SCDM 2017 ANNUAL CONFERENCE. September I Orlando
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1 SCDM 2017 ANNUAL CONFERENCE September I Orlando
2 01. Simple Statistical Tools to Assess Site Performance & Facilitate Site Monitoring Bernd Doetzkies Director Informatics Daiichi Sankyo, Inc All Rights Resered
3 Simple Statistical Tools to Assess Site Performance & Facilitate Site Monitoring The opinions expressed in this presentation and on the following slides are solely those of the presenter and not necessarily those of Daiichi Sankyo, Inc. Examples within this presentation are only examples and do not reflect actual data on CRO or site performance on clinical trials All Rights Resered
4 TABLE OF CONTENTS Simple Statistical Tools Basic SPC Concepts Why Should I Care? Risk of Using Traditional KPIs Big Data Equal Big Metrics Identify High Risk Areas to Ensure Due Diligence Pulling it All Together Closing Thoughts Resources & References
5 Simple Statistical Tools Introduce the basic concepts of: Statistical Process Control (SPC) and Statistical Quality Control (SQC) To monitor and manage clinical trial processes. If you can't measure it, you can't improe it. - Peter Drucker If you can t measure it, you can t manage it. - common misquote attributed to W. Edwards Deming The conduct of clinical trials and data collection is comprised of a number of complex processes that can be measured, controlled, and improed upon using SPC/SQC.
6 Simple Statistical Tools Statistical Process Control (SPC) 101 Concepts There is inherent ariability in eery system / process Use Control Charts with statistical control limits to analyze ariability A process has an aerage measurement A process has Upper and Lower Limits calculated using the process aerage + or 3 times the Standard Deiation Upper Control Limit Process Aerage Lower Control Limit
7 Simple Statistical Tools Statistical Process Control (SPC) 101 Concepts When a process is in control, we obsere random ariations around the Process Aerage - Common Cause Variability
8 Simple Statistical Tools Statistical Process Control (SPC) 101 Concepts When a process is out of control, we obsere statistically significant ariations - Special Cause Variability
9 Simple Statistical Tools Statistical Process Control (SPC) 101 Concepts When a process is out of control, identify root cause and take correctie action; monitor to confirm Process Shift Take Action to Correct
10 Why Should I Care? People spend unnecessary time and money chasing down random process ariations. Ability to identify risks and focus your time and effort to address real issues. Hae documented eidence that correctie actions were effectie. Traditional approach is to define CRO/Site Key Performance Indicators (KPI) Successful with regulatory requirements (SAE Reporting) Issue: KPIs targets can ary significantly by CRO, Region, Sites (een under approed contracts with KPIs)
11 Risk of Using Traditional KPIs
12 Risk of Using Traditional KPIs But happens in the real world? Risk spending unnecessary time and money chasing down random process ariations.
13 Risk of Using Traditional KPIs But happens in the real world? Site contracts ary 21 days for sites in South America 14 days for sites 3,6,9,12,18, 52
14 Risk of Using Traditional KPIs But happens in the real world? Site and CRO personnel & resourcing ariations
15 Risk of Using Traditional KPIs Improement of a process can begin only after statistical control has been established (Deming 1982) Implement Process Improements Process Shift # of Days From 1st SAE Query Issued to All Queries Closed
16 Big Data Equals Big Metrics Data from EDC, CTMS, IRT, etc. systems on performance Dashboards can offer 100 s of metrics to choose from with users able to use sliding scales to select performance thresholds (KPI-centric approach) Applying statistics to 10,000 x 10,000 (or 100k x 100k) data points will by chance identify statistically significant findings But are they meaningful? What process changes do you want to target? What risks do you want to mitigate?
17 Identify High Risk Areas to Ensure Due Diligence Categories of Safety, Subjects, and Data Remember to measure the dimensions that are critical to regulatory compliance and targeted process improements.
18 Pulling It All Together Use Pareto Charts, SPC Metrics, and Control Charts to drill down into real issues quickly A Pareto Chart you ask? It is a bar chart of eent frequencies displayed in descending order. It is based on the Pareto Principle, also called rule Pareto Charts are used to identify the frequency of problems or causes in a process. It helps you focus on the most significant problems or risks in a process.
19 Pulling It All Together Fictitious Inestigational Trial with 100 Sites FIT Study Assess Sites performance against process aerage Examples on use of Pareto Charts Drill Down on Site/CRO Performance Issues Examples on use to Control Charts Drill Down on Site/CRO Performance Issues Signal: Any Metric Value >= UCL or <= LCL
20 Pulling It All Together
21 Pulling It All Together
22 Pulling It All Together
23 Pulling It All Together
24 Pulling It All Together
25 Pulling It All Together
26 Pulling It All Together Run Rules One or more points beyond the 3 sigma upper or lower control limits 2 out of 3 consecutie points beyond the 2 sigma upper or lower control limits 4 out of 5 consecutie points beyond the 1 sigma upper or lower control limits 7 or more consecutie points on one side of the mean 7 consecutie points trending up or trending down 8 consecutie points with no points between the mean and 1 sigma upper or lower control limits 15 consecutie points between the mean and 1 sigma upper or lower limit 14 consecutie points alternating up and down
27 Closing Thoughts Consult with a Statistician or Quality Assurance expert knowledgeable in SPC before implementing There are 8 types of different Control Charts that can be used depending on the type of data being collected, how the data is collected, and the distribution of the data Attribute (Categorical) Variable (Continuous) Proportion of defect ersus number of defects or the rate of defects Aerage measures ersus range of measures or indiidual measures Don t be oerwhelmed with the statistics Start simple and keep it simple
28 Closing Thoughts Stop chasing common cause ariations, wishful KPIs, and focus on targeted process improements to make a difference Computer programs can be easily be set up to identify outliers, process shifts, etc. at both the macro leel and site leel to quickly identify issues that should be addressed Remember eery process or system has capacity or operational constraints that impact performance and quality Setting performance & quality goals without implementing effectie process monitoring and process changes is an exercise in futility
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