Management of Epistaxis in Patients on Anti-Platelet and/ Or Anticoagulant Me...QUESTJOURNAL
Objective: To analyse necessity to withhold regular anticoagulant and/or antiplatelet medications to control epistaxis by introducing a modified protocol for management of such patients. Method: One hundred and eighteen patients admitted with epistaxis were studied. First audit was a retrospective study to observe current practice. Second audit was carried out as a prospective study over the period of six months following modified treatment algorithm. These audits were compared on the basis of duration of hospital stay, need for surgical intervention, readmissions, re-bleed, drop in INR below target range. Results: In this non-inferiority analysis the main interest is in the lower bound of the 90% confidence interval (CI) since we want to make sure the second audit approach is not much worse than the first audit approach. Conclusion: The outcomes of the second audit were not significantly worse than first audit. As anti-platelet and anticoagulants were continued, we postulate that potential risks associated with stopping these medications (ie.risk of thrombo-embolism) were reduced without compromising epistaxis control.
Emerging diagnostic technologies proving the clinical application through g...Lyssa Friedman
Next Generation Sequencing is an exciting new technology for diagnostics companies. But is it right for all products and for all companies? This presentation was delivered via Webinar for a IVD audience for Q1 Productions, March 25, 2014.
Strategies for Considerations Requirement Sample Size in Different Clinical T...IJMREMJournal
-------------------------------------------------------ABSTRACT ---------------------------------------------------
Usually the main problem face any investigation it how to determent a sample size, however, some
considerations required in sample size to conduct the efficacy and make realistic well-researched before began
study. This study aimed to determine the maximum possible sample size at different phases of clinical trials and
attempt to achieve the best accuracy of the results. To achieve that the maximum sample size in different phases
we found that the maximum sample size of phase I was (75) relies on largest response rate 20% and the minimal
clinically important difference (MCID) 15%, and because the participants are healthy often that means 15%
enough to show positive results of the transition to the second phase. for the phase II clinical trials; the
maximum sample size was (388) depend on the error 5% and largest response rate 50% when the response rate
should not be less than 20% according to the design used in this phase. Depend on the endpoint and hazard
ratio in phase III clinical trials when the probability of survival of the treatment group equal to median of the
probability of survival 50% we found that the maximum sample size (4796). For the phase IV the maximum
sample size in different phases of clinical trials does not affect whatever the large of the population size and
remains constant as large as possible size.
Management of Epistaxis in Patients on Anti-Platelet and/ Or Anticoagulant Me...QUESTJOURNAL
Objective: To analyse necessity to withhold regular anticoagulant and/or antiplatelet medications to control epistaxis by introducing a modified protocol for management of such patients. Method: One hundred and eighteen patients admitted with epistaxis were studied. First audit was a retrospective study to observe current practice. Second audit was carried out as a prospective study over the period of six months following modified treatment algorithm. These audits were compared on the basis of duration of hospital stay, need for surgical intervention, readmissions, re-bleed, drop in INR below target range. Results: In this non-inferiority analysis the main interest is in the lower bound of the 90% confidence interval (CI) since we want to make sure the second audit approach is not much worse than the first audit approach. Conclusion: The outcomes of the second audit were not significantly worse than first audit. As anti-platelet and anticoagulants were continued, we postulate that potential risks associated with stopping these medications (ie.risk of thrombo-embolism) were reduced without compromising epistaxis control.
Emerging diagnostic technologies proving the clinical application through g...Lyssa Friedman
Next Generation Sequencing is an exciting new technology for diagnostics companies. But is it right for all products and for all companies? This presentation was delivered via Webinar for a IVD audience for Q1 Productions, March 25, 2014.
