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How to Identify and Manage Risks in Clinical Trial Supplies and Comparator Sourcing: The Benefits of the Global Reach, Upcoming Webinar Hosted by Xtalks

Friday, October 30, 2020 - 12:30pm

It's a complex process of identification and management depending on a number of factors that can impact the effectiveness of the trial.

Key Points: 
  • It's a complex process of identification and management depending on a number of factors that can impact the effectiveness of the trial.
  • Each clinical trial has its own complexities based on the comparator, data and stock shortages which can delay timelines and increase costs.
  • So, what are the risks involved in clinical trial supplies and comparator sourcing and how can you manage these risks to ensure a successful clinical trial on a global scale?
  • For more information or to register for this event, visit How to Identify and Manage Risks in Clinical Trial Supplies and Comparator Sourcing: The Benefits of the Global Reach.

Medidata, TriNetX, and Datavant Partner to Enable Seamless Integration of Real-World Data in Clinical Development

Thursday, October 29, 2020 - 1:00pm

Medidata, a Dassault Systmes company, TriNetX, and Datavant announced a partnership that will accelerate the use of real-world data (RWD) to power clinical research.

Key Points: 
  • Medidata, a Dassault Systmes company, TriNetX, and Datavant announced a partnership that will accelerate the use of real-world data (RWD) to power clinical research.
  • This partnership will enable users of Medidatas end-to-end clinical research platform to securely link their clinical data with patient consent to de-identified patient data without unblinding the study.
  • Pooled clinical trial data is increasingly being used to design synthetic control arms, and even to power algorithms that can predict things like patient drop out.
  • More than one million registered users across 1,600+ customers and partners access the world's most-used platform for clinical development, commercial, and real-world data.

Plus Therapeutics Announces Initiation of Final Cohort of ReSPECT™ Glioblastoma Trial

Thursday, October 29, 2020 - 11:00am

Initiation of the sixth dose cohort follows successful completion of the fifth cohort and clearance from the ReSPECT trials Data and Safety Monitoring Board (DSMB).

Key Points: 
  • Initiation of the sixth dose cohort follows successful completion of the fifth cohort and clearance from the ReSPECT trials Data and Safety Monitoring Board (DSMB).
  • The sixth cohort of the ReSPECT trial includes an increase in both the RNL drug volume and radiation dose to 8.8 milliliters and 22.3 millicuries, respectively.
  • Cohort progression in our ReSPECT trial represents another milestone toward the trials first major readout, said Marc Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics.
  • Plus Therapeutics will be presenting data from the ReSPECT clinical trial at the 2020 Society for Neuro-Oncology (SNO) Annual Meeting being held virtually November 19-21, 2020.

Publication of Clinical Trial Demonstrates Improved Quality of Life in Lupus Patients Using Mymee Digital Health Program

Wednesday, October 28, 2020 - 12:00pm

The study demonstrated that the Mymee Program resulted in statistically significant, clinically meaningful improvements in Health-Related Quality of Life (HRQoL) when added to usual care in patients with lupus.

Key Points: 
  • The study demonstrated that the Mymee Program resulted in statistically significant, clinically meaningful improvements in Health-Related Quality of Life (HRQoL) when added to usual care in patients with lupus.
  • The Mymee Program combines an intuitive consumer mobile app, data analytics, and certified health coaches to identify triggers for disease symptoms and modify behavior to improve health.
  • In the clinical trial, adults with lupus were assigned to either the Mymee Program plus usual care or to a control group who received usual care alone.
  • In a first for a lupus clinical trial, this study enabled 100% remote trial reporting and care delivery.

Immunovia Provides Complementary Information on the IMMray™ PanCan-d Verification and Validation Studies

Tuesday, October 27, 2020 - 3:00pm

It is standard practice to have specific inclusion criteria in place for the collection of blood samples for all diagnostic studies.

Key Points: 
  • It is standard practice to have specific inclusion criteria in place for the collection of blood samples for all diagnostic studies.
  • Immunovia has always implemented this Quality Control process of samples and has worked very closely with the clinicians to create the criteria for the Verification and Validation studies.
  • After the samples were received for the Verification study, Immunovia implemented the company's inclusion criteria.
  • This is also standard in all clinical studies and no samples were treated as outliers in the verification study.

Immunovia Provides Complementary Information on the IMMray™ PanCan-d Verification and Validation Studies

Tuesday, October 27, 2020 - 2:58pm

It is standard practice to have specific inclusion criteria in place for the collection of blood samples for all diagnostic studies.

