2019 Interactive Breakout Discussions

Interactive Breakout Discussion Groups

Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become an active part of the discussion at hand. Bring your pharma, biotech, CRO, site, hospital or patient perspective to each of the discussions below. To get the most out of this interactive session and format please come prepared to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing.

This year due to positive feedback we will be running two breakout discussion sessions, one on Tuesday afternoon and a second on Wednesday afternoon. Attendees will thus have a chance to join two topic discussions.

We are developing the breakout discussion topics now and are open to suggestions! The 2018 list is below to offer examples.

TABLE 1: What Is Holding Back the Adoption of eConsent?

  • Is eConsent for every trial? Discuss when eConsent is or isn’t appropriate
  • Understand IRB and regulatory feedback on the eConsent process
  • Discuss how eConsent technology integrates with other systems
  • Review a typical implementation timeline and how it impacts all stakeholders

TABLE 2: Leverage RWD to Optimize Protocol Design, Reduce Protocol Amendments, Accelerate Recruitment and Increase Patient Centricity – A European Perspective

  • What are the updated metrics on the prevalence and causes of protocol amendments and trial/recruitment delays and what does this mean for us?
  • How can we as an industry leverage RWD to improve the process of protocol design and recruitment?
  • What are some community initiatives and individual company approaches to finding success?
  • What’s in it for the sponsor, the investigator and ultimately the patient (in protocol design, reduction of amendments, accelerating recruitment, increasing patient centricity)?

TABLE 3: Strategies for Accelerating Recruitment in Complex Clinical Trials in a Resource Constrained Environment

  • Dealing with the Acute Patient where timing is critical
  • Do traditional/past tactics still work in current environment? What tactics (new and old) work best today?
  • Ensuring success for procedure driven protocols (non-conventional administration, device and/or diagnostic intense)
  • Utilization of supportive field resources to accelerate recruitment (caregivers, Medical Science Liaisons, Clinical Trial Educators)

TABLE 4: Optimizing Country and Site Selection: Strategies for Positioning Trials for Success Using a Global Footprint

  • Optimizing the site feasibility process: Improving global site feasibility assessment to identify sites that will recruit on time and within budget
  • Objective country feasibility and selection: Where are the patients?
  • Data-driven site selection: Understand the number of sites, their probability of success, and the impact of site non-performance

TABLE 5: Improving Both Time and Quality in Site Activation and Study Start-Up (Sponsor, CRO and Site Perspectives)

  • Identifying and consolidating site start up activities that are redundant, inefficient and needlessly complex
  • What are key learnings and opportunities for different approaches, including a centralized approach of study activation and site performance?
  • How can sponsors, CROs and site streamline site activation and study start-up?

TABLE 6: Strategies for Patient-Centric Trial Design and Digital Patient Engagement

  • What are current digital patient projects gaining traction, engagement pilots, new technologies, the role of patient communities?
  • What is a complete digital patient experience? What is required to make this a reality for all trials?
  • What are we getting right and what are we getting wrong as we realign our processes and our research organizations around the patient-centric model?

TABLE 7: RBM in a Finance and Resource Limited Environment

  • How can we adopt TransCelerate’s RACT model for a resource limited company/organization?
  • In terms of technology, what are nice to haves vs. need to haves for implementing RBM?
  • Who is involved in putting RBM in action at smaller companies?

TABLE 8: Centralized Monitoring

  • Common misconceptions about centralized monitoring
  • What are the tech needs to implementing centralized monitoring?
  • Best practices and lessons learned from those using centralized monitoring

TABLE 9: The Impact of Final ICH GCP E6 Guideline and R2 Addendum in Globalization Environment: Changes Affecting Sponsors, CROs, Clinical Investigators, Sites

  • Describe the E6 R2 terms that are new/updated
  • Identify the changes impacting investigators, sites, Sponsors, and CROs for budgeting and contract development and execution
  • Explain the impact of the revisions on clinical trials conduct and organizational practices
  • Evaluate solutions for applicability/modification of organizational processes, procedures for forecasting, budgeting and costs estimation
  • Apply lessons learned for effective implementation of the new ICH GCP E6 R2 guideline

TABLE 10: Implications of Sourcing Model on Financial and Resource Budgeting

  • Choosing a sourcing model to complement your portfolio strategy, and its implication on internal and external sourcing
  • Approaches for accurately forecasting financial and resource demands
  • Quantitative and qualitative considerations for adapting resources and budgets for a particular sourcing model

TABLE 11: Advanced Analytics and Artificial Intelligence in Clinical Trials

  • Will data science and machine learning disrupt the provision of clinical evidence or compliment it?
  • With Machine Learning becoming needing Big data sets, how could the industry share more data in a precompetitive framework?
  • As more Deep learning techniques are deployed - how can we gain confidence in “Black Box” approaches?
  • In what ways, if any, will we have to change how we work with regulators?

TABLE 12: Wearable Devices in Clinical Trials

  • What is the value, beyond scientific interest?
  • Where do we want to be in 5 years (and why we are not there already!)?
  • Key challenges for industry uptake?
  • Opportunities for industry-wide collaborations

TABLE 13: Impact of the Delays Regarding the Application of the New EU-CTR (EU-Regulation 536/2014)

  • What is the current implementation status of the EU-CTR (EU-Regulation 536/2014)?
  • What are the consequences of these delays for Europe as a clinical trial location?
  • How should organizations prepare for various outcomes/timelines?