Strategies for Considerations Requirement Sample Size in Different Clinical T...IJMREMJournal
-------------------------------------------------------ABSTRACT ---------------------------------------------------
Usually the main problem face any investigation it how to determent a sample size, however, some
considerations required in sample size to conduct the efficacy and make realistic well-researched before began
study. This study aimed to determine the maximum possible sample size at different phases of clinical trials and
attempt to achieve the best accuracy of the results. To achieve that the maximum sample size in different phases
we found that the maximum sample size of phase I was (75) relies on largest response rate 20% and the minimal
clinically important difference (MCID) 15%, and because the participants are healthy often that means 15%
enough to show positive results of the transition to the second phase. for the phase II clinical trials; the
maximum sample size was (388) depend on the error 5% and largest response rate 50% when the response rate
should not be less than 20% according to the design used in this phase. Depend on the endpoint and hazard
ratio in phase III clinical trials when the probability of survival of the treatment group equal to median of the
probability of survival 50% we found that the maximum sample size (4796). For the phase IV the maximum
sample size in different phases of clinical trials does not affect whatever the large of the population size and
remains constant as large as possible size.
Slides from the presentation on extrapolation from progression free survival to overall survival in oncology given at the 2017 HTAi Annual Meeting in Rome
Fast-track surgery - the role of the anaesthesiologist in ERASscanFOAM
A presentation by Narinder Rawal at the 2017 meeting of the Scandinavian Society of Anaestesiology and Intensive Care Medicine.
All available content from SSAI2017: https://scanfoam.org/ssai2017/
Delivered in collaboration between scanFOAM, SSAI & SFAI.
Part of the MaRS BioEntrepreneurship series session: Clinical Trials Strategy
Speaker: Miklos Schulz
This is available as an audio presentation:
http://www.marsdd.com/bioent/feb12
Also view the event blog and summary:
http://blog.marsdd.com/2007/02/14/bioentrepreneurship-clinical-trial-strategies-its-never-too-soon/
Slides from the presentation on extrapolation from progression free survival to overall survival in oncology given at the 2017 HTAi Annual Meeting in Rome
Fast-track surgery - the role of the anaesthesiologist in ERASscanFOAM
A presentation by Narinder Rawal at the 2017 meeting of the Scandinavian Society of Anaestesiology and Intensive Care Medicine.
All available content from SSAI2017: https://scanfoam.org/ssai2017/
Delivered in collaboration between scanFOAM, SSAI & SFAI.
Part of the MaRS BioEntrepreneurship series session: Clinical Trials Strategy
Speaker: Miklos Schulz
This is available as an audio presentation:
http://www.marsdd.com/bioent/feb12
Also view the event blog and summary:
http://blog.marsdd.com/2007/02/14/bioentrepreneurship-clinical-trial-strategies-its-never-too-soon/
Clinical Validation of Copy Number Variants Using the AMP GuidelinesGolden Helix
The common approaches to detecting copy number variants (CNVs) are chromosomal microarray and MLPA. However, both options increase analysis time, per sample costs, and are limited to the size of CNV events that can be detected. VarSeq’s CNV caller, on the other hand, allows users to detect CNVs from the coverage profile stored in the BAM file, which allows you to utilize your existing NGS data and perform the analysis all in one suite. Coupled with this innovative feature is the ability to annotate CNV events against a variety of databases, and by incorporating our VSClinical AMP workflow, we can now assess CNVs as potential biomarkers. Most importantly, Golden Helix CancerKB is an AMP workflow feature that provides expert-curated biomarker interpretations, including those for common somatic CNVs, that will streamline the analysis time and report generation.
In this demonstration we will cover:
Setting up the VS-CNV caller using BAM files from whole exome data
Filtering down to high quality, high confidence CNV events
Annotating CNVs using publicly curated catalogs and databases
Adding clinically relevant CNVs to the VSClinical AMP workflow
Utilizing Golden Helix CancerKB to obtain expert-curated interpretations
Showing updated features and polishes to the software
Together, VarSeq incorporates the ability to accurately call and annotate CNVs and evaluate germline and somatic mutations according to the ACMG and AMP guidelines, respectively. This webcast demonstration will provide insight into these best practice workflows and will hopefully show you how you can implement this top-quality software into your pipeline solution.
The study explores major factors that contribute to hospital readmissions via various analysis algorithms, including decision tree, neutral network and Bayesian network.
Introducing Drugs & Trials for Cancer DiagnosticsGolden Helix
When interpreting a variant using the AMP/ASCO guidelines for somatic variant interpretation, clinicians must determine whether the variant can be considered a biomarker that affects clinical care by predicting sensitivity, resistance, or toxicity to a specific therapy. Such a determination requires the investigation of multiple evidence sources, including clinical trials, FDA approved therapies and peer-reviewed studies. Unfortunately, strong evidence linking specific genetic biomarkers to FDA-approved therapies only exists for a small number of cancers. Thus, most variants require an exploration of clinical practice guidelines, peer-reviewed literature, and large-scale cancer mutation databases to effectively assess the clinical significance of a given mutation.
This webcast explores this new incorporation of Drugs & Trials Annotations in VSClinical's AMP Workflow covering:
Identification of relevant clinical evidence for drug sensitivity and resistance based on patient biomarkers and tumor type
Review of clinical trial information including inclusion criteria, trial status, and contact information
Management of citations associated with relevant, targeted therapies
Evaluation of a biomarkers clinical evidence tier based on available evidence for drug sensitivity and resistance
the role of Cochrane collaboration and specifically the menstrual disorder & subfertility group is illustrated . simple explanation how to use cochrane reviews is done.
Clinical trials are the gold standard of evidence-based medicine. Properly designed clinical trials can lead to chance findings and potentially lead to erroneous conclusions.
Importantly, clinical trials can also be badly designed on purpose to increase the risk of false or chance findings leading to support misleading claims. Such techniques are frequently used by bad researchers and charlatans to substantiate their claims with biased clinical trials. It is therefore important to be weary of the limitations of clinical trials and understand how causal inference should be approach. In that presentation, I discuss the situations under which the risk of erroneous conclusions from clinical trials is increased and I discuss ways to identify and prevent bad clinical research.
The views expressed and presented in that presentation are my own views and may not represent the views of the National Institute for Health and Care Excellence.
Importanza anestesista in oftalmologia 2013;role of the anesthesiologists in ...Claudio Melloni
Role of the anesthesiologist in ophthalmic surgery;cases,monitoring, challenges,screening of patients,complications,discussion from literature and more .dangers of Phenylephrine,accidents.
Heavy file,with documents not properly pictured,but useful for discussion.
Clinical Science for Medical Devices: A Guide for Entrepreneurs | Jim Gustafs...UCICove
About UCI Applied Innovation:
UCI Applied Innovation is a dynamic, innovative central platform for the UCI campus, entrepreneurs, inventors, the business community and investors to collaborate and move UCI research from lab to market.
About the Cove @ UCI:
To accelerate collaboration by better connecting innovation partners in Orange County, UCI Applied Innovation created the Cove, a physical, state-of-the-art hub for entrepreneurs to gather and navigate the resources available both on and off campus. The Cove is headquarters for UCI Applied Innovation, as well as houses several ecosystem partners including incubators, accelerators, angel investors, venture capitalists, mentors and legal experts.
Follow us on social media:
Facebook: @UCICove
Twitter: @UCICove
Instagram: @UCICove
LinkedIn: @UCIAppliedInnovation
For more information:
cove@uci.edu
http://innovation.uci.edu/
Similar to Biostatistics in development of Medical Devices By T. Mudde - Clinquest (Qserve Conference 2013) (20)
The world of search engine optimization (SEO) is buzzing with discussions after Google confirmed that around 2,500 leaked internal documents related to its Search feature are indeed authentic. The revelation has sparked significant concerns within the SEO community. The leaked documents were initially reported by SEO experts Rand Fishkin and Mike King, igniting widespread analysis and discourse. For More Info:- https://news.arihantwebtech.com/search-disrupted-googles-leaked-documents-rock-the-seo-world/
Affordable Stationery Printing Services in Jaipur | Navpack n PrintNavpack & Print
Looking for professional printing services in Jaipur? Navpack n Print offers high-quality and affordable stationery printing for all your business needs. Stand out with custom stationery designs and fast turnaround times. Contact us today for a quote!
