This case study begins with an overview of the company’s pressing need to
identify areas to drive productivity and reduce costs in the Clinical Development
organization.
Utilizing the DMAIC principle of Six Sigma (Define, Measure, Analyze, Improve,
and Control), the case study walks through the steps highlighting the challenges
and achievements along the way.
Título original
Case Study on Six Sigma (2014 ExL Conference-Philly)
This case study begins with an overview of the company’s pressing need to
identify areas to drive productivity and reduce costs in the Clinical Development
organization.
Utilizing the DMAIC principle of Six Sigma (Define, Measure, Analyze, Improve,
and Control), the case study walks through the steps highlighting the challenges
and achievements along the way.
Direitos autorais:
Attribution Non-Commercial (BY-NC)
Formatos disponíveis
Baixe no formato PDF, TXT ou leia online no Scribd
This case study begins with an overview of the company’s pressing need to
identify areas to drive productivity and reduce costs in the Clinical Development
organization.
Utilizing the DMAIC principle of Six Sigma (Define, Measure, Analyze, Improve,
and Control), the case study walks through the steps highlighting the challenges
and achievements along the way.
Direitos autorais:
Attribution Non-Commercial (BY-NC)
Formatos disponíveis
Baixe no formato PDF, TXT ou leia online no Scribd
IPSEN 1 Views and comments provided from this presentation are solely of the presenter and do not in anyway represent the views and/or comments of Ipsen. 2 ! As the Clinical Development stage is the most expensive phase of bringing a new drug to market, nearly every pharmaceutical company over the past decade has placed much emphasis on finding new ways to increase productivity and process improving. ! This case study begins with an overview of the companys pressing need to identify areas to drive productivity and reduce costs in the Clinical Development organization. ! Utilizing the DMAIC principle of Six Sigma (Define, Measure, Analyze, Improve, and Control), the case study walks through the steps highlighting the challenges and achievements along the way. 3 ! Rising costs to develop new drugs ! Challenges in meeting enrollment goals in clinical trials ! Lost future revenues for delays in clinical development
4 ! A cross-functional team was assembled to evaluate ways to accelerate timelines in clinical development trials ! Careful consideration was taken to include the right key stakeholders on the core team ! Frequent communication throughout the development of the initiative was essential 5 Define Measure Analyze Improve Control 6 ! The D (Define) in the DMAIC process focuses on selecting high-impact areas to focus on ! Very important to have the team collectively define the problem ! What may be perceived as the easiest step, can be a challenge ! A key deliverable in the Define phase is a team charter Define 7 Problem Statement:
Delays in clinical trial execution result in delays to bring promising new medicines to patients in need, increased costs to bringing new drugs to market which translate to higher prescription prices.
Scope: US Clinical Development and US Clinical Operations. This initiative will focus on the critical path activities of clinical trial operations examining every step from protocol development to FPFV Areas of Focus: Protocol Development Site identification Contracting cycle-time Delays in trial launch (FPFV) Approach: Utilize Six Sigma principles: DMAIC Define, Measure, Analyze, Improve, Control Conduct further interviews with key stakeholders to further define needs and validate proposed solutions Core Team Members: Name - Name Name - Name Name - Name Name - Name Name - Name
Key Metrics to Measure Success: +15% improvement in protocol development cycle- time +15% improvement in SSU cycle-time -15% reduction in number of non-enrolling centers Timelines: Conduct kick-off mtg and define and align team on objectives Analyze off-site feedback and Identify potential work streams For further review with the CDMA Leadership team Produce recommendations and share with CDMA Leadership 8 ! The M (Measure) in the DMAIC is about documenting the current process, validating how it is measured, and assessing baseline performance. ! We utilized tools in this phase which include trend charts, fishbone diagram, critical path method process flowcharts, and stick diagrams, ! Its critical to measure the right things and to establish acceptable baselines ! By creating a critical path process chart, the team can focus in on what steps are important that if delayed, will extend the entire project. ! Establish baselines such as: ! Step A ! to ! Step B should take at most 2 weeks to complete Measure 9 ! The A (Analyze) in the DMAIC is when the team isolates the top causes behind the metric being investigated. ! It can be the most time-consuming phase. ! Can lead right into identifying the possible solutions (Improve stage) and often can be done together ! We utilized the fishbone diagram tool Was most valuable Analyze Problem Causes Causes Fishbone Diagram 10 ! A.K.A. Cause and Effect diagram ! Very useful in opening up dialogue among cross- functional team members ! Was most effective to identify where the root problems were
