Illustrating uncertainty in extrapolating evidence for cost-effectiveness mod...cheweb1
Illustrating uncertainty in extrapolating evidence for cost-effectiveness modelling, economic evaluation seminar, given by Dr Laura Bojke, Centre for Health Economics, University of York. 16 June 2016
University of Liverpool Researcher KnowHow session presented by John Tyson-Carr, covering:
1. The Average Publication Process.
2. The Reproducibility Crisis
3. What is a Registered Report?
4. Why Registered Reports?
5. An Example.
6. Misconceptions, Tips and Career Implications
modern management technique tells us about the management techniques and its implication in health field.
From Statistical methods to SWOT analysis is explained with example.
It also tells about log frame and cost benefit and cost effective analysis
Designing studies with recurrent events | Model choices, pitfalls and group s...nQuery
In this free webinar, we will examine the important design considerations for analyzing recurring events and counts.
Watch the webinar at: https://www.statsols.com/en/webinar/designing-studies-with-recurrent-events
Designing studies with recurrent events (Model choices, pitfalls and group sequential design)
2020 trends in biostatistics what you should know about study design - slid...nQuery
2020 Trends In Biostatistics - What you should know about study design.
In this free webinar you will learn about:
-Adaptive designs in confirmatory trials
-Using external data in study planning
-Innovative designs in early-stage trials
To watch the full webinar:
https://www.statsols.com/webinar/2020-trends-in-biostatistics-what-you-should-know-about-study-design
Sample size for survival analysis - a guide to planning successful clinical t...nQuery
Determining the appropriate number of events needed for survival analysis is a complex task as study planners try to predict what sample size will be needed after accounting for the complications of unequal follow-up, drop-out and treatment crossover.
The statistical, logistical and ethical considerations all complicate life for biostatisticians as issues to balance in planning a survival analysis. However, this complexity has created a need for new analyses and procedures to help the planning process for survival analysis trials.
The wider move from fixed to flexible designs has opened up opportunities for advanced methods such as adaptive design and Bayesian analysis to help deal with the unique complications of planning for survival data but these methods have their own complications that need to be explored too.
Illustrating uncertainty in extrapolating evidence for cost-effectiveness mod...cheweb1
Illustrating uncertainty in extrapolating evidence for cost-effectiveness modelling, economic evaluation seminar, given by Dr Laura Bojke, Centre for Health Economics, University of York. 16 June 2016
University of Liverpool Researcher KnowHow session presented by John Tyson-Carr, covering:
1. The Average Publication Process.
2. The Reproducibility Crisis
3. What is a Registered Report?
4. Why Registered Reports?
5. An Example.
6. Misconceptions, Tips and Career Implications
modern management technique tells us about the management techniques and its implication in health field.
From Statistical methods to SWOT analysis is explained with example.
It also tells about log frame and cost benefit and cost effective analysis
Designing studies with recurrent events | Model choices, pitfalls and group s...nQuery
In this free webinar, we will examine the important design considerations for analyzing recurring events and counts.
Watch the webinar at: https://www.statsols.com/en/webinar/designing-studies-with-recurrent-events
Designing studies with recurrent events (Model choices, pitfalls and group sequential design)
2020 trends in biostatistics what you should know about study design - slid...nQuery
2020 Trends In Biostatistics - What you should know about study design.
In this free webinar you will learn about:
-Adaptive designs in confirmatory trials
-Using external data in study planning
-Innovative designs in early-stage trials
To watch the full webinar:
https://www.statsols.com/webinar/2020-trends-in-biostatistics-what-you-should-know-about-study-design
Sample size for survival analysis - a guide to planning successful clinical t...nQuery
Determining the appropriate number of events needed for survival analysis is a complex task as study planners try to predict what sample size will be needed after accounting for the complications of unequal follow-up, drop-out and treatment crossover.
The statistical, logistical and ethical considerations all complicate life for biostatisticians as issues to balance in planning a survival analysis. However, this complexity has created a need for new analyses and procedures to help the planning process for survival analysis trials.
The wider move from fixed to flexible designs has opened up opportunities for advanced methods such as adaptive design and Bayesian analysis to help deal with the unique complications of planning for survival data but these methods have their own complications that need to be explored too.
Sample size calculation in medical researchKannan Iyanar
A short description on estimation of sample size in health care research. It describes the basic concepts in sample size estimation and various important formulae used for it.
A practical guide to do primary research on meta analysis methodology - PubricaPubrica
• Conventional meta-analysis research techniques are extended to accommodate methods and practices found in basic research.