Implicitly or explicitly all competing businesses employ a strategy to select a mix
of marketing resources. Formulating such competitive strategies fundamentally
involves recognizing relationships between elements of the marketing mix (e.g.,
price and product quality), as well as assessing competitive and market conditions
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Improving profitability for small businessBen Wann
In this comprehensive presentation, we will explore strategies and practical tips for enhancing profitability in small businesses. Tailored to meet the unique challenges faced by small enterprises, this session covers various aspects that directly impact the bottom line. Attendees will learn how to optimize operational efficiency, manage expenses, and increase revenue through innovative marketing and customer engagement techniques.
Discover the innovative and creative projects that highlight my journey throu...dylandmeas
Discover the innovative and creative projects that highlight my journey through Full Sail University. Below, you’ll find a collection of my work showcasing my skills and expertise in digital marketing, event planning, and media production.
Attending a job Interview for B1 and B2 Englsih learnersErika906060
It is a sample of an interview for a business english class for pre-intermediate and intermediate english students with emphasis on the speking ability.
Enterprise Excellence is Inclusive Excellence.pdfKaiNexus
Enterprise excellence and inclusive excellence are closely linked, and real-world challenges have shown that both are essential to the success of any organization. To achieve enterprise excellence, organizations must focus on improving their operations and processes while creating an inclusive environment that engages everyone. In this interactive session, the facilitator will highlight commonly established business practices and how they limit our ability to engage everyone every day. More importantly, though, participants will likely gain increased awareness of what we can do differently to maximize enterprise excellence through deliberate inclusion.
What is Enterprise Excellence?
Enterprise Excellence is a holistic approach that's aimed at achieving world-class performance across all aspects of the organization.
What might I learn?
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Who might benefit? Anyone and everyone leading folks from the shop floor to top floor.
Dr. William Harvey is a seasoned Operations Leader with extensive experience in chemical processing, manufacturing, and operations management. At Michelman, he currently oversees multiple sites, leading teams in strategic planning and coaching/practicing continuous improvement. William is set to start his eighth year of teaching at the University of Cincinnati where he teaches marketing, finance, and management. William holds various certifications in change management, quality, leadership, operational excellence, team building, and DiSC, among others.
What are the main advantages of using HR recruiter services.pdfHumanResourceDimensi1
HR recruiter services offer top talents to companies according to their specific needs. They handle all recruitment tasks from job posting to onboarding and help companies concentrate on their business growth. With their expertise and years of experience, they streamline the hiring process and save time and resources for the company.
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LA HUG - Video Testimonials with Chynna Morgan - June 2024Lital Barkan
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This 60-minute webinar, sponsored by Adobe, was delivered for the Training Mag Network. It explored the five elements of SPARK: Storytelling, Purpose, Action, Relationships, and Kudos. Knowing how to tell a well-structured story is key to building long-term memory. Stating a clear purpose that doesn't take away from the discovery learning process is critical. Ensuring that people move from theory to practical application is imperative. Creating strong social learning is the key to commitment and engagement. Validating and affirming participants' comments is the way to create a positive learning environment.
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4. EUROPEAN GUIDELINES
“Clinical data must be provided for ALL medical devices. This may be
literature review or clinical investigation depending on device class and
use.”
When must/should a clinical investigation be undertaken?
To ensure a high level of safety and performance, demonstration of
compliance with the general safety and performance requirements
should be based on clinical data that, for class III medical devices and
implantable medical devices should, as a general rule, be sourced
from clinical investigations to be carried out under the responsibility of
a sponsor who can be the manufacturer or another legal or natural
person taking responsibility for the clinical investigation.
Depending on clinical claims, risk management outcome and on the
results of the clinical evaluation, clinical investigations may also have
to be performed for non-implantable medical devices of classes I, IIa
and IIb.
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Clinquest Services Qserve Conference
5. FDA GUIDELINES
The collection and evaluation of sound clinical data are the basis of
the approval process for many medical devices.
Goals for device studies (including IVD studies) are:
•
Producing valid scientific evidence, demonstrating
reasonable assurance of the safety and effectiveness of the
product
•
Protecting the rights and welfare of study subjects
Clinquest Services Qserve Conference
5
6. FDA GUIDELINES
Valid scientific evidence is defined as:
“Evidence from well-controlled investigations, partially controlled
studies, studies and objective trials without matched controls,
well-documented case histories conducted by qualified experts,
and reports of significant human experience with a marketed
device, from which it can fairly and responsibly be concluded by
qualified experts that there is a reasonable assurance of the
safety and effectiveness of a device under its conditions of use.”
Clinquest Services Qserve Conference
6
7. GUIDELINES
Clinical Investigation Plan
The clinical investigation plan (CIP) shall define:
•
•
•
•
•
•
•
•
Rationale of the clinical investigation
Study objectives
Study design
In/exclusion criteria
Endpoint choice
Proposed analyses: statistical considerations
Monitoring
Conduct and record-keeping: data management
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8. GUIDELINES
Statistical Section Clinical Investigation Plan
The statistical section should at least include:
•
•
•
•
•
•
•
•
Analysis populations used
Missing data strategy
Definition of endpoints
Hypotheses to be tested (efficacy/safety endpoints)
Planned statistical methodology
Sample size justification
Sensitivity analyses planned
Planned interim analyses
•
Detailed Statistical Analysis Plan
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10. PRECISION
X
/ BIAS
x
X
x
x
x
x x
x
xxx
Precision small
Bias large
X
Precision large
Bias large
x
X
x
x
x x
x
x x
x
x
Precision small
Bias small
Precision large
Bias small
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11. PRECISION
/ BIAS
•
Precision: random fluctuations
Maximizing precision by:
s
s.e.
- work with large samples
N
- work with homogeneous samples
- use paired designs (patient/sample is its own control)
- use extra information, e.g. baseline measurements
•
Bias: systematic deviate from true result
Minimizing bias by:
- randomization (decreases selection bias and impact of
confounding)
- blinding (decreases observation bias)
- use extra information, e.g. baseline measurements (decreases
impact of confounding)
- avoid missing data
Clinquest Services Qserve Conference
11
12. EXAMPLE
STENT STUDY
Comparison of Stenting versus Balloon Angioplasty (PTA) for the
treatment of below the knee artery disease (Class III).
Efficacy Study Objective:
- Does our Stent perform better than balloon angioplasty?
Ethical, control standard care
Design:
-
Parallel Arm, Multiple Centers
Superiority Trial
Randomized?
Yes
Blinded?
No
Duration FU?
Long enough for acceptable evaluation of
performance and safety (1 year)
- Interim Analyses? No
Primary efficacy endpoint:
- Binary in-segment stenosis at 12 months by angiography
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13. STENT STUDY
Possible bias:
- Objective primary endpoint
- Observation bias, blinding not possible
- Use ITT analysis population in case of
randomized study
- Confounding possible?
- Missing data
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14. ANALYSIS DATASETS
• ITT Analysis set:
All randomized patients; analyzed as
randomized.
• Full Analysis set: The analysis set that is as complete as
possible and as close as possible to the
intention to treat ideal of including all
randomized subjects (ICH).
• Per Protocol set:
Set of patients with minimal violations against
the protocol as: errors in treatment assignment,
use of excluded medication, poor compliance,
loss to follow-up and missing data; analyzed as
treated.
To be set before database lock.
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15. ANALYSIS DATA SETS
Angioplasty N1=50
5 patients too severe
5 patients go over on
stenting
R
Stent N2=50
•
•
ITT
PP
50 patients on stent 50 patients on angioplasty
55 patients on stent 45 patients on angioplasty
PP analysis generally used as sensitivity analysis
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16. BIAS BY CONFOUNDING VARIABLES
Mortality rate comparison
Hospital
A
Died
Survived
Total
Mortality rate
63
2037
2100
3.0%
Died
Survived
Total
Mortality rate
B
16
784
800
2.0%
Relative risk hosp. B vs. hosp. A = 0.66,
34% lower risk of dying in hosp. B than in
hosp. A
Total
79
2821
2900
Good Health
A
B
6
8
594
592
600
600
1.0%
1.3%
Relative risk hosp. B vs. hosp. A = 1.33,
33% higher risk of dying in hosp. B than
in hosp. A
Poor Health
A
B
57
8
1443
192
1500
200
3.8%
4.0%
Total
14
1186
1200
Total
65
1635
1700
Relative risk hosp. B vs. hosp. A = 1.05,
5% higher risk of dying in hosp. B than
in hosp. A
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Clinquest Services Qserve Conference
17. BIAS BY CONFOUNDING VARIABLES
Mortality rate confounded by health status because :
- Health status has impact on outcome
- Health status not equally distributed over the two hospitals
Died
Survived
Total
Mortality rate
Good Health
A
B
6
8
594
592
600
600
1.0%
1.3%
Total
14
1186
1200
Poor Health
A
B
57
8
1443
192
1500
200
3.8%
4.0%
Total
65
1635
1700
Statistical analysis: Adjusted relative risk hospital B vs. hospital A = 1.14,
14% higher risk of dying in hospital B than in hospital A, taking health status
into account.
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18. BIAS BY CONFOUNDING VARIABLES
HOW TO COPE WITH PROGNOSTIC/CONFOUNDING FACTORS ?
FACTORS?
•
Identical distribution of prognostic factors over treatment groups
(stratified randomization)
•
Subgroup analyses (problem of multiple testing and low power)
•
Retrospective control for prognostic/confounding factors during
statistical analysis
Confounding variable is a background factor which:
–
is not equally distributed over the risk groups
–
influences the outcome variable(s)
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19. STENT STUDY, HYPOTHESES TO BE TESTED
Primary efficacy endpoint:
H0 : π A = π B
no stent therapy effect
π A π B 0
HA : π A π B
stent therapy effect
π A π B 0
Try to reject H0
-If p-value < 0.05
-If p-value ≥ 0.05
reject H0: there is a statistically significant therapy effect
accept H0: there is no statistically significant therapy effect.
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20. STENT STUDY, STATISTICAL INFERENCE
ITT Population
50.0%
40.0%
Percentage with Stenosis
30.0%
20.0%
Stent Treatment
10.0%
PTA Treatment
0.0%
Difference
-10.0%
-20.0%
-30.0%
-40.0%
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22. STENT STUDY, MISSING DATA
Restenosis
No Restenosis
Total
Missing
Therapy
Stent (N=113)
PTA (N=115)
15 (22.4%)
31 (41.9%)
52
43
67
74
46 (40.7%)
41 (35.7%)
Total
46
95
141
87 (38.2%)
best case
Restenosis:
23 Stent,
21 PTA
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worst case
23. STENT STUDY, SAMPLE SIZE CALCULATION
Stent study:
With 61 lesions in each therapy arm, a clinically meaningful difference of
25% in 12 months in-segment restenosis rate can be detected with a
power of 80% at a two sided significance level of 5%, assuming a 12
months restenosis rate of 45% in the group of subjects who only receive
balloon angioplasty. The total sample size was increased to almost 110
lesions per therapy arm to account for a 45% drop out rate.
