"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 research project management can
lead to success in clinical trials?
2. What other factors may impact the success of a study team in
implementing clinical research?
Resources
attached need to be used:
PowerPoint Presentation 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, 2018 (1):1-6, 2017. and Schultz, A. 5 Tips for Successful Project Management in Clinical Research, 2020, Advarra Forte. 2 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 Farrell, B., Kenyon, S. & Shakur, H. Managing clinical trials. Trials 11, 78 (2010). htttps://doi.org/10.1186/1745-6215-11-78 3 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. 2019. Creating 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, 100488. And "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). February 9. 2017. Premier Research https://premier-research.com/perspectives-top-4-problems-facing-clinicl-research-project-managers-solutions/ 5 Comparisons with COVID vaccine rollout Similar issues have impacted the COVID vaccine rollout in the U.S. and abroad 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. 6 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. 7 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 Farrell, B., Kenyon, S. & Shakur, H. Managing clinical trials. Trials 11, 78 (2010). htttps://doi.org/10.1186/1745-6215-11-78 8 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. 9 PM and successful trials "Actively managing every part of the trial is key to success." Farrell 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/resource/resmgr/tmn_guide/uktmng2.web.pdf 10 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 Farrell, B., Kenyon, S. & Shakur, H. Managing clinical trials. Trials 11, 78 (2010). htttps://doi.org/10.1186/1745-6215-11-78 11 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. 51 - 58. 12 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. 51 - 58. 13 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 14 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. 51 - 58. 15 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? 16 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 narrative 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 narrative 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/B978-0-12-816242-2.00001-1 © 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 recurrence 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: