Project Management in Clinical Trials. Presented by: Melanie Gentgall and Tim Dyke

Transcription

1 Project Management in Clinical Trials Presented by: Melanie Gentgall and Tim Dyke

2 We acknowledge the traditional custodians of the land on which we meet today, and pay respect to their elders past, present and future.

3 About Praxis Global Reconciliation Founded in April 2015, PRAXIS is an independent NFP/charity, created as a collaborative social enterprise by its member organisations.

4 Research Essentials

5 Housekeeping

6 Today s Workshop

7 In a clinical trials context What is a project? What is project management? How do I manage planning? risk? time? resources? budget? quality? myself?

8 Introductions

9 Introductions 1.Your name and role 2.What do you want to get out of today?

10 What you ll learn What it takes to manage a project within a CT context Key issues and tools Handy hints Taking away an action list

11 What is a Project? A project is a temporary endeavor undertaken to create a unique product, service, or result. The temporary nature of projects indicates that a project has a definite beginning and end. The end is reached when the project s objectives have been achieved. PMBOK, 5th Edition, Chapter 1, Section 1.2, p3

12 Project Scope

13 What is Project Scope? Scope is a statement that defines the activity which include the features, functionality and boundaries of the project, such as: o Time o Resources o Cost o Quality o Risks

14 What is Scope Creep? Scope creep when new provisions, tasks, or unexpected deliverables outside of an existing scope of work are added to a project can lead to missed deadlines, overrun budgets, and client dissatisfaction. The PMBOK Guide describes scope creep as adding features and functionality (project scope) without addressing the effects on time, costs, and resources, or without customer approval (PMI, 2008, p 440).

15 Group discussion Who has experienced scope creep? How did you manage this? What did you learn that you can use in your next project?

16 Managing scope creep 1. Well-defined project scope (accurate project requirements) 2. Clear and measurable objectives (a project plan outlining the work with milestones and metrics) 3. Communicate the impact of scope creep (learn how to say no, postpone changes to a later date) 4. Project kick-off meeting (establish roles and responsibilities and a process for regular check-ins) 5. Accept that some change is inevitable and be prepared for it (have a change sign off process, contingency plan and budgeting for any extra resources needed) 6. Ensure you estimate your costs accurately to ensure adequate resourcing

17 What is Project Management?

18 What is Project Management? The application of knowledge, skills, tools and techniques to project activities to meet the project requirements. Project Management Institute Project Management Institute [2018] [cited 2016 June 4].

19 5 Phases of PM

20 Project Management Approaches Traditional, linear project approaches (e.g. PMBOK, PRINCE2, MS Project) Complex adaptive (e.g. Agile)

21 Role of the Project Manager The Project Manager executes the Project according to the plan (in most cases this means the study protocol). The Project Manager continuously manages and evaluates the overall project performance to provide confidence that the project will satisfy the relevant quality and other standards.

22 Skills for success Excellent communicator: clearly and effectively Organised and systematic Ethical: The PM sets the standard for the team Enthusiastic: Can motivate the team Problem solver: Resourceful and creative Cool and collected Delegator and Escalator Competent The project manager is the link between strategy and execution One of the most common reasons clinical trials fail is unskilled project managers.

23 Activity 1: 5 Phases of PM

24 Instructions: Activity 1 1. You will be assigned a number that corresponds to one of the 5 PM Phases: 1. Initiating 2. Planning 3. Executing (implementing) 4. Monitoring and Controlling 5. Closing 2. Using the post-it notes on your table: Write down as many CT tasks as you can think of that relate to that phase Write one task per sticky note Write as many tasks as you like! 3. When you are done, find the butchers paper on the wall for your assigned phase and stick on the tasks you have written down. Don t return to your seat just yet!

25 5 Phases Overlapping Nature

26 Project Plan Excel spreadsheet One tab for each PM phase and include the table below TASK/MILESTONE TIMEFRAME BUDGET RESPONSIBILITY WHAT? WHEN? HOW MUCH? WHO? Gantt chart/month Estimates Who in your project will manage this?