• Apart from clinical research, where consolidation efforts are facilitated by systematic review and meta-analysis research, basic science occasionally use such rigorous quantitative methods.
Reference: http://bit.ly/2N2iVg8
Continue Reading: https://pubrica.com/services/research-services/meta-analysis/
Why Pubrica?
When you order our services, Plagiarism free|onTime|outstanding customer support|Unlimited Revisions support|High-quality Subject Matter Experts.
Contact us :
Web: https://pubrica.com/
Blog: https://pubrica.com/academy/
Email: sales@pubrica.com
WhatsApp : +91 9884350006
United Kingdom: +44- 74248 10299
Non-inferiority and Equivalence Study design considerations and sample sizenQuery
About the webinar
This webinar examines the role of non-inferiority and equivalence in study design
In this free webinar, you will learn about:
-Regulatory information on this type of study design
-Considerations for study design and your sample size
-Practical worked examples of
--Non-inferiority Testing
--Equivalence Testing
Duration - 60 minutes
Speaker: Ronan Fitzpatrick, Head of Statistics, Statsols
Watch the video at: https://www.statsols.com/webinars
Big data vs the RCT - Derek Angus - SSAI2017scanFOAM
A talk by Derek Angus at the 2017 meeting of the Scandinavian Society of Anaestesiology and Intensive Care Medicine.
All of the conference content can be found here: https://scanfoam.org/ssai2017/
Developed in collaboration between scanFOAM, SSAI and SFAI.
Defining a Central Monitoring Capability: Sharing the Experience of TransCele...www.datatrak.com
Central monitoring, on-site monitoring, and off-site monitoring provide an integrated approach to clinical trial quality management. TransCelerate distinguishes central monitoring from other types of central data review activities and puts it in the context of an overall monitoring strategy. Any organization seeking to implement central monitoring will need people with the right skills, technology options that support a holistic review of study-related information, and adaptable processes. There are different approaches actively being used to implement central monitoring. This article provides a description of how companies are deploying central monitoring, as well as samples of the workflows that illustrate how some have implemented it. The desired outcomes include earlier, more predictive detection of quality issues. This paper describes the initial implementation steps designed to learn what organizational capabilities are necessary.
Innovative Strategies For Successful Trial Design - Webinar SlidesnQuery
Full webinar available here: https://www.statsols.com/webinar/innovative-strategies-for-successful-trial-design
[Webinar] Innovative Strategies For Successful Trial Design- In this free webinar, you will learn about:
- The challenges facing your trials
- How to calculate the correct sample size
- Worked examples including Mixed/Hierarchical Models
- Posterior Error
- Adaptive Designs For Survival
www.statsols.com
Group project
Population : The elderly
Communicator: Sidney
Topic: Injury prone (Nursing home, diseases, trauma, statistics
Title: Fall and Injury Prevent for the Elderly patients
Set age group: 60-75
Gender: Both male and female
Ethnicity: will briefly discuss how other ethnicities are correlates with this data
Goals and Objectives:
Reduce injuries in nursing homes
Educational programs for employers
Know signs and symptoms for serious trauma minor or huge
Documentation that prevention is key (objective)
Set specific needs for elderly, identify program focus
Come up with time line for statistics
Source: chapter 10 fall and injury prevention
Needs:
Set more goals and objectives
Data
Basis of what We want to do for our program
What moto will we use?
Program Ideas:
Offer a class over prevention
Send trained professional to admit training
Inform patients on a way to prevent falling
Certification of test after class
Proper equipment (gate belts, lifts, rails, and walkers)
Conduct survey than evaluate the results
Signs indicating reminders of safety tips
Cautious of prescribed medicines and,diets that they have
Assess patient risk
Implementation:
*precede procedure method
Precede: help with measurable objectives for projects
Proceed- monitor quality of methods to keep program going
Overview- program cost X amount
Whats 1st?
Send trained professional
Educate the workers + certifications
Assess patient needs
Inform patients over information
Assess what equipment is needed
Safety tips are posted
Look at increase + decrease of falls (stats)
Survey the effectiveness of programs
Go in depth of how survey results affect the program and ETC
Survey should go to nursing home administrator
Make a short survey
Part 1.Program assessment- someone (
Two Slides of power point)
Part 2.Planning- someone (
Two Slides of power point)
Part 3.Goals and objectives- someone (
Two Slides of power point)
Part 4.Development and implementation- someone (
Two Slides of power point)
Part 5.Evaluating the results- Me :
( One page , One source And Two Slides of power point)
YOU HAVE to Take Care of THIS PART
(
Evaluating the results)
And Than do Power Point for all Group project 10 Slides 2 Slides for each Part
***Evaluating the results- Me :
( One page , One source And Two Slides of power point)
.
Clinical Research Statistics for Non-StatisticiansBrook White, PMP
Through real-world examples, this presentation teaches strategies for choosing appropriate outcome measures, methods for analysis and randomization, and sample sizes as well as tips for collecting the right data to answer your scientific questions.
Sample size calculation in medical researchKannan Iyanar
A short description on estimation of sample size in health care research. It describes the basic concepts in sample size estimation and various important formulae used for it.
A practical guide to do primary research on meta analysis methodology - PubricaPubrica
• Conventional meta-analysis research techniques are extended to accommodate methods and practices found in basic research.
• Apart from clinical research, where consolidation efforts are facilitated by systematic review and meta-analysis research, basic science occasionally use such rigorous quantitative methods.
Reference: http://bit.ly/2N2iVg8
Continue Reading: https://pubrica.com/services/research-services/meta-analysis/
Why Pubrica?
When you order our services, Plagiarism free|onTime|outstanding customer support|Unlimited Revisions support|High-quality Subject Matter Experts.
Contact us :
Web: https://pubrica.com/
Blog: https://pubrica.com/academy/
Email: sales@pubrica.com
WhatsApp : +91 9884350006
United Kingdom: +44- 74248 10299
Non-inferiority and Equivalence Study design considerations and sample sizenQuery
About the webinar
This webinar examines the role of non-inferiority and equivalence in study design
In this free webinar, you will learn about:
-Regulatory information on this type of study design
-Considerations for study design and your sample size
-Practical worked examples of
--Non-inferiority Testing
--Equivalence Testing
Duration - 60 minutes
Speaker: Ronan Fitzpatrick, Head of Statistics, Statsols
Watch the video at: https://www.statsols.com/webinars
Big data vs the RCT - Derek Angus - SSAI2017scanFOAM
A talk by Derek Angus at the 2017 meeting of the Scandinavian Society of Anaestesiology and Intensive Care Medicine.
All of the conference content can be found here: https://scanfoam.org/ssai2017/
Developed in collaboration between scanFOAM, SSAI and SFAI.
Defining a Central Monitoring Capability: Sharing the Experience of TransCele...www.datatrak.com
Central monitoring, on-site monitoring, and off-site monitoring provide an integrated approach to clinical trial quality management. TransCelerate distinguishes central monitoring from other types of central data review activities and puts it in the context of an overall monitoring strategy. Any organization seeking to implement central monitoring will need people with the right skills, technology options that support a holistic review of study-related information, and adaptable processes. There are different approaches actively being used to implement central monitoring. This article provides a description of how companies are deploying central monitoring, as well as samples of the workflows that illustrate how some have implemented it. The desired outcomes include earlier, more predictive detection of quality issues. This paper describes the initial implementation steps designed to learn what organizational capabilities are necessary.
Innovative Strategies For Successful Trial Design - Webinar SlidesnQuery
Full webinar available here: https://www.statsols.com/webinar/innovative-strategies-for-successful-trial-design
[Webinar] Innovative Strategies For Successful Trial Design- In this free webinar, you will learn about:
- The challenges facing your trials
- How to calculate the correct sample size
- Worked examples including Mixed/Hierarchical Models
- Posterior Error
- Adaptive Designs For Survival
www.statsols.com
Group project
Population : The elderly
Communicator: Sidney
Topic: Injury prone (Nursing home, diseases, trauma, statistics
Title: Fall and Injury Prevent for the Elderly patients
Set age group: 60-75
Gender: Both male and female
Ethnicity: will briefly discuss how other ethnicities are correlates with this data
Goals and Objectives:
Reduce injuries in nursing homes
Educational programs for employers
Know signs and symptoms for serious trauma minor or huge
Documentation that prevention is key (objective)
Set specific needs for elderly, identify program focus
Come up with time line for statistics
Source: chapter 10 fall and injury prevention
Needs:
Set more goals and objectives
Data
Basis of what We want to do for our program
What moto will we use?
Program Ideas:
Offer a class over prevention
Send trained professional to admit training
Inform patients on a way to prevent falling
Certification of test after class
Proper equipment (gate belts, lifts, rails, and walkers)
Conduct survey than evaluate the results
Signs indicating reminders of safety tips
Cautious of prescribed medicines and,diets that they have
Assess patient risk
Implementation:
*precede procedure method
Precede: help with measurable objectives for projects
Proceed- monitor quality of methods to keep program going
Overview- program cost X amount
Whats 1st?
