PHUSE Single Day Events

India Spring SDE

Saturday 20th March 2021

Virtual Trials Design, Hybrid Trials & Digital Data Collection Methodologies (Mobile Technology, Wearables, ePRO, eCOA, etc.) – Challenges and Best Practices
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Missed the event, or want to watch your favourite presentation again?

The on-demand recording and presentations are available on the PHUSE Engagement Hub.

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Our healthcare system is getting challenged by the day to deliver new and better medicines. A few known reasons are mounting costs of drug development, pandemics, rapid aging of population, advent of technology and devices in healthcare, and a "one size fits all" strategy.

To limit or eliminate the need for patients to travel to an investigational site, industry has embraced virtual/siteless trials and hybrid trials using digital data collection methodologies such as mobile technology, wearables, ePRO and eCOA. This has changed the way data is collected, has reduced cycle times and has increased the availability of patient data to almost near real time, with access to real-world data. We now have access to more data than before and the paradigms of query raising. Data cleaning has changed. While there are advantages, there are known disadvantages due to high and vast availability of data. Statistical algorithms are extensively used in data collection derivations, in issues due to device malfunction, in patient behaviour, and in trials which require complex implant procedures or high-end equipment for MRIs and CT scans. These are available only in clinics and hospitals, with ever-changing technologies and emerging new versions – there are challenges with integrating systems/data. 

Given this, are virtual, hybrid trials sustainable? Is this the new normal? And are we ready?
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Clinical Data Standards in the Era of AI, ML & Digital Transformation – Shrishaila Patil, Navitas Data Sciences

Digitalisation and its Statistical Challenges in Quantifying Treatment Adherence in Asthma Clinical Trials – Megha Agarwal & Sebin Thomas, GlaxoSmithKline

DCTs: A New Way of Clinical Trials – Anand Pendse, Bayer

Hybrid Trials – Fantasy of a Data Manager – Balaji Rajanna, Quanticate

Launching a Healthcare-driven Decentralised Trial – Unique Real-life Use – Hilde Vanaken, TCS Life Sciences & Healthcare

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Raghuram Thata, IQVIA

Contact the SDE Chair for more information about the event.

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