The adoption of patient-facing digital components within clinical trials has been around for a decade, yet designing and conducting digitally-enabled clinical trials - hybrid or fully decentralized - remain a challenge for many researchers and sponsor organisations.
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Governing bodies, industry leaders, agencies such as the EMA and FDA, and early studies highlight the potential benefits of DCT and hybrid technology as a participant-centric approach to accelerate study recruitment, engagement, and endpoint collection. However, enabling digital technologies in clinical trials necessitates a clear understanding of these options, their potential in specific therapeutic areas, their limitations, and a clear methodology to incorporate them into study protocols.
This whitepaper includes:
- An introduction to hybrid and DCT technology trends across today’s research landscape
- An overview of main benefits and considerations when leveraging decentralized or hybrid study types
- Initial considerations to incorporate when assessing the potential use and suitability of hybrid and DCT components.
This whitepaper is intended for clinical research professionals, investigators and sponsors wishing to gain a general understanding of hybrid and decentralized trial technologies, and to provide early guidance in assessing their value and adequacy within study protocols.
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