Synergy I Forum 

The Inaugural ACRES Synergy Event

The Alliance for Clinical Research Excellence and Safety (ACRES) proudly hosted its pioneering Synergy event in Boston, MA, on October 1st and 2nd, 2015. This landmark gathering was designed to ignite a global transformation in clinical research, laying the groundwork for a more efficient, patient-centric, and trustworthy future.

A Convergence of Global Thought Leaders

The Synergy event brought together an influential group of thought leaders from a wide spectrum of clinical research stakeholder organizations from across the globe. These included visionary keynoters, insightful panelists, and engaged participants. The deliberately designed format fostered an environment where all participants, including those courageous enough to share "failure" stories, felt safe and empowered to engage openly.

Dynamic Dialogue and Shared Insights

Day 1: Embracing Systems and Systems Thinking Approaches 

The first day set the stage for applying Systems Thinking to clinical research. It commenced with an inspiring keynote by Briggs Morrison, who illuminated the critical need for a systems approach in drug development, highlighting both challenges and opportunities. Participants received clear, distilled explanations of systems and systems thinking. A pivotal segment involved panelists bravely sharing "failure" stories, creating a "safe space" for candid discussion. These "misadventures" were then analyzed through the lens of systems thinking to explore how different outcomes might have been achieved. Key areas of discussion included:

• Errors and Quality by Design: Defining quality as the "absence of error that matters" and reframing errors as invaluable opportunities for learning, drawing parallels from air transport "crashes and near misses". Discussions also differentiated between ignorance and ineptitude.

• Complex Adaptive Systems: Recognizing clinical research as a dynamic, complex "eco-system" under immense pressure. The goal was to understand and dismantle existing silos by applying systems thinking, which inherently examines how all parts interact and influence each other.

• Sites & Dynamic Accreditation: Exploring the concept of a global network of "clinical trial labs" enabled by standards and technologies for secure data flow. A significant finding noted that 36% of clinical trial budgets are spent on monitoring, not data accuracy. The urgent need for "dynamic accreditation" (real-time performance assessment) for continuous improvement was emphasized.

• "Misadventures": Common Themes of Systemic Failure: Identifying widespread issues such as the lack of an international bridging system, difficulties in standards mapping, commoditization of sites, lack of leadership, misaligned stakeholders, and rigid compliance for the wrong reasons.

• Innovation: Deliberating how systems thinking can foster genuine innovation, addressing the tension between conservatism and innovative thinking in drug development. The absence of a "skunkworks" for clinical trial work and barriers to innovation, such as a high "pain threshold" and risk-averseness, were highlighted. It was noted that disruptive innovation is more likely to emerge from outside established organizations.

Day 2: Crafting Strategies and Tools for Change (Soft Systems Methodology) 

The second day introduced the practical steps of SSM, empowering participants to devise solutions that are both effective and acceptable to multiple stakeholders. Three facilitated panels were instrumental in eliciting diverse "worldviews" – the deeply held beliefs and behaviors that shape how stakeholders interpret reality and make decisions. Understanding these distinct, yet valid, worldviews is paramount for resolving differences and fostering collaboration, as they often underpin miscommunications and conflict. Following the surfacing of these worldviews, discussions revisited three core topics to pinpoint challenges and strategies for implementing systems thinking, and to outline actionable plans:

Patient Involvement: Addressing inconsistent definitions of patient engagement, the need for real-time monitoring of results, and the shift from protocol-driven to patient-driven protocols. Patients were identified as a "huge opportunity" to drive change by building systems "from the patient up," enabling their expertise and voice. Challenges included accommodating precision medicine, linking existing healthcare data, detecting adverse events earlier, and leveraging social media to shape protocols.

Protocol Optimization: Discussions centered on simplifying overly complex protocols and balancing patient needs with scientific rigor. The conversation also focused on designing protocols that genuinely fit into patients' lives, including those with co-morbid conditions. The potential of AI to identify patient subgroups and the need for improved informed consent processes for conscious decision-making were explored. A key emphasis was on moving towards "seamless development," allowing patients to progress through drug development stages. Pro-active involvement of stakeholders like IRBs, patients, caregivers, and investigators in protocol design was underscored.

Innovative Technology: This session explored whether clinical research effectively leverages technology and how to cultivate an environment that identifies technologies capable of simplifying and improving processes. It addressed the problem of technical and thinking silos, the impeding effect of too many disparate technologies, and challenges related to data security and affordability. The critical need for universal identifiers and standardizing elements across trials was highlighted. Participants shared "Ah-ha" moments for technology applications, focusing on alleviating frustrations like learning from past trials, accessing integrated quality data, and eliminating waste.

Key Findings : The Power of Perspective 

1.  Participants, while expert in their own domains, were often unaware of – and surprised by – how others viewed the same issues.

2.  Identifying and discussing these differences proved incredibly energizing, sparking innovative insights and practical suggestions. These findings validated the hypothesis that a format consciously encouraging the safe sharing of diverse perspectives leads to richer understanding and innovative solutions. This suggests that clarifying existing differences among stakeholders can be as potent as external disruption in fostering innovation.

12 Considerations for a Systems Approach: A Guiding Framework 

The discussions culminated in 12 key elements for adapting systems thinking to clinical research, offering a robust framework for future initiatives:

1. The imperative of a System of Systems approach to address complex interdependencies and foster multi-stakeholder collaboration.

2. Understanding the core components of an enterprise system: People, Process, Technology (PPT), and Policy, with a strong emphasis on inter-connectivity and human factors.

3. Assessing both internal and external environments to ensure universal buy-in for solutions.

4. Utilizing "World View" as a critical entry point to understand and overcome silos, resistance to change, and competing interests.

5. Recognizing the inherent seamlessness of research continuity despite current fragmented approaches.

6. The vital importance of simplicity and reduction of complexity in systematizing processes, moving from rigidity to agility.

7. Leveraging new methodologies, paradigms, and tangible examples to demystify and address complexity.

8. Developing a common "systems language" as a unifying taxonomy to facilitate communication across enterprises.

9. Focusing on "differences that make a difference" – identifying and addressing what truly matters and has the highest impact.

10. Applying Control Structures from other fields to clinical research, particularly concerning professional standards, training, and development.

11. Establishing Standards for fundamental processes that extend beyond mere SOPs and reflect significant real-world impacts.

12. "Stepping back" to gain a holistic vision, understanding perspective, need, environment, and vision before defining solutions.

The ACRES Synergy event was an important event, laying a strategic foundation for a future where clinical research is more efficient, innovative, and deeply impactful for patients worldwide.