PSI Scientific Committee Webinar: Heart Failure Trials: Novel Estimands and Methodologies to Evaluate Therapies based on the Totality of Evidence
Heart failure (HF) is a common and global health problem affecting approx. 2% of adults in developed countries. Good news is that with new treatments on the market, HF has been converted from a short-term and quickly fatal condition to a chronic disease, which is characterized by recurrent non-fatal events (HF hospitalizations) and relatively low disease-related mortality. Classical heart failure trials have used a composite primary endpoint of cardiovascular (CV) death and HF hospitalization. This endpoint was then analyzed using a ‘time to first composite event’ analysis.
Various limitations of this endpoint have been raised in recent years. Among others, the ‘time to first composite event’ endpoint is thought to not fully capture the disease burden as it ignores all events that occur after the first event. Given that a number of recent large HF outcome trials have failed to show a clinical benefit for patients using the traditional endpoint, clinical teams are reviewing novel endpoints that better capture clinical benefit and which adapt to the changing disease profile.
In this session, we will discuss some of the recently proposed estimands and their associated analysis methods, ranging from composite endpoints of recurrent HF hospitalizations (HFH) and death to joint frailty models for recurrent HFH and death. We will illustrate these approaches based on various case-studies and discuss benefits as well as limitations from an academic, regulatory and industry perspective.
Application of Recurrent Events Methodology in Cardiovascular Trials
Dr. Brian Claggett (Harvard Medical School)
We describe a range of alternative models for recurrent events data collected in cardiovascular trials. We consider their applicability and interpretation from a medical context and illustrate them using data from a particular trial.
The Totality of Evidence: Is More the Same as Better?
Dr. Bruce Binkowitz (Merck)
Analysis of time to first event is a long held tradition for trials in the cardiovascular area, including heart failure. Yet subjects in these studies can experience more than 1 event. Recent literature has focused on utilizing all events experienced by each subject as a way of increasing efficiency through having to enroll less subjects, use less investigator sites, and save money. Consideration for examining all events further extends to measuring total patient burden, cost effectiveness, and most importantly, capturing the best picture of a subject's condition and therefore the best potential therapy. This presentation will discuss how analyzing total events isn't as simple as designing a traditional time to first event study and, for example, running an Anderson-Gill extension to a Cox PH model on all events. Examples will be taken from actual trials including a trial examining subjects with acute decompensated heart failure.
Recurrent or Multiple Event Analyses in Cardiovascular Trials
Dr. H.M. James Hung, US FDA
In cardiovascular or renal trials that we have seen in regulatory applications, major adverse clinical events are almost always assessed using analysis of time to first occurrence of the events. As some component events occur much more frequently, such as hospitalizations, during the trial, the analysis that includes all the events may improve statistical efficiency and capture disease burden of patients more properly. In this talk, I shall share a number of regulatory experiences with recurrent or multiple event analyses to give my insights into the possible values of such analysis and to stipulate the issues that need more attention.
Registration fee: None
This webinar is free of charge. However, attendees must register on the PSI website in order to obtain the dial-in details and the webinar link.
We do encourage your participation. If you have questions relating to this webinar, or any of the listed talks, ahead of the webinar, please email them to Mouna.Akacha@novartis.com
We will do our best to discuss them at the webinar.
PSI Scientific Committee Webinar: Heart Failure Trials: Novel Estimands and Methodologies to Evaluate Therapies based on the Totality of Evidence
Heart failure (HF) is a common and global health problem affecting approx. 2% of adults in developed countries. Good news is that with new treatments on the market, HF has been converted from a short-term and quickly fatal condition to a chronic disease, which is characterized by recurrent non-fatal events (HF hospitalizations) and relatively low disease-related mortality. Classical heart failure trials have used a composite primary endpoint of cardiovascular (CV) death and HF hospitalization. This endpoint was then analyzed using a ‘time to first composite event’ analysis.
Various limitations of this endpoint have been raised in recent years. Among others, the ‘time to first composite event’ endpoint is thought to not fully capture the disease burden as it ignores all events that occur after the first event. Given that a number of recent large HF outcome trials have failed to show a clinical benefit for patients using the traditional endpoint, clinical teams are reviewing novel endpoints that better capture clinical benefit and which adapt to the changing disease profile.
In this session, we will discuss some of the recently proposed estimands and their associated analysis methods, ranging from composite endpoints of recurrent HF hospitalizations (HFH) and death to joint frailty models for recurrent HFH and death. We will illustrate these approaches based on various case-studies and discuss benefits as well as limitations from an academic, regulatory and industry perspective.
Application of Recurrent Events Methodology in Cardiovascular Trials
Dr. Brian Claggett (Harvard Medical School)
We describe a range of alternative models for recurrent events data collected in cardiovascular trials. We consider their applicability and interpretation from a medical context and illustrate them using data from a particular trial.
The Totality of Evidence: Is More the Same as Better?
Dr. Bruce Binkowitz (Merck)
Analysis of time to first event is a long held tradition for trials in the cardiovascular area, including heart failure. Yet subjects in these studies can experience more than 1 event. Recent literature has focused on utilizing all events experienced by each subject as a way of increasing efficiency through having to enroll less subjects, use less investigator sites, and save money. Consideration for examining all events further extends to measuring total patient burden, cost effectiveness, and most importantly, capturing the best picture of a subject's condition and therefore the best potential therapy. This presentation will discuss how analyzing total events isn't as simple as designing a traditional time to first event study and, for example, running an Anderson-Gill extension to a Cox PH model on all events. Examples will be taken from actual trials including a trial examining subjects with acute decompensated heart failure.
Recurrent or Multiple Event Analyses in Cardiovascular Trials
Dr. H.M. James Hung, US FDA
In cardiovascular or renal trials that we have seen in regulatory applications, major adverse clinical events are almost always assessed using analysis of time to first occurrence of the events. As some component events occur much more frequently, such as hospitalizations, during the trial, the analysis that includes all the events may improve statistical efficiency and capture disease burden of patients more properly. In this talk, I shall share a number of regulatory experiences with recurrent or multiple event analyses to give my insights into the possible values of such analysis and to stipulate the issues that need more attention.
Registration fee: None
This webinar is free of charge. However, attendees must register on the PSI website in order to obtain the dial-in details and the webinar link.
We do encourage your participation. If you have questions relating to this webinar, or any of the listed talks, ahead of the webinar, please email them to Mouna.Akacha@novartis.com
We will do our best to discuss them at the webinar.
PSI Scientific Committee Webinar: Heart Failure Trials: Novel Estimands and Methodologies to Evaluate Therapies based on the Totality of Evidence
Heart failure (HF) is a common and global health problem affecting approx. 2% of adults in developed countries. Good news is that with new treatments on the market, HF has been converted from a short-term and quickly fatal condition to a chronic disease, which is characterized by recurrent non-fatal events (HF hospitalizations) and relatively low disease-related mortality. Classical heart failure trials have used a composite primary endpoint of cardiovascular (CV) death and HF hospitalization. This endpoint was then analyzed using a ‘time to first composite event’ analysis.
Various limitations of this endpoint have been raised in recent years. Among others, the ‘time to first composite event’ endpoint is thought to not fully capture the disease burden as it ignores all events that occur after the first event. Given that a number of recent large HF outcome trials have failed to show a clinical benefit for patients using the traditional endpoint, clinical teams are reviewing novel endpoints that better capture clinical benefit and which adapt to the changing disease profile.
In this session, we will discuss some of the recently proposed estimands and their associated analysis methods, ranging from composite endpoints of recurrent HF hospitalizations (HFH) and death to joint frailty models for recurrent HFH and death. We will illustrate these approaches based on various case-studies and discuss benefits as well as limitations from an academic, regulatory and industry perspective.
Application of Recurrent Events Methodology in Cardiovascular Trials
Dr. Brian Claggett (Harvard Medical School)
We describe a range of alternative models for recurrent events data collected in cardiovascular trials. We consider their applicability and interpretation from a medical context and illustrate them using data from a particular trial.
The Totality of Evidence: Is More the Same as Better?
Dr. Bruce Binkowitz (Merck)
Analysis of time to first event is a long held tradition for trials in the cardiovascular area, including heart failure. Yet subjects in these studies can experience more than 1 event. Recent literature has focused on utilizing all events experienced by each subject as a way of increasing efficiency through having to enroll less subjects, use less investigator sites, and save money. Consideration for examining all events further extends to measuring total patient burden, cost effectiveness, and most importantly, capturing the best picture of a subject's condition and therefore the best potential therapy. This presentation will discuss how analyzing total events isn't as simple as designing a traditional time to first event study and, for example, running an Anderson-Gill extension to a Cox PH model on all events. Examples will be taken from actual trials including a trial examining subjects with acute decompensated heart failure.