Problem Causes Causes Fishbone Diagram Analyze 11 Getting study sites up and running during start-up takes too long (avg = 19 weeks) Contracts take too long to negotiate Fishbone Diagram Purchase new external FMV tool (PICAS) Create new Contract Manager Role CRAs and Study Mgrs. too busy during SSU with other priorities No organized internal or external benchmarks used for assessing FMV Study Managers/CRAs not experienced to negotiate contract language Initial legal review takes >3weeks avg. Legal staff under reasourced 80% of sites demand more compensation than offered CRAs not empowered to negotiate Develop pre-approved back-up language. Free us Study Mgrs/CRAs by centralizing the SSU activities. Establish master agreements with repeat centers 12 Protocol Development, Site Selection and SSU can be improved Fishbone Diagram Studies often have a high % of non-enrolling sites Country feasibility assessments not done consistently Too often the protocols change significantly after sites are selected Wrong sites are selected Redesign Country Feasibility Process Change Site Selection SOP to have process start AFTER final protocol is produced Site selection done too early (prior to final protocol) Lack of training and awareness on importance of country feasibility assessments Contracts take too long to negotiate Purchase new external FMV tool (PICAS) Create new Contract Manager Role CRAs and Study Mgrs. too busy during SSU with other priorities No organized internal or external benchmarks used for assessing FMV Study Managers/CRAs not experienced to negotiate contract language Initial legal review takes >3weeks avg. Legal staff under reasourced 80% of sites demand more compensation than offered CRAs not empowered to negotiate Develop pre-approved back-up language. Free us Study Mgrs/CRAs by centralizing the SSU activities. Establish master agreements with repeat centers 13 ! The I (Improve) in the DMAIC is when the team focuses on fully understanding the top causes identified in the Analyze phase, ! with the intent of either controlling or eliminating those causes to achieve improved performance. ! The overall theme for the Improve phase is process redesign ! Can often be done at the time the team is in the Analyze phase Improve 14 ! The C (Control) in the DMAIC is how the organization sets up controls and monitors the effects of the changes made in the Improve phase to guarantee lasting results. ! Often there are process settings, setup procedures, etc., that require employees to follow specific requirements in daily operations ! these items are typically documented in a control plan. ! In cases like this the Six Sigma team should do everything possible to error-proof the process, and should then add the appropriate checks and balances to the quality system for the long run ! Develop a scorecard that includes the key metrics the team defined and have regular reviews with respective leadership Control 15 !" !# !$ !% of non-enrolllng slLes < 13 22 20 18 16 Medlan ConLracLlng Cycle-1lme (Local l88 slLes) < 14 weeks 19 weeks 18 weeks 12 weeks 12 weeks Medlan ConLracLlng Cycle-1lme (CenLral l88 slLes) < 3 weeks 8.3 weeks 6 weeks 4.3 weeks 4.3 weeks Medlan 1oLal SSu cycle-Llme (proLocol flnallzed Lo llv) < 10 weeks 14.3 weeks 11.3 weeks 10.3 weeks 10.3 weeks of 1oLal SlLes ldenLlfled/Conflrmed by +2 weeks afLer llnal roLocol > 90 30 82 89 92 &'()*+ ,*-./( 16 ! Encourage a Six Sigma Mind-Set within your organizations ! Eliminate the thinking that, its always been done this way. ! Company leaders are continually looking to streamline operations and improve processes ! When starting a process improvement effort, ensure you get buy-in (sponsorship) from all relevant stakeholders within your organization ! Throughout the process, provide continual updates to sponsors ! Carefully define your problem statement and project charter in the beginning with input from the team involved. 17 18