Key Points: 
  • It is standard practice to have specific inclusion criteria in place for the collection of blood samples for all diagnostic studies.
  • Immunovia has always implemented this Quality Control process of samples and has worked very closely with the clinicians to create the criteria for the Verification and Validation studies.
  • After the samples were received for the Verification study, Immunovia implemented the company's inclusion criteria.
  • This is also standard in all clinical studies and no samples were treated as outliers in the verification study.

Immutep Announces the Start of an Investigator-Initiated Phase II Study in COVID-19 Patients

Friday, October 23, 2020 - 1:00pm

Under the Agreement, Immutep will provide efti at no cost to the University Hospital Pilsen which will fund the study.

Key Points: 
  • Under the Agreement, Immutep will provide efti at no cost to the University Hospital Pilsen which will fund the study.
  • The study will be a placebo controlled, 1:1 randomized, double blinded Phase II clinical trial involving up to 110 adult patients hospitalized with COVID-19 at University Hospital Pilsen.
  • Patients will receive subcutaneous injections of efti (10 mg) on days 1, 3 and 7, in addition to standard care.
  • Immutep CEO, Marc Voigt, said: We were delighted to be approached for this study by Dr Marek Nalos and Professor Martin Matejovic.

* * REVISED TIME * * CytoDyn to Hold Webcast on October 20 to Discuss DSMC’s Recommendations from the Interim Analysis of the Phase 2b/3 Clinical Trial for Severe-to-Critical COVID-19 Patients

Monday, October 19, 2020 - 11:32pm

Management will discuss the recommendations of the Data Safety Monitoring Committee (DSMC) following their review of the interim analysis of the first 195 patients enrolled in the Companys Phase 2b/3 clinical trial for patients with severe-to-critical COVID-19 indications, including a potential regulatory path forward.

Key Points: 
  • Management will discuss the recommendations of the Data Safety Monitoring Committee (DSMC) following their review of the interim analysis of the first 195 patients enrolled in the Companys Phase 2b/3 clinical trial for patients with severe-to-critical COVID-19 indications, including a potential regulatory path forward.
  • Management will also present slides during the webcast followed by approximately 30-45 minutes to address questions submitted online by analysts and investors.
  • This is a listen only webcast, which can be accessed via CytoDyns corporate website at www.cytodyn.com under the Investors section/IR Calendar and will be archived for 30 days.
  • Participants are encouraged to go to the website 15 minutes prior to the start of the webcast to register, download and install any necessary software.

Emapalumab's efficacy confirmed by sensitivity analysis presented at ESID2020

Saturday, October 17, 2020 - 1:33pm

"We remain committed to making emapalumab accessible to patients affected by this severe condition around the world."

Key Points: 
  • "We remain committed to making emapalumab accessible to patients affected by this severe condition around the world."
  • A high unmet medical need exists among these patients despite today's standard-of-care therapy, glucocorticoids and etoposide, with or without cyclosporine.
  • The pivotal study used clinically objective response criteria to define the primary endpoint of overall response rate to emapalumab in primary HLH.
  • The sensitivity analysis supports the use of the clinically objective ORR as a primary endpoint in studies of primary HLH.

CytoDyn to Hold Webcast on October 20 to Discuss DSMC’s Recommendations from the Interim Analysis of the Phase 2b/3 Clinical Trial for Severe-to-Critical COVID-19 Patients

Friday, October 16, 2020 - 3:59am

Management will discuss the recommendations of the Data Safety Monitoring Committee (DSMC) following their review of the interim analysis of the first 195 patients enrolled in the Companys Phase 2b/3 clinical trial for patients with severe-to-critical COVID-19 indications, including a potential regulatory path forward.

Key Points: 
  • Management will discuss the recommendations of the Data Safety Monitoring Committee (DSMC) following their review of the interim analysis of the first 195 patients enrolled in the Companys Phase 2b/3 clinical trial for patients with severe-to-critical COVID-19 indications, including a potential regulatory path forward.
  • Management will also present slides during the webcast followed by approximately 30-45 minutes to address questions submitted online by analysts and investors.
  • This is a listen only webcast, which can be accessed via CytoDyns corporate website at www.cytodyn.com under the Investors section/IR Calendar and will be archived for 30 days.
  • Participants are encouraged to go to the website 15 minutes prior to the start of the webcast to register, download and install any necessary software.