Adaptive Privacy in Clinical Research with Aarthi Iyer
September 9, 2025
How do you protect patient data when clinical trials move beyond traditional clinic walls? In this episode of Privacy in Practice, hosts Kellie du Preez and Danie Strachan sit down with Aarthi Iyer, Senior Director & Senior Corporate Counsel at Cogent Biosciences and Microsoft Fellow, to explore the evolving landscape of privacy in clinical research. From managing decentralized trials with wearables and apps to navigating AI applications like synthetic control arms, Aarthi shares insights on balancing innovation with patient protection. Whether you're working in clinical research or simply interested in how privacy adapts to emerging technologies, this conversation offers practical guidance on building privacy programs that support both scientific integrity and patient rights.
Clinical trials are rapidly evolving beyond traditional clinic settings, creating new opportunities and privacy challenges. In this episode of Privacy in Practice, hosts Kellie du Preez and Danie Strachan welcome Aarthi Iyer, Senior Director & Senior Corporate Counsel at Cogent Biosciences and Microsoft Fellow focused on AI in clinical research.
What You'll Learn:
- How decentralized clinical trials work and what privacy considerations they create
- Why patient data collection through wearables and apps requires enhanced vendor management
- How to balance GDPR consent requirements with informed consent in clinical trials
- What role AI is playing in modern clinical research, from patient recruitment to synthetic control arms
- How to manage complex vendor relationships when dealing with digital health technologies
- Why clinical trial sponsors have unique advantages in privacy compliance
- What privacy professionals new to clinical trials should focus on first
- How to approach controller and processor relationships across global trial sites
- Why pseudonymized data in clinical trials still requires careful privacy protection
- And so much more!
Aarthi Iyer serves as Senior Director & Senior Corporate Counsel at Cogent Biosciences, a clinical-stage biotechnology company developing precision therapies for patients with rare and serious diseases. With experience spanning roles at Dartmouth-Hitchcock Health and clinical research consulting, Aarthi brings a unique perspective on the legal and ethical complexities of data privacy in clinical trials. As a Microsoft Fellow focused on AI in clinical research, she explores how emerging technologies can enhance patient outcomes while maintaining rigorous privacy protections. Her work sits at the intersection of privacy law, clinical innovation, and emerging technologies.
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Episode Highlights:
[00:02:26] Embracing Change as a Privacy Professional The clinical trials landscape evolves constantly, and Aarthi emphasizes that successful privacy professionals must be prepared to adapt. Rather than seeking rigid playbooks, privacy teams should build flexible frameworks that can accommodate regulatory changes, new technologies, and shifting stakeholder needs. This adaptability is particularly crucial in clinical trials, where innovations like decentralized studies and AI applications continuously reshape how data is collected and processed. Privacy professionals should view change as an opportunity to refine and improve their programs rather than a threat to established processes.
[00:03:20] The Data Subject-Centered Shift in Clinical Research One of the most significant changes Aarthi has observed is how privacy regulations have placed data subjects at the center of clinical research considerations. Unlike other areas of drug development that focus primarily on scientific and regulatory requirements, privacy compliance requires constant consideration of individual rights and protections. This shift has improved the research landscape by ensuring that patient perspectives and rights are integrated into trial design from the beginning, creating more ethical and transparent research practices.
[00:15:05] Decentralized Clinical Trials Decentralized clinical trials allow patients to participate from their homes using wearables, apps, and remote monitoring devices, significantly improving access for rural and vulnerable populations. However, these innovations create complex privacy challenges around continuous data collection, vendor management, and ensuring appropriate safeguards are in place. Organizations must carefully evaluate digital health technologies, establish clear data collection boundaries, and maintain human oversight throughout the process to protect patient privacy while enabling innovative research methods.
[00:21:39] Vendor Management in Clinical Research Clinical trial sponsors have developed sophisticated vendor management processes that other industries can learn from. The approach involves multiple layers: regulatory due diligence using established guidance, comprehensive privacy and security questionnaires, collaboration with experienced clinical sites, and ongoing vendor relationship management throughout the trial lifecycle. The key is recognizing that no single organization can handle all aspects of complex clinical research alone—success requires building trusted partnerships with specialized vendors who understand the clinical trial environment.
[00:29:31] AI Applications in Clinical Trials AI is transforming clinical research through applications like patient recruitment optimization, automated document drafting, enhanced medical imaging analysis, and synthetic control arms for vulnerable populations. These innovations can reduce research timelines, improve patient access, and enhance data quality. However, implementation requires careful consideration of data training sets, bias prevention, regulatory compliance, and patient consent regarding AI usage. The key is focusing on operational objectives and implementing AI tools systematically with appropriate oversight and validation.
Episode Resources: