and where, clinical research is conducted.
  • In addition to patient engagement, Signant Health's unified suite of patient solutions, including clinical supply chain management and endpoint quality services, have helped customers overcome the unforeseen challenges presented by COVID-19 and prepare for new realities in clinical research by supporting trial continuity and launching clinical trials faster than ever before.
  • Signant Health, a Genstar portfolio company, was created by the merger of industry pioneers CRF Health and Bracket Global.

TrialSpark announces launch of Project Covalence, a clinical trial platform to rapidly test drugs and diagnostics for COVID-19

Retrieved on: 
Tuesday, June 16, 2020
Health, Clinical research, Design of experiments, Medical statistics, Clinical pharmacology, Clinical trial, Pharmaceutical industry, Medical research

Project Covalence provides the technology, clinical operations, and logistical support needed to launch and run COVID-19 clinical trials.

Key Points: 
  • Project Covalence provides the technology, clinical operations, and logistical support needed to launch and run COVID-19 clinical trials.
  • The first study being launched through Project Covalence is an epidemiological longitudinal study led by Dr. Michael Mina of the Harvard T.H.
  • Project Covalence is already collaborating with a number of biopharma companies and organizations running trials for therapeutics, diagnostics, and epidemiological applications.
  • Project Covalence is creating a turnkey trial platform to help us accelerate the development of new treatments, vaccines, and diagnostics."

The Future of Digital Health in Clinical Trials - Hype vs. Reality - ResearchAndMarkets.com

Retrieved on: 
Monday, June 15, 2020
Health, Clinical trials, Health, Medicine, Clinical research, Articles, Medical statistics, Clinical trials, Pharmaceutical industry, Biomarkers, Clinical endpoint, Patient participation, Imaging biomarker

What is the real future for digital in clinical trials?

Key Points: 
  • What is the real future for digital in clinical trials?
  • However, it is too early to prove that a full online-only engagement modality will dramatically increase patient enrollment into clinical trials or retain patients in clinical trials.
  • Will Digital Health Expand Clinical Endpoints for Clinical Trials?
  • Even if we lack best practices at this moment in time, digital biomarkers allow for continuous collection of real-world patient data in clinical trials.

New Pivotal Data Demonstrate Superiority of Apellis’ Pegcetacoplan to Eculizumab in Improving Hemoglobin Levels, Independent of Prior Transfusions, in PNH

Retrieved on: 
Friday, June 12, 2020
Health, Medicine, Clinical trials, Medical statistics, Medical terminology, Immunosuppressants, Clinical endpoint, Clinical research, Efficacy, Eculizumab

Pegcetacoplan also demonstrated a robust response across several key hematologic and clinical measures for PNH.

Key Points: 
  • Pegcetacoplan also demonstrated a robust response across several key hematologic and clinical measures for PNH.
  • Pegcetacoplan met the studys primary endpoint for efficacy, demonstrating superiority to eculizumab with a statistically significant improvement in adjusted means of 3.8 g/dL of hemoglobin at week 16 (p
  • These data reinforce the potential for pegcetacoplan to elevate the standard of care in PNH, and we are in discussions with regulatory authorities to bring pegcetacoplan to the PNH community as quickly as possible.
  • These results demonstrate that pegcetacoplan controls both extravascular and intravascular hemolysis, and has the potential to become a new standard of care for PNH.