Navigating the Future: Decentralized Clinical Trials, Challenges, and the Importance of Adaptation
Deepak Behera, MD
CEO | CMO | Advisor: Clinical Development, Medical Affairs, Radiopharmaceuticals, Clinical Trials
The landscape of clinical research is continually evolving, and Decentralized Clinical Trials (DCTs) are an increasingly relevant aspect of this transformation. The FDA's recent publication of draft guidance on DCTs highlights the importance of understanding the underlying thinking behind their guidance and addressing the challenges of incorporating remote participation and expanding access to diverse patient populations. It is important to explore the impact of DCTs on clinical research and the industry's need to adapt by leveraging technological advancements while maintaining high standards for drug safety and data integrity.
Here's the link to FDA's guidance: https://www.fda.gov/media/167696/download
The Emergence of Decentralized Clinical Trials:
Many clinical trials today already include decentralized elements, enabling participants to take part in certain trial-related activities away from traditional clinical trial sites. Telehealth and digital health technologies have played a significant role in making this shift possible, allowing for fewer in-person visits and greater convenience for trial participants. While DCTs offer benefits such as facilitating research on rare diseases and improving the engagement, recruitment, enrollment, and retention of diverse clinical populations, they also come with unique challenges that need to be addressed.
Types of Decentralized Clinical Trials:
DCTs can be classified into two main categories: fully decentralized trials and hybrid decentralized trials. Fully decentralized trials are appropriate for investigational products that are simple to administer, have well-characterized safety profiles, and do not require complex medical assessments. Hybrid decentralized trials, on the other hand, are more suitable when complex medical assessments or product administration need to take place at a clinical trial site, with some follow-up assessments performed remotely. In these hybrid trials, traditional clinical trial sites still play a crucial role in executing parts of the trial, ensuring that necessary procedures are carried out with the required rigor and expertise.
Challenges and Considerations:
Decentralized clinical trials present challenges that researchers must consider and address. Coordinating trial activities across multiple non-traditional clinical trial sites can be complex. To successfully implement a DCT, it's crucial to provide proper training, oversight, and proactive risk assessment and management. Early discussions with relevant FDA review divisions regarding the feasibility, design, implementation, or analysis of a DCT are also essential. By acknowledging these challenges, researchers can better adapt their practices to accommodate the shift towards decentralization.
Adapting to Industry Needs and Technological Advancements:
The industry must strive to understand the underlying thinking behind the FDA's guidance on DCTs and adapt by leveraging the best aspects of technological advancements for operational efficiency. It is crucial to strike a balance between embracing innovation and maintaining the highest standards for drug safety and data integrity. By doing so, researchers can ensure that the shift towards decentralized clinical trials benefits patients while preserving the quality and rigor of clinical research.
Conclusion:
Decentralized Clinical Trials are an important development in the world of clinical research. While they offer potential benefits, it's crucial to address the challenges and considerations they present. As an industry, we must adapt to this shift by leveraging technological advancements, maintaining the highest standards for drug safety and data integrity, and recognizing the continued importance of traditional clinical trial sites in executing certain aspects of hybrid trials. By working together, we can continue to drive progress in the field and ensure the future of clinical research remains focused on improving patient care.