They dive deeper into the FDA’s evidentiary standards for AI, what organizations should consider about methodological transparency in submissions, and AI’s potential as a tool that can help bring medicines to market more efficiently.

For more information on ACRO's AI/ML Principles Statement, visit ACRO's website: https://www.acrohealth.org/initiatives-hub/ai-ml-in-drug-development/

They dive deeper into the benefits of a risk-based approach, regulator’s thoughts making clinical research more agile, and the potential to help industry bring medicines to patients more efficiently.

They dive deeper into the role that compassion plays in designing successful trials, the importance of including pediatric patients and families in trial protocol design, and creative tools to boost patient engagement 

They dive deeper into ACRO’s annual RBQM landscape survey findings, challenges and opportunities presented by the growth of centralized monitoring and reduced SDR/SDV, and the role that RBQM can play in the future of clinical research.

They dive deeper into the competitive nature of bringing clinical research to a country, process-related challenges that need to be addressed in order to realize the benefits of AI and other technologies, and importance of bi-directional communication between CROs and government.

They dive deeper into highlights from their latest publication, including the benefits of a risk-based approach to trial monitoring and the role that centralized monitoring can play in building more efficient and effective clinical trials.

They dive deeper into the challenges and opportunities in making clinical research more accessible globally, the benefits of standardization in research, how our industry relationship with sites must evolve, and the positive impact that more representative trials have on data quality.

 

They dive deeper into how the clinical research industry can use renewable energy to help meet environmental goals, the importance of promoting more environmentally sustainable shipping and logistics practices, and how our industry can decentralize trial elements responsibly to minimize the environmental impact of the clinical supply chain.

 

They dive deeper into how centralized monitoring can help detect adverse events more quickly and identify underreporting, the benefits of holistically monitoring trial data using centralized monitoring, and how a targeted SDV/SDR sampling strategy can help organizations to conserve resources while maintaining quality and safety.

 

They dive deeper into the role that collaboration between technologists and clinical scientists can play in helping to reduce bias in our AI models, what legislators and regulators should be keeping top of mind as they write new rules of the road for AI and ML, and ACRO’s ongoing efforts to promote the responsible use of AI in clinical research.

 

They dive deeper into the unique roles of SDV and SDR, different methods of implementing SDV/SDR sampling strategies, and the industry imperative to increase centralized monitoring adoption.

 

They dive deeper into the evolution of rare disease patient advocacy groups, why industry must move beyond the hyperfocus on “blockbuster drugs” to make progress in rare disease research, and how advancements in rare disease treatments can benefit the clinical research ecosystem for all.

 

They dive deeper into which advancements in generative AI have the potential to improve the clinical trial workflow, the integration of AI and predictive analytics in risk assessment processes, and the importance of strong change management strategies when implementing new AI technologies.

 

They dive deeper into their experiences implementing the new guidance at their respective companies, the new opportunities that R3 has created in the partnership between CROs and sponsors, and how they envision the future state of R3 once industry has fully embraced the guidance. 

FIND ACRO & TRANSCELERATE'S ICH E6(R3) TOOLS & RESOURCES HERE: https://www.acrohealth.org/initiatives-hub/interpreting-ich-e6r3/ 

 

They dive deeper into how AI can be used to improve protocol design, drive efficiency in localization processes, and modernize clinical operations to expand access to trials and get treatments to patients sooner. 

 

On this episode, site grantee representatives Dr. Ammara Mushtaq, MD (Brooklyn Clinical Research), Dr. Lovie Negrin, APRN (Randomize Now), and Sandra Carmona Torres, BSN (K2 Medical Research) join the podcast to discuss the lessons learned through implementing their pilot projects so far.

 

They dive deeper into how sites can address barriers to participation, the need for consistent investment in building trust and engaging local community members, and the state of clinical research from a site perspective.