Send trained professional
Educate the workers + certifications
Assess patient needs
Inform patients over information
Assess what equipment is needed
Safety tips are posted
Look at increase + decrease of falls (stats)
Survey the effectiveness of programs
Go in depth of how survey results affect the program and ETC
Survey should go to nursing home administrator
Make a short survey
Part 1.Program assessment- someone (
Two Slides of power point)
Part 2.Planning- someone (
Two Slides of power point)
Part 3.Goals and objectives- someone (
Two Slides of power point)
Part 4.Development and implementation- someone (
Two Slides of power point)
Part 5.Evaluating the results- Me :
( One page , One source And Two Slides of power point)
YOU HAVE to Take Care of THIS PART
(
Evaluating the results)
And Than do Power Point for all Group project 10 Slides 2 Slides for each Part
***Evaluating the results- Me :
( One page , One source And Two Slides of power point)
.
Clinical Research Statistics for Non-StatisticiansBrook White, PMP
Through real-world examples, this presentation teaches strategies for choosing appropriate outcome measures, methods for analysis and randomization, and sample sizes as well as tips for collecting the right data to answer your scientific questions.
Presentation on the examination of microbiological data for assessment and trending.
Includes: normalizing data, graphs, and assessment of alert and action levels.
Certified Specialist Business Intelligence (.docxdurantheseldine
Certified Specialist Business
Intelligence (CSBI) Reflection
Part 5 of 6
CSBI Course 5: Business Intelligence and Analytical and Quantitative Skills
● Thinking about the Basics
● The Basic Elements of Experimental Design
● Sampling
● Common Mistakes in Analysis
● Opportunities and Problems to Solve
● The Low Severity Level ED (SL5P) Case Setup as an Example of BI Work
● Meaningful Analytic Structures
Analysis and Statistics
A key aspect of the work of the BI/Analytics consultant is analysis. Analysis can be defined as
how the data is turned into information. Information is the outcome when the data is analyzed
correctly.
Rigorous analysis is having the best chance of creating the sharpest picture of what the data
might reveal and is the product of proper application of statistics and experimental design.
Statistics encompasses a complex and detailed series of disciplines. Statistical concepts are
foundational to all descriptive, predictive and prescriptive analytic applications. However, the
application of simple descriptive statistical calculations yields a great deal of usable information
for transformational decision-making. The value of the information is amplified when using these
same simple statistics within the context of a well-designed experiment.
This module is not designed to teach one statistic. It is designed to place statistical work within
the appropriate context so that it can be leveraged most effectively in driving organizational
performance..
An important review of the basic knowledge for work with descriptive and inferential statistics.
The Basic Elements of Experimental Design
Analytic tools also can provide an enhanced ability to conduct experiments. More than just
allowing analysis of output of activities or processes, experiments can be performed on
processes and the output of processes. Experimenting on processes is a movement beyond
the traditional r.
The Role and Responsibilities of Statisticians in Clinical Trials Presentation to MedicReS 5th World Congress on October 19-25,2015 in New York by Shing Lee, PhD
This is a study case in all the photosthe SIPOC diagram bel.pdfjkcs20004
This is a study case in all the photos
the SIPOC diagram bellow is incomplete and wrong I need to fix it
Perfect Match TEAM APPLIES n January 2008, the University of Toledo Medical Center
(UTMC) in northwest Ohio collaborated with the University of Toledo's Industrial SIX SIGMA
TO Engineering Department to analyze and improve the preoperational processes for patients
undergoing kidney transplants. Six Sigma was applied to the REDUCE TIME project, and the
following goals were established: IT TAKES TO - Optimize cycle times. QUALIFY PATIENTS
- Enhance customer satisfaction. - Improve efficiencies. FOR KIDNEY - Reduce costs.
TRANSPLANTS - Streamline administrative processes. - Eliminate errors. - Improve protocol
execution and effectiveness. The project's primary metric was the number of days required from
the date a patient was referred to UTMC for a kidney transplant to the date the hospital staff
declared the patient a suitable transplant candidate. The research By Matthew was needed and
the project selected because of an increase in the number of Franchetti and year because of the
increased service area for UTMC. Because of a waiting list of nearly 500 patients, it was
determined a reduced cycle time would save lives. Kyle Bedal, Background and terminology
University of For more than 30 years, UTMC has performed adult and pediatric kidney Toledo
transplants as one of the treatment options for end-stage renal disease. Since UTMC's first
kidney transplant operation in 1972, more than 1,500 kidney transplant operations have been
performed there, with an average patient survival rate of 98% and a graft survival rate of 94%.
The program relies on advanced surgical techniques-including laparoscopic kidney donation,
improved anti-rejection medications and high-quality patient care-to make it one of the most
successful programs in the country. There are a number of steps patients must complete before
receiving a kidney transplant. Generally, the patient must be referred to a medical center and
complete required labs and tests to determine if he or she is suitable. The labs and tests are
usually similar among all transplant centers and among patients. The labs include tuberculosis
(TB) tests, dental clearance, a colonoscopy, chest X-rays, electrocardiography tests, stool
samples, blood work, mammograms, pap smears and diabetes tests. Once the patient fulfills the
requirements, a committee reviews the results and determines whether the patient is a good
candidate. The patient is then allowed to receive a kidney; this is called being "listed," or placed
on the waiting list.
Fil TB EK Often, the time required to complete these health Partnering With Your Transplant
Team, The Patient's Guide screenings is up to nine months. In addition, another to
Transplantation. 2 two years may pass after the patient is listed before a The team deployed the
define, measure, analyze, kidney transplant is performed. improve and control (DMAIC)
approach for this Six It is.
Data Con LA 2019 - Best Practices for Prototyping Machine Learning Models for...Data Con LA
Medical institutions, universities and software giants like Google and Microsoft are dedicating increasing resources to machine learning for healthcare. This is a very exciting but relatively young field. However, best practices for methods and reporting of results are not yet fully established. I have 2.5 years of experience as data scientist at a national cancer center working on clinical data, evaluating external vendors and peer reviewing machine learning in healthcare papers. The talk gives an overview of best practices in prototyping machine learning models on data from the patient electronic health record (EHR). The topics addressed are:1. Introduction to the EHR2. Overview of machine learning applications to the EHR3. Cohort definition for survival problems4. Data cleaning5. Performance metricsExcerpts of papers from renowned institutions will be critically reviewed. The material is intended to be useful not only to machine learning for healthcare professionals, but to practitioners dealing with very unbalanced dataset in the temporal domain. For example, customer churn prediction can be modeled as survival problem.
The use of Adaptive designs is becoming quite popular and well-perceived by the regulatory agencies such as the FDA in the US. “Adaptation” can occur in different fashion and potentially make studies more efficient (e.g. shorter duration, fewer patients) more likely to demonstrate an effect of the drug if one exists, or more informative (see “Adaptive Design Clinical Trials for Drugs and Biologics” FDA guidance).
The aim of this presentation is to illustrate a case where an adaptive design was used in a Phase III oncology pivotal study having Overall Survival as a primary end-point. The particular adaptation implemented was an un-blinded SSR that applied a promising zone approach.
The main focus will be how the adaptive design impacted the SDTM modelling, the design of some ADaM datasets (e.g. those containing the time-to-event endpoints and therefore using ADTTE ADaM model) and later on how some mapping and analysis decisions were described in both the study and analysis reviewer guide.
Protocol Design & Development: What You Need to Know to Ensure a Successful S...Brook White, PMP
Solid protocol design is critical to clinical development. No matter how well executed a clinical study is, if the underlying design is flawed, it wasn’t worth doing. In this presentation, Dr. David Shoemaker, SVP R&D, and Dr. Karen Kesler, AVP Operations, will walk through the process of developing a protocol, explain the major considerations, and point out common mistakes and challenges.
Similar to 2012-05-30 EUGM | GAYDOS | Design & Analysis Approaches to Evaluate Cardiovascular Risk (20)
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
1. Cytel East Users Group Meeting
Cambridge, Massachusetts
D i d A l i A h
Cambridge, Massachusetts
Design and Analysis Approaches
to Evaluate Cardiovascular Risk
October 12, 2012
11:45-12:15
Brenda Gaydos, Ph.D. Research Fellow
3. Background
• CV disease remains the leading cause of morbidity and mortality in patients
with diabetes
• In light of the potentially harmful CV effects raised with rosiglitazone,
regulatory agencies now require Sponsors to show that a new therapy for
T2DM is not associated with an unacceptable increase in CV risk
Primary
– Hazard Ratio (HR)
– Time to first occurrence of any of the following adjudicated components:
• MACE (or 3-point MACE): CV death, non-fatal MI, non-fatal stroke
• MACE +: typically 4th component hospitalization for unstable angina
– Cox proportional hazards model
– Non-inferiority to standard of care
– ITT population
3
4. FDA guidance: CI for CV Meta AnalysisFDA guidance: CI for CV Meta-Analysis
Upper bound of a 2-Upper bound of a 2
sided 95% CI for
estimated CV risk Ratio
Conclusion
>1.8
Data are inadequate to support approval.