Recurrent or Multiple Event Analyses in Cardiovascular Trials
Dr. H.M. James Hung, US FDA
In cardiovascular or renal trials that we have seen in regulatory applications, major adverse clinical events are almost always assessed using analysis of time to first occurrence of the events. As some component events occur much more frequently, such as hospitalizations, during the trial, the analysis that includes all the events may improve statistical efficiency and capture disease burden of patients more properly. In this talk, I shall share a number of regulatory experiences with recurrent or multiple event analyses to give my insights into the possible values of such analysis and to stipulate the issues that need more attention.
Registration fee: None
This webinar is free of charge. However, attendees must register on the PSI website in order to obtain the dial-in details and the webinar link.
We do encourage your participation. If you have questions relating to this webinar, or any of the listed talks, ahead of the webinar, please email them to Mouna.Akacha@novartis.com
We will do our best to discuss them at the webinar.
PSI Scientific Committee Webinar: Heart Failure Trials: Novel Estimands and Methodologies to Evaluate Therapies based on the Totality of Evidence
Heart failure (HF) is a common and global health problem affecting approx. 2% of adults in developed countries. Good news is that with new treatments on the market, HF has been converted from a short-term and quickly fatal condition to a chronic disease, which is characterized by recurrent non-fatal events (HF hospitalizations) and relatively low disease-related mortality. Classical heart failure trials have used a composite primary endpoint of cardiovascular (CV) death and HF hospitalization. This endpoint was then analyzed using a ‘time to first composite event’ analysis.
Various limitations of this endpoint have been raised in recent years. Among others, the ‘time to first composite event’ endpoint is thought to not fully capture the disease burden as it ignores all events that occur after the first event. Given that a number of recent large HF outcome trials have failed to show a clinical benefit for patients using the traditional endpoint, clinical teams are reviewing novel endpoints that better capture clinical benefit and which adapt to the changing disease profile.
In this session, we will discuss some of the recently proposed estimands and their associated analysis methods, ranging from composite endpoints of recurrent HF hospitalizations (HFH) and death to joint frailty models for recurrent HFH and death. We will illustrate these approaches based on various case-studies and discuss benefits as well as limitations from an academic, regulatory and industry perspective.
Application of Recurrent Events Methodology in Cardiovascular Trials
Dr. Brian Claggett (Harvard Medical School)
We describe a range of alternative models for recurrent events data collected in cardiovascular trials. We consider their applicability and interpretation from a medical context and illustrate them using data from a particular trial.
The Totality of Evidence: Is More the Same as Better?
Dr. Bruce Binkowitz (Merck)
Analysis of time to first event is a long held tradition for trials in the cardiovascular area, including heart failure. Yet subjects in these studies can experience more than 1 event. Recent literature has focused on utilizing all events experienced by each subject as a way of increasing efficiency through having to enroll less subjects, use less investigator sites, and save money. Consideration for examining all events further extends to measuring total patient burden, cost effectiveness, and most importantly, capturing the best picture of a subject's condition and therefore the best potential therapy. This presentation will discuss how analyzing total events isn't as simple as designing a traditional time to first event study and, for example, running an Anderson-Gill extension to a Cox PH model on all events. Examples will be taken from actual trials including a trial examining subjects with acute decompensated heart failure.
Recurrent or Multiple Event Analyses in Cardiovascular Trials
Dr. H.M. James Hung, US FDA
In cardiovascular or renal trials that we have seen in regulatory applications, major adverse clinical events are almost always assessed using analysis of time to first occurrence of the events. As some component events occur much more frequently, such as hospitalizations, during the trial, the analysis that includes all the events may improve statistical efficiency and capture disease burden of patients more properly. In this talk, I shall share a number of regulatory experiences with recurrent or multiple event analyses to give my insights into the possible values of such analysis and to stipulate the issues that need more attention.
Registration fee: None
This webinar is free of charge. However, attendees must register on the PSI website in order to obtain the dial-in details and the webinar link.
