Are Decentralized Clinical Trials an Answer to Emerging Industry and Regulatory Needs in Clinical Research?

Advancement of technology unseen or unexplored in the past is now part of our daily life and activities. Pharmaceutical and MedTech companies are also evolving rapidly and research and development are being supported by remote methodologies such as Computer-Aided Drug Design, AI-based simulation studies, and Remote and Decentralized Clinical Trials (DCT).

Decentralized Clinical Trials can be defined as a clinical research process that includes some or all trial-related procedures (eConsent, telemedicine, eCOA, home treatment) and data acquisition (digital data capture and backup, use of sensors, local labs, imaging, healthcare providers-HCP) taking place at locations remote from the investigator or clinical site. DCT can be effective in bringing out more efficient products to the market while reducing the cost of burden and becoming beneficial to overall healthcare needs for medicines, devices, and diagnostics. DCT is also an opportunity for home administration or home use of investigational medical products.

In this whitepaper, we explore the opportunities for researchers, sponsors, and investigators to consider while designing and implementing a decentralized clinical trial, its importance, and how it is causing a paradigm shift in clinical research. Further, we discuss how DCT can be the answer to many inadequacies of traditional onsite trials. The need for change in regulatory norms and standards and finally the various issues and potential benefits with DCTs.

Key takeaways from this whitepaper:

• Understanding the concept of Decentralized Clinical Trials
• Decentralized Clinical Trials (DCT) vs. Traditional On-site Trials
• Regulatory evolution on DCT
• Roles and responsibilities in a DCT
• Fourteen practical points for a successful DCT
• And more