"The Evidence for Project Management" Please write a paper on the following 2 questions: 1.What can project management bring to clinical research? What evidence is there that effective clinical...

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Module 2
Looking at the Evidence for Clinical Research Project Management
Background and significance
Healthcare industry advancements are based on clinical research
Billions of dollars are invested in the clinical research industry. On average new drug testing and development takes 12 years and costs more than $250 million
Many studies have limited resources to implement a study, and it is crucial to ensure efficient implementation and use of resources
"Every clinical trial is a complex project that requires planning and leadership to be successful."
Parvathaneni, M., Pattarkine M., and Chappidi D. Implementation of Project Management in Clinical Research.  Inventi Rapid Clinical Research, XXXXXXXXXX):1-6, 2017. and Schultz, A. 5 Tips for Successful Project Management in Clinical Research, 2020, Adva
a Forte.
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Why trials fail without PM
How to manage clinical trials hasn't been the focus of much research
Many trials are not successful because of the lack of a structured, practical, businesslike approach to trial management
Many organizations engaged in research have inefficient or non-existent project management processes
This can lead to wasted time, effort, and excess spending
Fa
ell, B., Kenyon, S. & Shakur, H. Managing clinical trials. Trials 11, XXXXXXXXXXhtttps:
doi.org/10.1186/ XXXXXXXXXX
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Key challenges in conducting clinical research
Challenges at all stages of a study – startup, recruitment (big one), data quality, cost, result reporting
Delays from organizations, IRBs, and other oversight committees are well known
50 – 70% of randomized control trials (RCTs) do not meet enrollment goals
Only 13% of RCTs report trials within 1 year of study completion, and only 40% - 50% report at all
Trial results are more likely to be reported if they give positive than negative results (biased reporting) which results in wasted resources
Kaleab Z. et al XXXXXXXXXXCreating an academic organization to efficiently design, conduct, coordinate, and analyze clinical trials: The Center for Clinical Trials & Data Coordination. Contemporary Clinical Trials Communications, Vol. 16, XXXXXXXXXXAnd "The Hidden Side of Clinical Trials, Sile Lane, TEDxMadrid." https:
www.youtube.com/watch?v=-RXrGLolgEc
Top problems in the field
Disorganization
Feasibility, risk assessment, timelines
Sites or PIs new to research
Training needed
Talent shortage
Recruitment and retention of qualified coordinators
Lack of/inefficient local infrastructure
Need to address problem areas and identify solutions
The Top 4 Problems Facing Clinical Research Project Managers (And their Solutions). Fe
uary XXXXXXXXXXPremier Research https:
premier-research.com/perspectives-top-4-problems-facing-clinicl-research-project-managers-solutions
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Comparisons with COVID vaccine rollout
Similar issues have impacted the COVID vaccine rollout in the U.S. and a
oad
Highly effective vaccines
However, slow and inefficient rollout
Systematic inconsistencies and inefficiencies in quality, cost and effectiveness
Why?
Huckman, RS & Staats, B. January 28, 2021. Lessons from the U.S.'s Rocky Vaccine Rollout. Harvard Business Review.
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Vaccine rollout factors
There is a lack of focus on project management in health care generally
Emphasis is more on the technology than on the process and delivery of the technology
Workforce is used inefficiently. Highly trained individuals are often doing tasks that don't require their expertise.
Planning for the final step (distribution of vaccine, in this case) is not as robust. This is a "...deficiency in planning for known unknowns...which is a failure of project management."
Huckman, RS & Staats, B. January 28, 2021. Lessons from the U.S.'s Rocky Vaccine Rollout. Harvard Business Review.
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Lessons from vaccine rollout
In a similar manner, clinical trials act at their peril if they overly focus on the scientific aspect of the study and not the implementation
While the preparations for designing a study and applying for funding are detailed and extensive, planning for implementation is rarely in depth
This may be particularly true for investigator-initiated studies which may not have the benefit of the structure often imposed by sponsored trials
Fa
ell, B., Kenyon, S. & Shakur, H. Managing clinical trials. Trials 11, XXXXXXXXXXhtttps:
doi.org/10.1186/ XXXXXXXXXX
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Lessons from vaccine rollout
Don't fire fight: plan
Define who is responsible for what
Deliver your service or product where the people are at
Employ more frontline workers to get the job done
Huckman, RS & Staats, B. January 28, 2021. Lessons from the U.S.'s Rocky Vaccine Rollout. Harvard Business Review.
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PM and successful trials
"Actively managing every part of the trial is key to success." 
Fa
ell B, Kenyon S, on behalf of the UK Trial Managers' Network: A Guide to Efficient Trial Management. https:
cdn.ymaws.com/www.tmn.ac.uk
esource
esmg
tmn_guide/uktmng2.web.pdf​
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Add a PM to the mix...
Some estimate that 50% of planned trials fail to reach 80% of planned sample size (as an indicator of relative success)
In a comprehensive study of clinical trials, those with a dedicated project manager were much more likely to successfully recruit participants
 Fa
ell, B., Kenyon, S. & Shakur, H. Managing clinical trials. Trials 11, XXXXXXXXXXhtttps:
doi.org/10.1186/ XXXXXXXXXX
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The PM factor: PRINCE2 Case Study
UK investigators tested whether a widely used project management method could be effectively applied to the management of phase III clinical trials
The study found clear benefits of project management when used with clinical research studies
Gist, P & Langley, D. Application of Standard Project Management Tools to Research - A Case Study from a Multi-national Clinical Trial. November 2, 2007. The Journal of Research Administration, Volume 38, p XXXXXXXXXX.
