This document provides an overview of project planning and management for clinical trials. It discusses the importance of project management in moving research from the bench to the bedside. Key aspects of project management covered include establishing a management structure, developing a project plan using a Gantt chart, setting milestones, risk management, project monitoring, and managing the budget. The document emphasizes that project management requires defining objectives, planning the work, and communicating the plan to control scope, deliver results on time and budget, and obtain buy-in from stakeholders.

1. Project Planning and Management
Roger Tatoud, Ph.D.
Senior Programme Manager
International HIV Clinical Trials Research Management Office
Imperial College London
DPFS/DCS Workshop: 15 February 2013

2. Introduction
• Background
• From Bench to Bedside
• Project Management
• Why Project Management
• Management Structure
• Planning
• Gantt Chart
• Setting Milestones
• Risk Management
• Project Monitoring
• Budget and MRC T&C
• Your Project Manager
1

3. Background
2

4. Translational Medicine as a Linear Path
Basic
research
Prototype
Discovery &
Design
Pre-clinical
Develop-
ment
Early clinical
trials (I/II)
Late clinical
trials (III/IV)
Regulatory
approval
Marketing
Post
marketing
compliance
Patient
DPFS/DCS
3

5. Translational Medicine as a Mosaic
4

6. Systemic overview
5

7. What to do? Where to Start?
6
... Project Management is here to help!

8. • Poor definition of objectives
• Inadequate resources
• Poor team and capacity issues
• Poor communication
• Lack of a cross functional team
• Resistance to change
• Lack of top management commitment
• Poor leadership
• Poor baseline management
• Poor planning and control
• Technical problems not resolved
• Failure to anticipate problems
• Too many uncontrolled changes
• Lack of customer/user involvement
Why Projects Fail?
Adapted from HANDBOOK OF PROJECT MANAGEMENT © Trevor L Young January 2003
7
Leadership
Team Work
Management

9. • Assumed competency
• Specification (scope) not specific
• What are we doing?
• Who does what and when?
• Lack of individual commitment
• Resistance to change
• “I’ll do it my way” (great song, poor management)
• The feeling that planning is an unnatural act
• “I don’t work like that”
• Over-optimism supported by our keen ability to
underestimate everything
• Bérézina Complex: “We will cross that bridge when
we reach it”
Why Projects Fail? Being Human
8

10. 1. Control scope and manage change
2. Deliver project results on time and on budget
3. Focus the project team on the solution
4. Obtain project buy-in from disparate groups
5. Define the critical path to optimally complete
your project
6. Provide a process for estimating project resources,
time, and costs
7. Communicate project progress, risks, and changes
8. Surface and explore project assumptions
9. Prepare for unexpected project issues
10. Document, transfer, and apply lessons learned from
your projects
Source: http://www.bizmanualz.com
Why Project management?
9

11. 3D Approach to Project Management
Manage
Processes
10

12. Essential elements of Project Management
• Good management
• Effective record keeping
• Good filing practices
• Budget management
• Good communication
• On progress (looking backward)
• On planning (looking forward)
• Good project planning
• Identify critical path & rate limiting activities
• Enable allocation of sufficient time and resources
• Good scenario planning / Risk management
• Go/NoGo decision points
• Be one step ahead of the game
11

13. Project Management
A dynamic action cycle
PHASE 1 PHASE 2
PHASE 4PHASE 3
CONCEPTION & DEFINITION
EXECUTING THE WORK
HANDOVER&CLOSURE
PLANNING&SCHEDULING
DEFINE
OBJECTIVES
PLAN THE WORK
COMMUNICATE
THE PLAN
MONITOR
PROGRESS
REVIEW
& EVALUATE
INSTITUTIONAL
LEARNING
PHASE 0 SELECTION
Opportunities
Identified
Adapted from HANDBOOK OF PROJECT MANAGEMENT
© Trevor L Young January 2003
Redefine
12

