Advancements in technology have enabled virtual visits and remote patient monitoring and have provided new options for data collection. This has forged the path for hybrid and decentralized clinical trials.
These new approaches improve patient experience, data quality, and expedite the clinical trial process. Studies are more accessible and convenient for patients. Investigators gain valuable patient insights, and sponsors get answers to their scientific questions faster.
However, moving in this direction requires change. Trying to incorporate new world innovations into a traditional protocol design and operational practices doesn’t fit. It’s not enough to choose a patient-facing technology, the entire data flow needs to be optimized. Consider the effect on data quality, healthcare professional workflow, patient ability to comply, and feasibility of conducting a trial across geographies.
The hesitancy to change is understandable given the potential impact on an organization. A deep understanding of what constitutes a hybrid or decentralized clinical trial is necessary in order to effectively determine if a shift is the right move.
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