Copyright © 2013 Quintiles
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Introduction to Clinical Trials
Clinical trials are the scientific process for measuring whether new drugs are safe and effective.
James Lind, physician (1747) pioneered the field of clinical research > Discovery Citrus fruits prevented scurvy.
Sir Austin Bradford Hill, epidemiologist (1946) 1st randomised controlled trial (RCT) Streptomycin to treat tuberculosis
Regulatory agencies have used clinical trials ever since to determine whether a new drug is ready for the public.
1019 Novel drugs approved by the FDA
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How much does it cost to develop a new medicine?
A. £436 millionB. £533 millionC. £710 millionD. £916 millionE. £1.15 billion
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How much does it cost to develop a new medicine?
A.
B.
C.
D.
E.
£436 million
£533 million
£710 million
£916 million
£1.15 billion
Closed
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How long does it take to gain approval for a new medicine?
A. 4.5 yearsB. 7 yearsC. 8.5 yearsD. 12.5 yearsE. 14 years
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How long does it take to gain approval for a new medicine?
A.
B.
C.
D.
E.
4.5 years
7 years
8.5 years
12.5 years
14 years
Closed
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How many medicinal candidates are required for the approval process?
A. 3,500B. 15,000C. 7,500D. 1,200E. 500
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How many medicinal candidates are required for the approval process?
A.
B.
C.
D.
E.
3,500
15,000
7,500
1,200
500
Closed
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Drug development process
Drug discovery
Pre clinical testing
Phase I Phase II Phase III Licensing Approval
4.5 years 5.5 years 7 years 8.5
years11
years12.5
years
£436 million
£533 million
£710 million
£916 million
£1.1 billion
£1.15 billion
5,000 – 10,000
candidates10-20
candidates5-10
candidates2-5
candidates1-2
candidates1
medicine
Reference source: abpi publication Time to flourish Inside innovation; the medicine development process
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Do you have 5 minutes?
“Susie do you have 5 minutes to meet today?
An interesting opportunity has just come up that I think will suit your strengths and provide you with the development opportunity you need to progress”.
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Background to clinical trial
Key facts
Contract TripartiteMulti million $ Including bonus & penalty
Phase 3 (Clinical trial)
Therapeutic Area
Female Health
Geography 30 countries300 sites
Patients Over 9000 women
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Ahead on schedule, behind on morale
Team Health/Morale way down as evidenced
by diagnostic surveyTime
Quality
Team
CostNo major quality
concerns
No budgetary problems
8 months ahead of schedule
in an 18 month period
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Diagnostic Survey
• Background• Data tabulated and held at 3rd party • Performed on a yearly basis during the life of the project• Original Survey designed initially for discovery/development alliances
• What the survey is …• A diagnostic tool to understand the “health” /current state of the
partnership, and what issues need to be focused on in "real time“
• What the survey is not: …• An assessment of the Partner • A tool for the partnership to be "perfect“
Performance metric
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Survey Content
• Survey perspective (questions asked about the partner, supplier and liaison between parties)
• Ratings on five point scale from strongly agree to strongly disagree
• Scores grouped into 13 categories across three dimensions
Strategic Fit Operational Fit Cultural Fit
Commitment Communication Perf. Measurement Flexibility
Strategy Conflict Management
Roles Knowledge Mgmt
Trust/Fairness Decision Making Skills/Competence
Leadership Team Coordination
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Quintiles / Client (Drug X)Survey Demographics – sample 1 year
High level of “buy in”Sustained over 3 year periodResponders - governance, global management team and service domain leads from both parties
Group name QuestionnairesSent out
Responses received
Percentagecompletion
Client Team 22 20 86
Quintiles Team 34 28 82
All 56 48 84
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Client Team Respondents Yr-Yr
Commitment
Strategy
Trust/Fairness
Communication
Conflict Management
Decision Making
LeadershipPerformance Measurement
Roles
Skills/Competence
Team Coordination
Flexibility
Knowledge ManagementCultural FitStrategic Fit
Operational Fit
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Year 3
Year 2
Year 1
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Solution and Results
Solutions ResultsAcknowledged that there was a problem Improved team morale
Ongoing access to a “Neutral/Independent” Facilitator Evolved into a team recognised as high performing team
Team members from all parties brought together in one location to confront the problem