A large safety trial should be conducted
The potential for CV harm may still exist.
1.3 – 1.8* An adequately powered and designed post-marketing trial
is needed to show an upper bound < 1.3
<1.3* Post-marketing CV trial is generally not needed3 g g y
*with a reassuring point estimate
CI = confidence interval
42008 FDA Guidance for Industry: Diabetes Mellitus – Evaluating CV risk in new antidiabetic
therapies to treat type 2 diabetes. www.fda.gov
5. Cardiac Safety Research Consortium
White Paper
Working title Designs and statistical approaches to assess CV• Working title: Designs and statistical approaches to assess CV
risk of new type 2 diabetes therapies in development
• Target journal: American Heart Journal
Objectives
• Increase the quality and efficiency of CV risk assessment of new
therapies to treat T2DMtherapies to treat T2DM
• Propose study designs and statistical analysis methods to meet
current CV safety regulatory requirements
• Discuss operational considerations (e g processes for interim• Discuss operational considerations (e.g. processes for interim
analyses)
• Use simulation to provide examples and discuss impact of
decisionsdecisions
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6. Typical Development Program
Efficacy Studies
– 3-5 Phase 3 studies (HbA1c is primary)
– 1-2 Phase 2 studies1 2 Phase 2 studies
Discharge 1.8 and 1.3 based on meta-analysis
– Independent, blinded, adjudication of all CV events
– Prospectively planned meta-analysis at end of phase 3
– Sufficient events to allow a meaningful estimate of risk
– Include patients at higher risk of CV events (e.g. relatively advanced
disease elderly patients some degree of renal impairment)disease, elderly patients, some degree of renal impairment)
– Controlled trials of longer duration needed (minimum 2 years)
Challengesg
– Few events
– Typically lower risk population
– Relatively short duration
– Can meet statistical significance, but be inconsistent across sensitivity
analyses
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7. No Dedicated CV Trial: Challenging
Assume:
– All trials start in parallel; Fixed duration follow-up
1 year to fully enroll a trial; 1% lost to follow up– 1 year to fully enroll a trial; 1% lost to follow-up
– 90% power for non-inferiority (1.3)
True HR Fixed Sample Size Sample Size
Duration (2% event rate
on control)
(1% event rate
on control)
0.80
(178 events)
18 months 10,058 20,017
(178 events)
2 years 6,750 13,405
3 years 4,106 8,118
1
(611 events)
18 months 31,028 61,722
2 years 20 831 41 342
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2 years 20,831 41,342
3 years 12,681 25,047
8. Some Challenges Initiating a CV Study
Initiate during phase 3 development
– Benefit: Insure timely discharge of 1.8
– Need CV study prior to knowing dose/effect
– If continue the CV study, need to maintain appropriate blind for interim
– True HR unknown (assume equivalent for powering)True HR unknown (assume equivalent for powering)
– Rate of events unknown (over/under estimate N needed to maintain
acceptable duration)
Initiate after phase 3 development
– Risk not meeting 1.8
Same uncertainty in unknown HR and rate of events– Same uncertainty in unknown HR and rate of events
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9. Statistical Methods
Setting
• Desirable to initiate a CV study in phase 3 development
• Desirable to leverage accruing information to mitigate risk in the
presence of so much uncertainty
• Focus on methods that are well understoodFocus on methods that are well understood
MethodsMethods
– Meta-analysis
– Group Sequential Designs
R ti ti # t– Re-estimating #events
– Sample-size re-estimation
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10. Statistical Methods
Meta-Analysis: Reduce patient exposure by efficiently utilizing events
– Acceptable for 1.8 (phase 2,3 & possibly CV trial)p (p , p y )
– Acceptable for 1.3 (CV trials & possibly phase 2,3 trials)
– ? Acceptable for 1 (CV trials)
• Does superiority need to be demonstrate in a single CV Outcomes trial?• Does superiority need to be demonstrate in a single CV Outcomes trial?
• Typically seeing gated hypothesis testing within meta-analysis: 1st test HR <
1.3, then test HR < 1
• If an interim analysis is utilized for assessing 1.8:
– Need acceptable process to maintain blind of ongoing studies
– Completely blind the sponsor (CRO or some other body)
– Blind the study team, but not the sponsor (e.g. team internal to sponsor, but
firewalled from study team; internal steering committee with CRO)
• What will be published in SBA? [Transparency / Data Confidentiality]
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11. Statistical Methods
Group Sequential Designs: Opportunity to stop early for success
(1.8, 1.3 or 1)(1.8, 1.3 or 1)
– Opportunity to answer the question sooner & reduce patient exposure
– Can be combined with meta-analysis to further reduce patient exposure
• Determine in advance the maximum number of events and alphaDetermine in advance the maximum number of events, and alpha
spend
– Allows for multiple interims to avoid looking too early or too late
– Need to establish minimum clinically meaningful exposure (notNeed to establish minimum clinically meaningful exposure (not
just about statistical significance on MACE)
Current recommendations:
Encouraging of group sequential designs
Determine a-priori alpha spend and number of events at each analysis
Alpha spend is sponsor’s choice (preference for O’Brien-Fleming)p p p (p g)
Report adjusted point estimator
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12. Group Sequential Design (GSD) Approaches
Assume single CV study to demonstrate HR <1.3, non-inferiority
– O’Brien-Fleming spending function, 3 look design for early stopping, 90% power
– Fixed design requires 611 events if true HR = 1
True HR Average # Events
(400, 513, 626)
Average # Events
(500, 565, 629)
1.00 480 527
0.90 418 503
0.85 406 501
0.80 401 500
0.75 400 500
Design Pr Stop at Interim 1 Pr Stop By Interim 2 Pr Success By
Final Analysis
400, 513, 626 0.52 0.767 0.90
If the true HR is 1
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500, 565, 629 0.75 0.838 0.90
13. Statistical Methods
Sample-size re-estimation (Duration): Right-size the study
– Sample-size drives study duration, NOT powerp y , p
– Opportunity to increase sample size if needed to maintain reasonable
study duration once more information is gathered on event rate
Analysis can be done using blinded data (observed event rate)– Analysis can be done using blinded data (observed event rate)
Re-estimating # Events (Power): Minimize patient years
– # events drive power– # events drive power
– Delay upfront investment to power for superiority given initial uncertainty
in true HR
Si i iti ll f i f i it ith th ti t i # t if– Size initially for non-inferiority with the option to increase # events if
superiority is likely (e.g. utilize estimate of HR at ~400 events)
– Analysis likely will require unblinded data
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14. Click to edit Master title style
DEVELOPMENT OPTIONS
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15. Single CV Trial: Approaches
A. Fixed Design: Assessing 1.3 only (or 1)
• 1.8 assessed only from phase 2 & 3 via meta-analysisy p y
Pro: No interim analysis needed
Con: Cannot be used to discharge 1.8 if insufficient events observed (even
if initiated prior to end of phase 3)
To utilize the CV trial as back-up to discharge 1.8
Group Sequential Design approach would be needed (alpha• Group Sequential Design approach would be needed (alpha
spending 1.8)
• Needs to be pre-specified in meta-analysis plan PRIOR to
unblinding Phase 3unblinding Phase 3
• CV Trial needs to incorporate an interim analysis based on timing
relative to the total #events needed for the meta-analysis
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16. Single CV Trial: Approaches
B. GSD: Assessing both 1.8 and 1.3 (or 1)
• Must start prior to completion of Phase 3
• Incorporating separate alpha spending for 1.8 & 1.3
• May incorporate GSD for 1.8 and/or 1.3 for early stopping
• May also incorporate meta-analysis for 1.8
• Can incorporate blinded SSR on observed event rate to manage duration
Pre Submission
Period
Post Submission Period
Can incorporate blinded SSR on observed event rate to manage duration
Period
Group Sequential Design
Increase likelihood of meeting 1.8 as soon as Phase 3 trials complete
Group Sequential Designg p
Increase likelihood of meeting 1.8 without requiring additional study
Group Sequential Design
Possibility to stop earlier if objectives meet
Blinded SSR
to manage duration
Meta-Analysis
Event from Phase 2 & 3
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17. Single CV Trial: Approaches
Group Sequential Design (at 400
events) Enable Early Stopping for
Superiority Only ( < 0.001)
C. Plan for non-inferiority with option to enlarge
study to demonstrate superiority (example)
Event Re-estimation (at 400 events)
Assess the Likelihood of Superiority,
Increase the #Events if superiority likely
Sample Size Re-estimation
Manage Post Submission Trial Duration
8000 (max of 9622)
Pre Submission
Period
Post Submission Period
Final Analysis
(750 or 1067
events)
Impact vs Superiority Design (N=9622, #Events 1067)
Approximately same power for superiorityGroup Sequential Design with Meta- pp y p p y
Earlier Submission: 3 months
Reduced Cost: (20%) 40M-50M
Reduced Trial Duration:
1 year if superiority is true
p q g
Analysis to discharge 1.8
100 & 130 events, Pocock spending
function, min 90% power (versus 122
single analysis)
6 months if non-inferiority is true
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18. Operating Characteristics
Across Range of HRsFixed
Approximately the
same power for
superiority
Adaptive
p y
Adaptive design
reduces the number of
patient years
KEY
Lines: Power (scale on left)
Bars: Patient Yrs (scale on right)
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19. Two CV Trials
Objective:
Non inferiority– Non-inferiority
– Meta-analysis approach to discharge 1.8 & 1.3
• 1.8: 1st CV study and Phase 2 & 3y
• 1.3: 2 CV studies only
Benefits:
– Flexibility to adjust to learning
– Stop or continue 1st CV study depending on results of Phase 3
Utilize design of 2nd CV study to add or remove doses if needed– Utilize design of 2nd CV study to add or remove doses if needed
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20. Two CV Trials: Example
Design Outline
1st CV st d starts in parallel ith phase 31st CV study starts in parallel with phase 3
• GSD can be incorporated to discharge 1.8
– First analysis after all phase 3 studies completey p p
– Second analysis after maximum # events reached
• Design 1st CV study to ensure enough events to meet 1.8 as
soon as phase 3 st dies completesoon as phase 3 studies complete
• May also assess HR < 1.3 (but may not be worth alpha
spend)
2nd CV study starts after approval
• GSD can be incorporated to discharge 1.3
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21. 2 CV Trials – The High Cost of Stopping 1st CV Study at Submission
Option 1 increases total cost by
6000 pts
$130 Million
Assumes: 2500 pts/yr recruited, 2% event rate
(cost: $30M fixed cost, $25k / patient, $2k / patient-year)
CV Study #1 – N=3500, Events=155, 3
Option #1: Stop at Submission
$
relative to option 2
CV Study #1 N 3500, Events 155, 3
years duration
CV Study #2 – N=8900, Events=545
CV Study #1 – N=3500, Events=460, 8 years duration
Option #2: Run CV #1 for 8 Years
5 Years Post Approval
CV Study #2 – N=2900, Events=240
Submission Approval
(trigger CV #2)
5 Years Post-Approval
(Complete CV #2)
700 Total Events CV #1 + CV #2
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22. Variation: Sub-studies
Sub-studies within CV design
– Initiated at time of Phase 3Initiated at time of Phase 3
– Goal: an indication within a patient subset
– Need to fully analyze sub-study at time of submission
– Ideally: Follow all patients to assess CV risk
– Alternative: discontinue patients in sub-study
Need acceptable process to maintain blind of ongoing
studies
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23. Single Large Development Study
(Core Phase 3 study)
End of Study
Analysis for
Submission
Dose A + SOC
Treatment Period FU
Run In Dose B + SOC
Population:
N=xxxx
80% high risk T2DM
20% std risk T2DM
Placebo + SOC
• No change in SOC for initial 6 months post randomization; modifications allowed thereafter
• Interim analysis conducted for HbA1c assessment after all patients followed for 6 months
All ti t ti i t i l th ft f MACE t ( d f t d )
Allowed Treatment Combinations
• add on to metformin
• add on to SU• All patients continue in trial thereafter for MACE assessment (end of study = x years) • add on to SU
• add on to Met + SU (EU)
• add on to TZDs
• add on to insulin
• add on to DPPIV
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Adapted from A. Svensson Roche DIA EU CV Safety Conference 2011
• add on to GLP1
24. Concluding Remarks
Integrate CV evaluation with the clinical plan
– Plan should include both 1.8 and 1.3
Efficiencies gained by considering EARLY the totality of information needed– Efficiencies gained by considering EARLY the totality of information needed
Consider GSD
– Choice of spending function Sponsor’s decision
– Preference for O’Brien-FlemingPreference for O Brien Fleming
– Adjusted point estimator of HR should be reported
Need to establish operational approaches for interim analyses
– Important to maintain trial integrity AND cost/benefit of datag y
– Industry needs to put forwarded models
Other key considerations not discussed
– Only high-level concepts presented
– E.g. endpoint (MACE, MACE +), patient population, heterogeneity
Other (more novel) approaches not discussed
– Shared control designs
Leveraging historical information– Leveraging historical information
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