Restenosis
No Restenosis
Total
Missing
Therapy
Stent (N=113) PTA (N=115)
15 (22.4%)
31 (41.9%)
52
43
67
74
46
41
Total
46
95
141
87
Drop out rate: 38.2%
Power to detect 25% difference = 85.8%
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24. STENT STUDY, SAMPLE SIZE CALCULATION
•
Performed on the basis of assumptions concerning:
- How accurate can the primary endpoint be measured?
- What is the clinically significant difference you like to see
(HA)?
- What do you expect as outcome for the control group?
•
Performed on the basis of agreements about:
- significance level: (e.g. 5%)
- power: 1-
(e.g. 90%)
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25. STENT STUDY, SAMPLE SIZE CALCULATION
Hypothesis Testing
H0
Type I error / Type II error
HA
(Type I error)= Significance level
P(reject H0 | H0 is true) = P(false positive)
of the test
(1 - ) = Power of the test:
P(reject H0 | HA is true)
(Type II error):
P(accept H0 | HA is true) = P(false negative)
Power: Probability to accept correctly, by a given , the alternative
hypothesis.
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26. ADAPTIVE DESIGNS
Adaptive Design Clinical Study: a study that includes a
prospectively planned opportunity for modification of one or more
specified aspects of the study design and hypotheses based on
analysis of data (usually interim data) from subjects in the study
(FDA).
Goal: to make the study more efficient: shorter duration, fewer
patients, more information
Possible problems:
Operational bias: revisions not previously planned and made or
proposed after an un-blinded interim analysis raise major
concerns about study integrity.
Multiple testing: control of type I error rate
Regulatory concerns: FDA communication/review needed
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27. ADAPTIVE DESIGNS
Planned Adaptive Design
• Allocation Rule
- Can be fixed but can change based
on accruing data
• Sampling Rule
- How many subjects sampled at next
stage (cohort)
- Sample size recalculation based on
interim results
• Stopping Rule
- When to stop a trial: efficacy, futility
•
Decision Rule
- E.g. dropping study arm
Fixed Sample Design
- Randomization remains
fixed throughout the study
- Only one stage
- Fixed sample size
- No early stopping
- No changes
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28. EXAMPLE CIN-EVENT STUDY
Comparison experimental device system with standard hydration
protocol for preventing the incidence of CIN (Contrast Induced
Nephropathy), after the administration of contrast media. (Class
IIb).
Efficacy Study Objective:
- Evaluation of the comparability between experimental device and
standard care in CIN events within 3 days post contrast administration.
Design:
-
Parallel Arm, multiple centers
Superiority Trial
Randomized? Yes, stratified by Y/N NSTEMI
Blinded? No
Duration FU? 3 days for primary efficacy endpoint, 90 days for safety
Interim Analysis? Yes
Primary efficacy endpoint:
- CIN event within 3 days; missing information for CIN: failure
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29. CIN-EVENT STUDY, SAMPLE SIZE CALCULATION
Assumptions:
3-day CIN event rate control arm: 15%
Assuming 80% power and with a 1:1 randomization allocation ratio,
155 subjects in each group are required to demonstrate
the expected difference of 10% in the incidence of CIN between
groups at a significance level of 0.05 based on a 2-sided test.
The study will randomize a total of 326 patients to account for a 5%
lost to follow-up but based on the interim analysis, could
randomize up to a maximum of twice the initial sample size, or 652
patients.
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30. CIN-EVENT STUDY, SAMPLE SIZE RECALCULATION
ˆ
1 Measured difference at interim analysis
1 Expected difference at final analysis
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31. CIN-EVENT STUDY, SAMPLE SIZE RECALCULATION
Sample size recalculation will be performed based on the
method of modification of sample size in group sequential
clinical trials employing conditional power and maintaining type I
error rate. The sample size will be adjusted such that the
calculated conditional power obtained is 80%.
The trial can be stopped for reasons of overwhelming efficacy (pvalue<0.003) or futility (conditional power under the current trend
<20%).
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