Leadership and Management of Clinical Trials in Creative Arts Therapy

This book focuses on leadership and management strategies including project management, budget planning and management, governance, building a team, and developing a strategy for successful recruitment. Many creative arts therapy researchers lack training and experience in designing and implementing large scale high impact clinical trials. This book is the first in the creative arts therapies that provides guidance on clinical trial implementation. Data management, monitoring, and intervention fidelity and development of a statistical analysis plan are outlined. Finally, the text explores development of a dissemination plan as well as how to commercialise research. Foreword Preface Acknowledgements Contents About the Author List of Figures List of Tables 1 Introduction Implementing Robust Creative Arts Therapies Trials Sharing Wisdom and Capacity Building So You Won The Grant, Now What? Past and Current Projects Study 1. Music Therapy to Aid Non-invasive Ventilation Transition for People with Motor Neuron Disease (2014–2015) Study 2. Singing My Story: Negotiating Identities Through Therapeutic Songwriting for People with Neurological Injuries (2015–2017) Study 3. MIDDEL: Music Interventions for Dementia and Depression in Elderly Care—The Australian Cohort (2017–2022) Study 4. HOMESIDE: Home-Based Caregiver Delivered Music Interventions for People Living with Dementia (2019–2022) Study 5. MATCH: Music Attuned Technology for Care via eHealth (2020–2025) Study 6. MAPS: Music and Psychology and Social Connections Program (2021–2022) Scope of the Text References 2 The Scope of Project Management How Out of Control Can a Controlled Trial Be? The Project Management Plan Five Phases of Clinical Trial Project Management Successful Management Approaches Good Communication Is Like the Oil in Your Engine Avoid Meeting Madness Documentation Avoids Miscommunication What’s Happening Today: Calendar Management Accountability Problem Identification and Resolution Essential Clinical Trial Documents Study Protocol Manual of Operational Procedures Case Report Forms Clinical Site Management Plan Risk Management Plan Developing a Risk Assessment Plan Types of Risks in Trials Common Challenges in Clinical Trial Execution Balancing Complex Workloads Budget Constraints Poorly Planned Timelines Poor Task Prioritisation Conclusion References 3 The Art of Good Governance What Is Governance? Governance at Project Design Stage Governance at Project Authorisation Stage Governance at Project Implementation Stage and Project Closure Project Governance Committees Trial Management Group Trial Steering Committee Data Safety Monitoring Board Project Operational Committees Whole Team Meetings Smaller Working Groups and Workstreams Capacity Building Committee Statistical Analysis Plan Team Public and Patient Involvement Committee Frameworks of PPI Components of PPI Participation Reasons the Public Get Involved Establishing and Implementing a PPI Conclusion References 4 Assembling and Uniting a Team Staffing to Your Needs Principal Investigator Project Manager Clinical Trial Manager Biostatistician Health Economist Information Scientist Data Manager Other Team Members Optimising Performance: A We-ness Culture Empowering the Team Safety Within the Group Leading the Team Conclusion References 5 Budgeting for Success: Management and Resource Planning Barriers and Enablers to Effective Resource Management Preparing a Study Budget Project Design and Set-Up Project Implementation Models to Budget for Recruitment Licensing Fees Using Routinely Collected Data Trial Site Visits and Monitoring Governance Costs Data Management and Analysis Project Management Public and Patient Involvement and Public Engagement Knowledge Translation and Exchange, Public Engagement, and Advocacy Conclusion References 6 Recruitment, Retention, and Follow-Up: Frustration or Bliss Introduction Why Do People Choose to Participate in Research? Why Do People Decline Participation in Research? Health Status and Stigma Scepticism, Fear and Mistrust Family Factors Language Barriers Participant Burden Developing and Monitoring the Recruitment Strategy Participants Developing the Research Promotional Product Promoting the Study Price Working with Industry Partners Involvement of Public and Patients in Recruitment Strategies to Improve Conversion Rates Harness Trust Supporting Decision Making Minimise Burden of Participation Offering Appropriate Incentives Working with Your Recruitment Team Barriers to Participant Retention and Follow-Up Factors to Increase Retention Motivating the Recruitment Team Conclusion References 7 Quality Data Is Power: Data Management and Monitoring The Need for Good Data Management and Monitoring Defining Quality Data Levels of Data Monitoring The Data Management Plan (DMP) Systems for Data Collection and Management Type of Data and Measures Data Collection Methods Data Entry Data Security Data Cleaning and Quality Control Case Report Forms Data Access: Roles and Responsibilities Data Storage Study Participant Monitoring Data Sharing and Long-Term Preservation Monitoring and Reporting Developing an Electronic Data Capture System for Your Trial Overview of the EDC System Development Process Database User Interface Conclusion References 8 Development, Measurement, and Validation of Intervention Fidelity What Is Fidelity and Why Is It Important? Reporting of Intervention Fidelity in Creative Arts Therapies Literature Conceptual Frameworks of Fidelity Intervention Adherence Assessment of Intervention Components Strategies to Safeguard the Quality of Intervention Delivery Creative Arts Therapist Competence and Training Intervention Supervision and Monitoring Methods of Monitoring Adherence and Exposure Treatment Receipt Treatment Differentiation Treatment Enactment Conclusion References 9 Statistical Analysis Plan What Is a Statistical Analysis Plan? Why Does a Trial Need a Statistical Analysis Plan? Developing a Statistical Analysis Plan Statistical Analysis Plan for Observational Studies Missing Data Approaches to Treat Missing Data References 10 Development of a Knowledge Translation and Exchange Plan Our Ethical Responsibility to Disseminate What Is and Why Implement Knowledge Translation and Exchange? Dissemination Development Plan Research Findings and Products Identify End-Users Collaborating with Partners for Dissemination Communicating Your Message Evaluation of Your Dissemination Plan Strategies and Considerations for Implementing KTE Authorship and Publishing Publication Bias Conclusion References 11 Innovation, Intellectual Property, and Commercialisation Innovation Intellectual Property—Copyright, Patents, Trademarks, and Secrets Establishing IP Asset Segments Is Commercialisation a Dirty Word? Commercialising the Creative Arts Therapies Engaging with the Business Development Departments at Universities Assessing Commercial Potential of Your IP Product Development Step 1. Translation of IP into a Proof of Concept Step 2. Conceptual Design and Development of Low-Fidelity Prototype Step 3. Iterative Design and Evaluation of High-Fidelity Prototype Step 4. Production and Testing of Minimal Viable Product Business Development Competitors Paths to Commercialisation Collaborating with Industry Confidentiality Agreements Establishing a New Arm of Your Team A Word of Caution About Commercialisation Conclusion References Index