14. 13
SC
eGroup
PMG
TMG
• Don’t recycle old management structures
• Identify the needs of the project…
• Bring together people that can contribute to issues
arising in the project through…
• Groups that will meet and communicate regularly.
The Project Management Structure
Research
Stats
Regulator
Finance
Clinical
Database
Admin
Comm.
IP
Research
Regulator
Clinical
Database
IP
Industry
Industry
Contract
Contract Finance
Stats
Strategy
Comm.
Admin
Strategy
Operation

15. The Project Management Group
Principal Investigator
Strategic focus
Project Manager
Operational focus
Project Management Group
Experienced team members
responsible for other roles
PM+PI
(PMG)
Industry
Regulators
Clinical
Researchers
Funder
University
14

16. Choosing a Project Manager
• Appointed and involved at an early stage
• Central point of contact for Project Team and
Stakeholders
• Empowered to do his/her job
• Good organisation skills
• Good communicator
• Flexible, creative, resilient
• Multitasker
• Show initiative – know what (s)he knows and doesn’t
• Think globally, act locally
15

17. Project Planning
• First you need a plan!
• A good project plan should monitor:
• Timelines
• Milestones
• Budget
• Resources
Progress
• Identify critical path / rate limiting activities
• Enable allocation of sufficient time and resources
• Project plans are dynamic - evolve as project develops
• Level of detail will depend on target audience
• The Gantt Chart...
16

18. • A graphical method of showing a project schedule
that shows project time, dates of all activities and
their relationships
• For planning
• For identifying dependencies
• For identifying a Critical Path
• For determining Milestones
• For monitoring
The Gantt Chart
17

19. 18
Gantt Chart - Planning of a Phase I trial

20. From Idea to Phase I - Manufacturing
19

21. Milestones - be SMART
• Specific: objectives should be specific and written in clear,
concise, and understandable terms.
• Measurable: measurable outcomes allow determination of
delivery. Set realistic and justifiable success criteria: Target
value range and acceptable (cut-off) values.
• Achievable: objectives must be aggressive but realistic –
don’t be too ambitious!
• Relevant: tasks and deliverables must focus on progressing
the project along an appropriate (critical) development path.
• Timely (deadlines not durations): objectives should have a
realistic timeframe with an end date assigned to them.
20

22. Be SMART
Objectives (ex: Detection of virus sequences in blood using new qPCR plateform)
• 1. qPCR primer sets capable of amplifying 15 of 16 diverse blood samples
tested with a combination of the assays targeting 3 virus genes using the
fluorescent detection system
• 2. The positive assays will yield a Ct of <10 and the negative control a Ct >38
• 3. The clinical isolates tested will yield Ct below background (sensitivity) and the
correct positive call (specificity) on the Q-PCR platform
21
Success Criteria
1. qPCR primer sets amplifies 15 of 16 diverse blood samples tested with a
combination of the assays targeting 3 virus genes using the fluorescent detection
system.
2. The positive assays yields a Ct <10 and the negative control a Ct >38
3. The clinical isolates tested yields a Ct below background and the correct positive
call on the Q-PCR platform

23. 22
• Example: development of an ultra low viral load assay
• What?
• How?
• Results?
• Variance
• Go/No Go
• What’s next?
Identifying and writing milestones
M Start
Date
End
Date
Month What is
measured?
How is it
measured?
What are the
possible results?
(Go/No go)
Acceptable
variance
What happens
then?
Worded Milestone
1 01/10/12 31/03/13 6 Sensitivity of
UL VL assay
Lab assays <0.2 RNA copy/mL
10%
Proceed to Stage 2
An UL VL assay with a sensitivity
below 0.2 RNA copy/mL has been
developed by Milestone End date>0.2 RNA copy/mL Contract Assay to
Company X.