27 Stakeholder Roles, Responsibilities and Relationships

28 Who is a Project Stakeholder? An individual, group or organisation, who may affect, be affected by, or perceive itself to be affected by a decision, activity or outcome of a project Project Management Institute (2013) A guide to the Project Management Body of Knowledge (PMBOK Guide, 5th Edition)

29 Why are stakeholders important? Engagement of key stakeholder groups is critical across the research continuum, from making sure the right questions are asked to ensuring that study findings make it into the hands of health and healthcare decision-makers. Stakeholders are integral to project success and execution. Some will be more important than others and play bigger roles. It s also important to know who are key to the project to help to plan communications.

30 Clinical Trials Stakeholder Hierarchy Stakeholder Responsibilities 1. Vision and accountability Setting vision, objectives, aligning activity with strategy, approvals 2. Leadership Project leadership, compliance, management of risks 3. Management Manage resources, scheduling, communication, overall delivery 4. Implementation Day to day project activity (recruitment, data collection and analysis, reporting)

31 Stakeholder Mapping

32 Communicating with Stakeholders The stakeholder engagement and communication plan contains your strategies according to each unique stakeholder for your project The engagement and communication plan is where you ll plan consultations, identify communication methods, list the audience for each engagement, the frequency of communications, and the tools you will use to efficiently implement your strategy. It s important to keep in mind the project lifecycle as you plan communications, as some steps require more engagement than others.

33 Activity 2: Communicating with stakeholders

34 Instructions: Activity 2 Stakeholder Engagement and Communication Plan 1. Working with others on your table fill in the Stakeholder Engagement and Communication Plan. 2. Select a current project stakeholder one of you are having difficulty managing and use them as your example. Note: You will find a copy of a plan to fill in at each table.

35 Example: Stakeholder Engagement/Communication Plan Stakeholder Area of influence Project Phase Stakeholder Manager Engagement approach Engagement focus Frequency HREC Research Governance Planning, Execution, Control, Close Research Manager Principal Investigator Consultation and communication Electronic Submission of application correspondence Consult: Prior to ethics submission Communicate: as necessary Meetings in person as required Safety Reporting Annual and other reporting Amendments Sponsor Research Funder All phases Principal Investigator Research Manager Research Staff Consultation and communication correspondence Meetings in person as required TC/Video link Site verification Site start up Site monitoring Site close out Remote Monitoring Trial Participants Consumers and the general public All phases Principal Investigator Research Manager Consultation and communication Advertising Recruitment campaigns At study concept planning Recruitment phase Research Staff Public Forums Patient/Disease Advocacy Group meetings Social Media During study conduct (seek feedback on experience) Between visits Post close out

36 Communication Formal communication o Scheduled project team and management meetings o Scheduled touch base meetings with relevant stakeholders (e.g. site managers, suppliers, trial partners) o Reporting to Steering and advisory committees o Formal reporting in accordance with guidelines Informal communication o Day to day communication with project team members o Responding to changes in situations o Communicating with trial participants

37 Example: Project Progress report

38 Risk Management

39 Risk Management Risk: something that might happen that will have an impact, either positively or negatively, on the project. Risk management concepts can be extracted from the ISO 14971: Risk Management for Medical Devices and ICH Q9: Quality Risk Management. The basic steps to risk management include: 1. Identify and assess risks, 2. Mitigate risks, and 3. Review risks. Additional steps that are required throughout the process include communication of risks and documentation activities

40 Creating a Risk Register: 5 Steps Step 1: Identify the risk Step 2: Analyse the risk Step 3: Evaluate or rank the risk Step 4: Treat the risk Step 5: Monitor and review the risk

41 Example: Risk Management Matrix

42 Common Risks in Clinical Trials Lack of training: When organizations devote resources to ongoing project management training, offer a defined project management career path, and establish formal knowledge transfer processes, 32 percent more projects are successful. Lack of resources: Lack of resources affects projects across the board, including at the subproject level. A smart organization and project manager look at resources regularly.

43 Common Risks in Clinical Trials Poor planning: Preparation and planning is important to save time and money throughout a clinical trial. The team should create a plan and contingency plans, consider all the things that could go wrong (risks) and a plan to mitigate or respond to the risks. Unrealistic timelines Lack of standardised project management techniques and tools Poor time management

44 Activity 3: Risk Registers

45 CREATE A RISK REGISTER Individual Activity USE THE TEMPLATE PROVIDED ON YOUR DESK AND FILL IN FOR ONE OF THE MAJOR RISKS YOU ENCOUNTER IN YOUR PROJECTS. It might include things like : Budget shortfall Staff not competent in performing expected roles Low participant recruitment Recurrent protocol violations Third party providers not providing the services as agreed

46 Activity 4: Root Cause Analysis and CAPA

47 Root cause analysis When people discover problems, the most frequent response is to rush to find a solution. Unfortunately, it is not the best way to solve a problem as it leads to the need to solve the same problem over and over again. A better approach is to eliminate the root cause.

48 The 5 Whys This approach is most useful for problems which involve human factors or interactions. By repeatedly asking the question 'Why?' (five is a good rule of thumb), you can peel away the layers of symptoms which can lead to the root cause of a problem.

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50 Instructions: Activity 4 Your table will be assigned a Problem Statement #. Keep this number in mind. Start by reading the first page of your Activity Handout. 1. The 5 whys a method of conducting Root Cause Analysis 2. A simple example of the 5 whys method Then turn over and read the trial scenario provided 1. Working with members of your table use the 5 Whys template provided to conduct a root cause analysis of your assigned problem statement (#1 or 2) 2. Once you have reached a final root cause to the problems statement, use this finding ( your final answer in the 5 why activity) to complete a CAPA plan. The template is on your table. 3. We will ask you to report your findings back to the whole group

51 Time management

52 Activity 5: How long is 30 secs?

53 Eisenhower Matrix: Prioritising What is important is seldom urgent and what is urgent is seldom important. Dwight Eisenhower

54 Planning and Prioritising Quantify tasks & time (how long will each task take?) Prioritise (know the difference between urgent and important) Create a time map for your week (map your time 168 hour week and 24 hour day)

55 Management Schedule response times in your day Turn off your alerts Move away from your desk Move non-critical items into a To-Do file Move items into your task list and set reminders Use tools such as Clean Up to remove duplicate threads in your inbox

56 management cont Use rules to ensure you only see what is necessary Create Quick Parts for Default Responses to Common Questions When you are confident with using these new tools use Quick Steps

57 Budget Management These are essential documents you will need to plan your budget they will ensure you have all the variables you need to fully cost a study. Other useful documents include: visit schemas, 3 rd party agreements, IHPA pricing

58 Non industry sponsored trials If your project budget is required to support a grant application to an external funding body such as the NHMRC or ARC, you will need to gather information about the institutional requirements. Most tertiary academic institutions have excellent templates and guides for students and researchers to assist in budget planning. They also commonly provide in person support so find out what is available, what is necessary and then make the most of the available resources.

59 Quality Management

60 What is Quality Management in Clinical Trials? Quality in clinical trials may be defined as the absence of errors that matter.

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62 So what can you start doing today at your site? Understand your context Get buy in from your leadership Bring your team on board Look at your current policies and processes and find the gaps 1. Review your current SOPs and update look at available resources don t re-create the wheel ask for help from colleagues and share resources 2. Start out in the way you plan to finish start implementing project management strategies 3. Include risk identification and management strategies at the very least 4. Improve your communication strategy with all stakeholders

63 Monitoring and controlling as part of quality management

64 Monitoring and Controlling Tracking milestones Tracking tasks Monitoring scope Meeting schedules/timelines Reporting schedules/timelines Useful software tools include:

65 Escalating issues Red and Amber Flags

66 Staying on track Understand the objective/outcome of the project, its scope and all deliverables Know the team members and ensure they know their roles Allow people to do their job don t micromanage Communicate effectively with stakeholders Use standardised PM tools and techniques Understand where risks lie and address them proactively where possible Manage time, resources and yourself Estimate budgets as accurately as you can Ensure quality including through control and monitoring, reporting and escalating Enable a good experience for the client

67 Managing myself

68 Managing myself and my energy Reflection - Designate my time to reflect and learn as urgent and important at least once a week Focus - on one thing at a time and give it time Re-energise - give yourself presence and permission to pursue personal interests hobbies etc

69 Wrap up

70 In a Clinical Trials context What is a project? What is project management? How do I manage planning? risk? time? resources? budget? quality? myself?

71 Questions Have we been able to cover your original agenda? What is one PM technique or tool that you have learned about today that you will use in the future? What are your action items?

72 Thank you

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