Team awarded “Team spirit of the year award”
Team members from all parties invited to determine solutions
Team members from all parties although dispersed into other projects and companies are still in contact and all still using versions of the laminated card
Selective changes to personnel Demonstrated Senior Management Commitment to make team successful
Introduction of 90 day work cycle Re enforced joint accountability for deliverables and timeline
Joint shared yearly goals incorporated into all team members goal and objectives
Improved collaboration and recognition all working towards one shared goal
Team developed jointly agreed team behaviours Production of a laminated card which assisted in behavioural changes
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Client and Quintiles overall objectives unchanged
Mutual
Client
Within budgetTo contractOn scheduleFinancial and regulatory compliance
DRUG LICENSE APPROVAL
Services match the contract(within budget and tospecifications)
Projects delivered onSchedule, within budget;service fees, pass Through costs and PI fees
Accurate forecasting –Predictable spend
Services match the contract(within budget and tospecifications)
Profit - Projects delivered on or ahead of schedule under budget
Client satisfaction Future business = GROWTH
Quality – fit for purpose
Quintiles
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Key element 90 day Work Cycle (1)
Steering Committee Members in both companies keen to ensure planning and pro-activity through effective:
Identification of future priorities
Planning to meet future priorities
Monitor / control achievement of future priorities targets
Audit trail / evidence targets being achieved on schedule
Measurement of team performance & areas to improve
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Key element90 day Work Cycle (2)
Project goals performance graph
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Strategic Intent
Project goals and metrics were clearly outlined up front and surpassed or met at the completion of the trial. The Pharmaceutical company/Quintiles partnership redefines the way trials are run and serves as a successful case study for both companies. Team members, investigative sites, patients are energized and remain committed to the trials throughout the project.
The conduct of the drug X clinical trials will increase knowledge of the disease state and provide benefit to the patients.
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General•Clear roles and responsibilities•Think globally – plans should be thoroughly tested across regions – support through project documentation eg. one global clinical mgt plan•Think broadly and communicate widely to share solutions•Share the big picture across the team/ investigators•Scheduled face to face meetings•Full engagement from all team members/appropriate workload to deliver•Contingency plans•Bring all experiences to bear and implement best practices•Actively manage personnel transition with quick integration•Ongoing assessment of team performance•Frank, timely and honest feedback (+ and -)
Mindset•Expect challenges – silence NOT agreement•Be Fair -no finger pointing/blaming•Respect•Frank, timely and honest feedback (+ and -)•Be Creative•Don’t take it personally•Don’t overpromise – if you don’t know, say so and follow up•Direct people to the right source•Assume trust and commitment – benefit of the doubt•Celebrate Success
Communication•Open, honest and frequent communication•Explain why in order to create buy-in•Set clear expectations - include metrics, timeline, responsibility, priority
• If expectations aren‘t clear, ask!•Communicate when you have concerns
• Seek efficiency•Be clear about decisions – who, when
Trust = Credibility + Reliability + IntimacySelf-orientation
Credibility = Accuracy and completeness; believability and honestyReliability = The repeated link between promises and actionIntimacy = “Emotional closeness” concerning the issues at handSelf-orientation = Focusing on yourself rather than your partner
Operating Principles
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Trust = Credibility + Reliability + IntimacySelf-orientation
Credibility = Accuracy and completeness; believability and honestyReliability = The repeated link between promises and actionIntimacy = “Emotional closeness” concerning the issues at handSelf-orientation = Focusing on yourself rather than your partner
Operating Principles
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Learning and reflection …
Perceptions can vary between those involved in a project and their
senior managers
Conflicting vision can impact adversely on individual and team morale
Recognising and addressing this type of conflict can be difficult and
may require investment – facilitation is key
Acknowledging and resolving conflict can be very rewarding for all
concernedSusie Boyce
Director, Clinical Project Management, PMP, CSci, BScCNS – Psychiatry
QuintilesNavigating the new health
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