Indian Trials Recover Amid Lingering Pandemic Challenges
Virtual Tools Part Of The Future?
The Indian clinical research segment has managed to retain some buoyancy despite pandemic-related disruptions, with an estimated 70 global trials cleared to October by the regulator. But audiovisual recording of the informed consent process has been particularly challenging in the case of subjects in isolation wards.
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The coronavirus pandemic has thrown up unprecedented challenges for the Indian clinical trials segment, as in other parts of the world. Experts tell Scrip how things are poised in the country including potential impact on some critical milestones, but efforts are underway to tackle the crisis.
A protocol amendment is not needed to pause enrollment to decrease potential exposure to COVID-19, and virtual visits can be immediately implemented to ensure safety; experts say pandemic is forcing a rethinking in how companies carry out trials and in how regulators ensure patient safety and trial integrity.
Clinical trials in a range of diseases continue to be impacted by concerns about patient safety and health care resources as the COVID-19 pandemic grows.