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PRINCE2 Case Study
Key elements of the project management approach included:
Clear project aims
Defined and measurable sets of activities and results
Defined resources
Defined roles and responsibilities
Documents included that led to success:
A document to summarize in one place the aims, project plan, key deliverables, resources and budgets, key dependencies, governance structure, risks, and change control procedures
Detailed project plan
Financial controls and reporting procedures
Risk register and issues log
Gist, P & Langley, D. Application of Standard Project Management Tools to Research - A Case Study from a Multi-national Clinical Trial. November 2, 2007. The Journal of Research Administration, Volume 38, p XXXXXXXXXX.
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PRINCE2 Case Study
Other important elements investigators thought would include:
People management techniques
Planning tools
Budget management methods
Benefits of project management included:
Time savings
Clarity for team members through standardization of work activities
Better financial management
Improved relationship with funders
Better audit trail
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PRINCE2 Case Study
Tools, terminology, methods were new to those involved and required a steep learning curve
Many investigators need to be convinced of the benefits of project manager in order to accept the costs
However GCP, FDA etc. require high quality data collection, management, processes; and high quality project management is one way to ensure that
PM is becoming increasingly important as the complexity and numbers of trials increases
Gist, P & Langley, D. Application of Standard Project Management Tools to Research - A Case Study from a Multi-national Clinical Trial. November 2, 2007. The Journal of Research Administration, Volume 38, p XXXXXXXXXX.
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What is the cost benefit ratio of a PM?
Do project management tools help or hinder the management of clinical trials?
Do they place undue administrative burden on the trials?
What are the benefits of PM for clinical trials?
How can we justify the costs for project management in a clinical trial?
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Cost benefit ratio of a PM evidence
A comprehensive literature review of published studies over a 10-year period
Successful trials had a trial manager who developed a work plan or work scope and a timeline 
Project management reduced waste and improved trial implementation
Goodarzynejad H. & Babamahmoodi A. Project management of randomized clinical trials: A na
ative review. Iran Red Crescent Med. J. 2015 Aug: 17(8): e11602
Project management effectiveness evidence
Leadership, negotiation, and communication skills result in improved project deliverables, patient recruitment, and regulatory compliance.
A poorly managed clinical trial can result in increased costs and delays to product approval
Many clinical trials fail because they lack a structured, practical, businesslike approach to trial management
Many see good project management as the cornerstone of success
Investing in project management upfront can increase the efficiency of the study and in the end reduce overall costs
Goodarzynejad H. & Babamahmoodi A. Project management of randomized clinical trials: A na
ative review. Iran Red Crescent Med. J. 2015 Aug: 17(8): e11602

Chapter 1 - Foundational Elements and Regulatory Requirements
The Sourcebook for Clinical Research. https:
doi.org/10.1016/B XXXXXXXXXX00001-1
© 2018 Natasha Martien and Jeff Nelligan. Published by Elsevier Inc. All Rights Reserved.
CHAPTER
1
1FOUNDATIONAL ELEMENTS AND REGULATORY REQUIREMENTS
Purpose of chapter:
• Describes the purpose of medical research
• Defines the Types of Research Studies
• Provides the definition of a Clinical Trial
• Explains how a Clinical Trial differs from Clinical Research
• Provides overview of Mandatory Regulations and Ethical Guidelines for Use in Clinical
Research: Code of Federal Regulations and ICH GCP (International Council for Harmonisation
Good Clinical Practice)
a. Explains FDA versus HHS regulations
• Describes How to Secure a Clinical Trial and Market your Medical Facility to Sponsors
• Explains Principal Investigator Responsibilities
• Explains Research Coordinator Responsibilities
• Describes the Role of HIPAA and PHI in Clinical Research
1.1 WHAT IS THE PURPOSE OF MEDICAL RESEARCH?
Purpose of section:
• Explains why medical research is conducted
Clinical studies are designed to add to medical knowledge related to the treatment, diagnosis, and
prevention of diseases or conditions. Some common reasons for conducting clinical studies include:
• Evaluating one or more interventions (for example, drugs, medical devices, approaches to surgery
or radiation therapy) for treating a disease, syndrome, or condition;
• Discovering ways to prevent the initial development or recu
ence of a disease or condition;
• Evaluating one or more interventions aimed at identifying or diagnosing a particular disease or
condition;
• Examining methods for identifying a condition or the risk factors for that condition, and,
• Exploring and measuring ways to improve the comfort and quality of life through supportive care
for people with a chronic illness.1
In these textbook-like bullet points, however, the heart and soul of why we conduct studies is not
truly conveyed. When you are working in a hospital and see the pain in a patient’s eyes, see their family
grieving and anxious, or a child in a wheelchair with a shaved head, you want to do anything you can
2 THE SOURCEBOOK FOR CLINICAL RESEARCH
to help. You want to find a cure for what afflicts the people in your care. You want to relieve a family of
its burdens. When you see up close this suffering and anxiety, it becomes very easy to understand why
medical research is conducted: to find relief or better treatments, so that people can lead a better quality
of life or so they can continue to live.
1.2 DEFINING THE TYPES OF RESEARCH STUDIES
Purpose of section: