ecentralized clinical trials (DCTs) have become a cornerstone of modern clinical research, driven by advancements in digital health technologies and artificial intelligence (AI). DCTs have grown rapidly, with a projected market value of $13.3 billion by 2030, growing at a compound annual growth rate (CAGR) of 6.6%. The integration of cutting-edge technologies such as wearable devices and AI-powered analytics has enhanced trial efficiency and patient monitoring. Despite this impressive growth and the sector’s importance in reshaping clinical trial methodologies, DCTs still face significant challenges in implementation, standardization, and global adoption.

We present the top 10 challenges facing DCTs in 2025 and beyond, along with innovative solutions that leverage technology, regulatory frameworks, and patient-centric approaches to overcome these obstacles.

DCT Advancements So Far

Regulatory agencies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have established comprehensive guidelines for DCT implementation, emphasizing data integrity, patient safety, and adherence to trial protocols in remote settings. These efforts are complemented by global initiatives aimed at harmonizing DCT standards across regions, ensuring consistency and reliability in clinical research practices.

While focus has been put on patient-centric approaches, it is also important to evolve training and certification technologies to ensure that patient and public safety within DCTs are protected. By automating compliance monitoring and streamlining adherence to proper training and certification, regulatory technologies ensure that trials meet stringent standards for data integrity, patient safety, and protocol adherence. These technologies enable real-time oversight of remote trial activities, helping identify and mitigate risks such as data variance and noncompliance in diverse and decentralized settings. Additionally, these technologies facilitate seamless communication between stakeholders—patients, investigators, and regulatory agencies—ensuring transparency and accountability throughout the trial process.

DCTs have also improved participant diversity through remote access and culturally tailored recruitment strategies. While the COVID-19 pandemic accelerated DCT adoption, with hybrid models emerging as standard practice, several critical issues remain unresolved. These include maintaining data quality in remote settings, navigating complex regulatory jurisdictions, ensuring technology accessibility, and overcoming historical barriers to diversity in clinical trials.

Optimizing DCT Challenges and Solutions

1. Data Integrity and Patient Safety
   • Challenge: Maintain data quality and ensure patient safety in remote settings without compromising trial integrity.
   • Solution: Implement advanced remote monitoring systems using AI and digital devices for real-time data collection and analysis. Establish clear protocols for virtual patient assessments and emergency responses.
   • Evidence: The ADAPTABLE trial, conducted by Duke Clinical Research Institute and Medidata, used eConsent, eSource, and patient-reported adverse events to ensure data integrity and patient safety in a fully decentralized setting. These tools allowed real-time remote data collection and monitoring while maintaining trial integrity.
2. Regulatory Compliance and Adaptation
   • Challenge: Navigate complex and evolving regulatory jurisdictions across different regions for DCT implementation.
   • Solution: Create a centralized, regularly updated regulatory guidance database for DCTs. Implement automated compliance checking systems to ensure adherence to regional and global regulations.
   • Evidence: The TREAT Now study implemented a centralized regulatory framework using direct-to-patient drug shipping and remote monitoring technologies, ensuring compliance across multiple jurisdictions. This approach streamlined regulatory approvals while maintaining adherence to regional requirements.
3. Technology Infrastructure and Accessibility
   • Challenge: Ensure that all participants, sites, and healthcare providers have access to necessary technology for DCT participation.
   • Solution: Develop standardized, user-friendly technology platforms easily integrated into existing site systems. Partner with telecommunications companies to provide subsidized devices and internet access. Offer ongoing technical support and training for site staff.
   • Evidence: The REACT-AF study provided participants with preconfigured Apple Watches and a cloud-based mobile app for remote monitoring of atrial fibrillation events. This ensured technology accessibility while enabling seamless integration into participants’ daily lives.
4. Diversity and Inclusion Initiatives
   • Challenge: Overcome historical barriers to diversity in clinical trials, even with increased accessibility through DCTs.
   • Solution: Develop targeted outreach programs in underserved communities for specific trials and therapeutic areas. Utilize AI and big data analytics to identify and address specific barriers to participation for diverse populations.
   • Evidence: The Early Treatment Study, a decentralized COVID-19 trial, significantly improved diversity compared to a traditional clinic-based trial. Results showed 30.9% Hispanic or Latinx participants (vs. 4.7% in the clinic trial) and 12.6% from nonurban areas (vs. 2.4%). This highlights remote designs and online recruitment’s effectiveness in including underrepresented groups.
5. Participant Engagement and Retention
   • Challenge: Maintain participant engagement and compliance without regular in-person visits.
   • Solution: Implement AI-driven engagement strategies, such as personalized reminders and gamification elements. Develop culturally sensitive communication protocols to improve retention across diverse populations.
   • Evidence: A fully decentralized clinical trial (PROMOTE) in Singapore, focusing on maternal mental health, achieved a high participant retention rate of 97% by utilizing virtual visits, mobile apps for data collection, and home delivery of study products, making the trial convenient and safe for participants, particularly during the pandemic.
6. Investigator and Site Staff Adaptation
   • Challenge: Investigators and site staff may struggle with new technologies, increased administrative burdens, and remote trial management.
   • Solution: Implement AI-powered workflow management systems to automate routine tasks. Offer dedicated virtual research coordinators. Provide comprehensive, role-specific training and certification programs for DCT management, utilizing virtual reality and simulation-based training.
   • Evidence: A 2024 publication emphasizes structured site readiness practices for DCTs, including comprehensive training programs for investigators and site staff on new technologies and virtual tools, which improves their adaptation to decentralized methods and enhances their ability to manage diverse data streams and expanded roles in DCT environments.
7. Data Management and Security
   • Challenge: Ensure data integrity and security across multiple digital platforms and remote collection points.
   • Solution: Implement blockchain-based data management systems and advanced encryption protocols. Conduct regular security audits and provide data management training for site personnel.
   • Evidence: The PROMOTE DCT cited above emphasized the importance of careful planning of data flow, database structure, and data protection measures to ensure data quality and security.
8. Local Healthcare Provider Integration
   • Challenge: Ensure seamless collaboration between trial teams and local healthcare providers unfamiliar with DCT protocols.
   • Solution: Develop a secure, standardized communication platform for information sharing. Provide tailored training modules for local providers on DCT protocols and their role in supporting trial participants.
   • Evidence: The Systems Thinking Framework for Decentralized Clinical Trials integrated local healthcare providers into DCTs using secure communication platforms and tailored training modules. This approach improved trial oversight, data quality, and participant care while enhancing collaboration across the trial ecosystem.
9. Cultural Competency in Remote Interactions
   • Challenge: Maintain cultural sensitivity and effective communication with diverse participant populations in virtual settings.
   • Solution: Implement AI-driven language translation and cultural adaptation tools for trial materials and communications. Provide comprehensive cultural competency training for research staff.
   • Evidence: BackInAction Trial (PRISM NIH Collaboratory), a hybrid trial, improved cultural competency through culturally and linguistically adapted patient-reported outcome measures. It emphasized cognitive testing for accurate cultural adaptation of trial materials, enhancing inclusion and results generalizability. Findings highlight the importance of such adaptations in improving trial accessibility for diverse populations.
10. Remote Training and Certification Management
    • Challenge: Deliver effective training programs remotely while ensuring consistent engagement and proper credential verification.
    • Solution: Develop interactive, user-friendly training platforms with simulations and real-time feedback. Implement a globally standardized, verifiable, shareable digital credentialing system using blockchain technology.
    • Evidence: The ClinOps Training Program (2025), a hybrid clinical trial operations training program in Africa, improved remote training and certification management using Moodle LMS and VoiceThread for interactive sessions and real-time feedback. Results showed increased participant proficiency.

Conclusion

DCTs continue to transform clinical research through the adoption of digital technologies and patient-centric remote approaches that improve access, efficiency, and inclusivity. Because DCTs minimize the need for in-person visits, they dramatically improve representation from underrepresented groups, leading to more generalizable trial outcomes.

However, there are still challenges such as optimizing training and certification for healthcare professionals and building trust among principal investigators in a remote oversight environment. Some of these could be overcome by employing friendly platforms, engaging solutions for training, and strict safety protocols.

Moving forward, more work on DCTs creates a host of possibilities with regard to creating newer methods and facilitating collaboration that has kept and will keep medical research progressive, less expensive, and more centered on the needs of patients.

To learn more about DCTs, plan to attend our Clinical Innovation and Biostatistics Summit.