Outsourcing in Clinical Trials Southeast 2022

Chairperson, Kevin Crawford

• Understand the importance of diversity in patient population in order to widen your participants demographic, including a historical review
• Fostering methods that reach patients from various backgrounds and implementing principles of health literacy in clinical trials
• Designing trials that appeal to a wider patient population and adopting a patient centric approach to establish relationships with communities
• Using decentralized trials as an environment where patients can participate comfortably without being required to physically be on site

• Looking at a case study of the Beat AML® Master Clinical Trial, a clinical trial that simultaneously uses multiple therapies in multiple study arms
• Exploring how the Beat AML® has the power to bring new therapies to AML patients faster and identifies each patient cancer-driving genetic mutations
• Navigating the shift to innovation and digital approaches in clinical research since COVID -19 and evaluating the challenges including examples of AI and remote monitoring
• Understanding how the current different technological trends can work in existing clinical trial processes and structures
• Investigating the regulatory pathways and potential limitations when implementing technology changes

• Exploring the remote monitoring activity triggered by specific study visits or events to promote real time data entry cleaning and standardization in clinical trials
• Looking at the importance of the process when updating manual and automatic edit checks to promote quality including examples
• Understanding how ongoing and real time review serves as a platform for educating CROS on therapeutic areas
• Utilizing the activity process when cleaning data throughout the trial rather than waiting till the end of the study or another study lock using examples of interim analysis

• Determining how a CRO- sponsor relationship can boost the effectiveness of the trial
• Ensuring initial contact is clear and concise with CROs, to confirm the project specifications and deadline requirements
• Exploring effective techniques for enrolment and retention when working with a CRO and implementing consistent KPI’s
• Unlocking strategies to manage vendor and trial sponsor teams under one shared goal
• Looking at methods to get back on course when commitments are not being met and rebuilding site relationships

• Overcoming data collection inaccuracy with decentralized trials and ensuring patient data is not being fabricated
• Implementing decentralized trials that are cost effective and align with the patient journey
• Addressing the gaps in technology when it comes to achieving paperless trials
• Exploring if the ‘shift’ to decentralized trials has distracted focus from other emerging technology: has other innovation been ignored?

• Unlocking effective techniques to help team members fulfil timelines and control the standards and costs of trials
• Optimizing engagement by using a more personal approach of communicating in order to foster strong team relations
• Highlighting the importance of strong leadership in order to achieve clinical trial corporate and personal goals
• Understanding the importance of collaboration at all levels to outline team members importance and welcome innovation

• Investigating the various methods of funding to establish the most suitable avenue and navigating strategies to showcase aspects of your trial that will distinguish your proposal from the rest
• Examining frequent hurdles to acquire funding and how to overcome these and looking at the appeals process if a grant has been denied
• Establishing the best practices in applying for grants when receiving conflicting feedback from the FDA and review board
• Addressing the pre-clinical conversations in early-stage clinical trials: how early should you start to look for CROs?

• Presenting a case study of AAV dosing platform that addresses the challenges when delivering viral targeted therapies
• Looking at machine learning to improve targeted delivery and assist with meeting regulatory requirements
• Utilizing facilities that meet the regulatory standards of the FDA and ICH
• Highlighting the focus of risk-based approaches in clinical development programmes
• Navigating methods to work effectively with sites and CROs and to maintain relationships and ease pressure

• Utilizing decentralised trials to ease financial burden and risks on patients
• Developing techniques to stand out from the crowd, when competing with other trial sponsors
• Building relationships with smaller patient population in order to increase patient enrolment
• Unlocking new methods of engagement using apps and websites to strengthen patient engagement

• Looking at the prime learnings from handling a clinical trial through the restrictions of COVID 19 and understanding how to transform these learnings into the current environment
• Establishing the long-term implications of COVID 19 on staff resources and patient recruitment and retention
• Understanding the importance of incorporating flexibility and patient centricity from the start and balancing the implications of participants and staff becoming infected
• Exploring the shift that the pandemic encouraged to new innovative technology shaping the industry

• Understanding how blockchain provides data confidence for AI putting trust in a system, and ensuring data cannot be changed
• Evaluating how blockchain can streamline supply chains
• Using Blockchain in the personalization of medicine and organisation of patient’s information
• Looking to the future of blockchain technology; what can we expect in the next 10 years?

• Exploring the Electronic Common Technical Document (eCTD) when submitting applications, amendments and reports to the FDA’s Centre for Biologics Evaluation and Research
• Navigating the Regulatory Information Management System (RIMS) and highlighting the importance of 21 CFR requirements when creating, using, and maintaining electronic records
• Exploring best regulatory practices when selecting US and global clinical sites and understanding the best methods in clinical development planning.
• Looking at the rise of trust and transparency in clinical trials and unlocking the key considerations and navigating trials globally

• Navigating current methods used with the increasingly popular hybrid home health approach
• Reducing the burden and risk of patients by fostering home visits, in order to boost patient retention
• Utilizing the hybrid approach to provide a personalised patient service and recruit more patients
• Addressing patient concerns with home health services – do participants want health care professionals visiting there homes?
• Looking to home health in clinical trials to address data inaccuracy in decentralized trials

• Exploring the background of gene therapy by looking at previous gene therapy trials and the reason for a recent uptake
• Evaluating and choosing the optimum trial design for targeted therapies
• Understanding the importance biomarkers and companion diagnostics play in the development of targeted therapies
• Looking at the FDA’s rising predictions of gene therapy by 2025 and navigating the possible future implications