Are hybrid clinical trials the “new normal”? We were recently invited by the orthopedic market intelligence firm ORTHOWORLD® to describe our experiences with clinical trials being conducted during the COVID-19 pandemic and to give our expectations as to how adjustments to study operations may be carried through into future trials even after things return to “normal”.
I (Michael Otlewski, Clinical Program Scientist) joined two other industry experts in describing our experiences with clinical trials during the pandemic. We covered the effects that lockdowns and restrictions on elective procedures had on trial enrollment and participant follow-up. Then, we outlined the changes that may be implemented to allow trials to continue, even if in a limited capacity, while describing tools that can be used to allow trials to be conducted virtually where possible. Finally, we each provided a vision of how trials will evolve over the next 5 years based on the new technologies available for remote healthcare and data collection. We predicted that we will see a normalization of hybrid studies that consist of some site visits and some telemedicine or patient-reported components. The convenience for trial participants will likely lead to faster enrollment for trials and better compliance throughout follow-up.
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