We do encourage your participation. If you have questions relating to this webinar, or any of the listed talks, ahead of the webinar, please email them to Mouna.Akacha@novartis.com
We will do our best to discuss them at the webinar.
PSI Scientific Committee Webinar: Heart Failure Trials: Novel Estimands and Methodologies to Evaluate Therapies based on the Totality of Evidence
Heart failure (HF) is a common and global health problem affecting approx. 2% of adults in developed countries. Good news is that with new treatments on the market, HF has been converted from a short-term and quickly fatal condition to a chronic disease, which is characterized by recurrent non-fatal events (HF hospitalizations) and relatively low disease-related mortality. Classical heart failure trials have used a composite primary endpoint of cardiovascular (CV) death and HF hospitalization. This endpoint was then analyzed using a ‘time to first composite event’ analysis.
Various limitations of this endpoint have been raised in recent years. Among others, the ‘time to first composite event’ endpoint is thought to not fully capture the disease burden as it ignores all events that occur after the first event. Given that a number of recent large HF outcome trials have failed to show a clinical benefit for patients using the traditional endpoint, clinical teams are reviewing novel endpoints that better capture clinical benefit and which adapt to the changing disease profile.
In this session, we will discuss some of the recently proposed estimands and their associated analysis methods, ranging from composite endpoints of recurrent HF hospitalizations (HFH) and death to joint frailty models for recurrent HFH and death. We will illustrate these approaches based on various case-studies and discuss benefits as well as limitations from an academic, regulatory and industry perspective.
Application of Recurrent Events Methodology in Cardiovascular Trials
Dr. Brian Claggett (Harvard Medical School)
We describe a range of alternative models for recurrent events data collected in cardiovascular trials. We consider their applicability and interpretation from a medical context and illustrate them using data from a particular trial.
The Totality of Evidence: Is More the Same as Better?
Dr. Bruce Binkowitz (Merck)
Analysis of time to first event is a long held tradition for trials in the cardiovascular area, including heart failure. Yet subjects in these studies can experience more than 1 event. Recent literature has focused on utilizing all events experienced by each subject as a way of increasing efficiency through having to enroll less subjects, use less investigator sites, and save money. Consideration for examining all events further extends to measuring total patient burden, cost effectiveness, and most importantly, capturing the best picture of a subject's condition and therefore the best potential therapy. This presentation will discuss how analyzing total events isn't as simple as designing a traditional time to first event study and, for example, running an Anderson-Gill extension to a Cox PH model on all events. Examples will be taken from actual trials including a trial examining subjects with acute decompensated heart failure.
Recurrent or Multiple Event Analyses in Cardiovascular Trials
Dr. H.M. James Hung, US FDA
In cardiovascular or renal trials that we have seen in regulatory applications, major adverse clinical events are almost always assessed using analysis of time to first occurrence of the events. As some component events occur much more frequently, such as hospitalizations, during the trial, the analysis that includes all the events may improve statistical efficiency and capture disease burden of patients more properly. In this talk, I shall share a number of regulatory experiences with recurrent or multiple event analyses to give my insights into the possible values of such analysis and to stipulate the issues that need more attention.
Registration fee: None
This webinar is free of charge. However, attendees must register on the PSI website in order to obtain the dial-in details and the webinar link.
We do encourage your participation. If you have questions relating to this webinar, or any of the listed talks, ahead of the webinar, please email them to Mouna.Akacha@novartis.com
We will do our best to discuss them at the webinar.
PSI Scientific Committee Webinar: Heart Failure Trials: Novel Estimands and Methodologies to Evaluate Therapies based on the Totality of Evidence
Heart failure (HF) is a common and global health problem affecting approx. 2% of adults in developed countries. Good news is that with new treatments on the market, HF has been converted from a short-term and quickly fatal condition to a chronic disease, which is characterized by recurrent non-fatal events (HF hospitalizations) and relatively low disease-related mortality. Classical heart failure trials have used a composite primary endpoint of cardiovascular (CV) death and HF hospitalization. This endpoint was then analyzed using a ‘time to first composite event’ analysis.
Various limitations of this endpoint have been raised in recent years. Among others, the ‘time to first composite event’ endpoint is thought to not fully capture the disease burden as it ignores all events that occur after the first event. Given that a number of recent large HF outcome trials have failed to show a clinical benefit for patients using the traditional endpoint, clinical teams are reviewing novel endpoints that better capture clinical benefit and which adapt to the changing disease profile.