24. Risk and its management
Project Schedule
Issues
RISKS
Contains inherent…
Which if they
Occur become…
Which if unresolved
impact on…
• Identify & evaluate risks
• Identify risk ownership
• Mitigation
• Prepare a response &
contingency plans
• Continuous process
• Identify early & resolve
promptly
• Constraints # Risks
23

25. • Strategic risks concern long-term strategic objectives of the project. This
type of project risks affects such areas as initial project financing, technology,
reputation, changes in the physical environment, etc.
• Operational risks concern issues and problems that project participants are
confronted with from day to day. Mitigation of operational risks contributes to
reducing of strategic risks.
• Compliance risks concern issues associated with the need to comply the
project course with documented statements and regulations. Managing
compliance risks lets ensure that current project activities are undertaken in the
manner which project stakeholders and customers expect.
• Financial risks are associated with existing financial structure of the project
and with all the transactions made to carry out the project. Identification of
financial risks involves examining daily operations. Financial risks are an
indicator that shows whether current project has serious implications for
viability.
• Knowledge risks are associated with effective management and control of
knowledge resources, communication mechanisms, and protection systems.
Project knowledge risks may include abuse of intellectual property, loss of the
key project staff, system malfunction, etc.
Type of risk and their estimation
24

26. Quantifying risk – Assessing impact
• Probability of occurrence
• Impact on the project
• Decided by team consensus
• Identified at the start
• Added as required
• Reviewed regularly
Impact on the project (conservative matrix)
Low Medium High
Probability
0.65 - 1.00 Medium High
Not
acceptable
0.30 – 0.64 Low High
Not
acceptable
0.0 – 0.29 Low
Medium
High
• HIGH: Major Impact, serious consequences. Likely to affect a Milestone,
must be monitored regularly and closely
• MEDIUM: Significant impact, not expected to affect a Milestone, monitor
regularly
• LOW: Not expected to have a serious impact. Review regularly for ranking
25

27. • Progress
• Risks
• Finance
• Monthly PMG meeting (TMG, SC, eGroup)
• Ad hoc meetings (milestones, finance)
• Quarterly Reports
• Milestones Reports
• End of grant report
• Publications
• Capacity building
• Commercialisation
Project Monitoring & Evaluation
26

28. Good Meeting Management practice
• Schedule regular meetings – with reminders (use Outlook!)
• Request status report (provide template!)
• Circulate agenda in advance – seek input from team members
• Circulate status report and relevant papers (early enough)
• Chair meeting – keep to time (park what needs to be parked)
• Start by reviewing previous Action Points– close completed APs
• Identify issues requiring a decision by whom and when
• Identify Action Points, their owner(s) and a due date
• Circulate minutes/actions for comment within 2-3 days
• Sooner if some actions require immediate action
• Finalise sign-off minutes at next meeting
• Follow up 10 days later
27

29. • When setting budgets consider cost beyond basic
research and clinics
• Travel, publications, samples shipment
• Regulatory support (consultants)
• Regulatory meetings in response to data
• Storage cost IMP (GMP)
• Storage cost samples (short and long term)
• Labelling, packaging, shipping
• Pharmacy (equipment), set up fees (clinical site)
• Ensure grant is set up in your system and that your
finance and admin people know about it
Budget and resources
28

30. Conclusion
• Diversity
• Complexity
• Relationships
• Dependencies
• Stakeholders
 Managing a Project…
…is managing change
29

31. • Trevor L. Young
Young is an expert project management practitioner and his book
provides everything needed to manage a project from start to finish in
a clear, concise and to the point style. Many of the templates I use
are based on his work.
• The Handbook of Project Management: A Practical Guide to
Effective Policies, Techniques and Processes
• Scott Berkun
Berkun’s books are an everyday reminder that tools are as good as
those who use them and that however good they may be, they are no
magic bullet for successful project management. Berkun also debunk
a number of myths about project management and challenges many
management clichés (such as “thinking outside of the box”).
• Julie Warneck Protogenia Consulting Ltd
• Loic Lhuillier Translational Research Portfolio Manager King’s College
London/NIHR BRC
30
Acknowledgement