In this session, we will discuss some of the recently proposed estimands and their associated analysis methods, ranging from composite endpoints of recurrent HF hospitalizations (HFH) and death to joint frailty models for recurrent HFH and death. We will illustrate these approaches based on various case-studies and discuss benefits as well as limitations from an academic, regulatory and industry perspective.
Application of Recurrent Events Methodology in Cardiovascular Trials
Dr. Brian Claggett (Harvard Medical School)
We describe a range of alternative models for recurrent events data collected in cardiovascular trials. We consider their applicability and interpretation from a medical context and illustrate them using data from a particular trial.
The Totality of Evidence: Is More the Same as Better?
Dr. Bruce Binkowitz (Merck)
Analysis of time to first event is a long held tradition for trials in the cardiovascular area, including heart failure. Yet subjects in these studies can experience more than 1 event. Recent literature has focused on utilizing all events experienced by each subject as a way of increasing efficiency through having to enroll less subjects, use less investigator sites, and save money. Consideration for examining all events further extends to measuring total patient burden, cost effectiveness, and most importantly, capturing the best picture of a subject's condition and therefore the best potential therapy. This presentation will discuss how analyzing total events isn't as simple as designing a traditional time to first event study and, for example, running an Anderson-Gill extension to a Cox PH model on all events. Examples will be taken from actual trials including a trial examining subjects with acute decompensated heart failure.
Recurrent or Multiple Event Analyses in Cardiovascular Trials
Dr. H.M. James Hung, US FDA
In cardiovascular or renal trials that we have seen in regulatory applications, major adverse clinical events are almost always assessed using analysis of time to first occurrence of the events. As some component events occur much more frequently, such as hospitalizations, during the trial, the analysis that includes all the events may improve statistical efficiency and capture disease burden of patients more properly. In this talk, I shall share a number of regulatory experiences with recurrent or multiple event analyses to give my insights into the possible values of such analysis and to stipulate the issues that need more attention.
Registration fee: None
This webinar is free of charge. However, attendees must register on the PSI website in order to obtain the dial-in details and the webinar link.
We do encourage your participation. If you have questions relating to this webinar, or any of the listed talks, ahead of the webinar, please email them to Mouna.Akacha@novartis.com
We will do our best to discuss them at the webinar.
An introductory course giving an overview of the pharmaceutical industry and the drug development process as a whole, aimed at those with 1-3 years' experience. It comprises of six 2-day sessions covering a range of topics including Research and Development, Toxicology, Data Management and the Role of a CRO, Clinical Trials, Reimbursement, and Marketing.
Our monthly webinar explores examples of innovative data visualisations relevant to our day to day work. Each month a new dataset is provided from a clinical trial or other relevant example, and participants are invited to submit a graphic that communicates interesting and relevant characteristics of the data.
Who is this event intended for? Statisticians with an interest understanding dose-finding in oncology. What is the benefit of attending? Learn about the state of oncology dose finding, particularly in light of current FDA guidance.
The book club’s usual focus is to read and discuss professional development books. In this short format event you can more easily develop you career without the commitment of reading the whole book - simply listen to the 1-hour long podcast before joining the interactive session on 21 May.
This webinar is organised by the RWD SIG and the Historical Data SIG. We will review recent methods, applications, and tools of integrating subject-level-data from clinical trial with external data using Bayesian methods and/or causal inference methods.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
This course is aimed at biostatisticians with no or some pediatric drug development experience who are interested to further their understanding. We will give you an introduction to the pediatric drug development landscape. This will include identifying the key regulations and processes governing pediatric development, a discussion on the needs and challenges when conducting pediatric research and a focus on the ways to overcome these challenges from a statistical perspective.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
The Institute of Cancer Research are seeking to appoint a Research Group Leader to join The CRUK Clinical Trials and Statistics Unit at the ICR.
This is an exciting, new opportunity for an experienced Statistician looking to take the next step in their career. Offered as a remote or hybrid position aligned with our site in Harrogate, North Yorkshire.
The BioMarin internship programme will enable students to gain valuable experience and knowledge of the processes and systems within BioMarin, whilst gaining an insight into the pharmaceutical/biotech industry.
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