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International Clinical Trials

The Resilience of Real-World Data



Real-world data (RWD), or patient data derived from sources outside of traditional clinical trials, are increasingly being used to drive innovation across the healthcare industry. The expanded use and value of RWD spans across the trial lifecycle and the broader healthcare industry. The impact of this data is being seen in everything from clinical development, regulatory decision-making, pricing, and access to healthcare – and regulators are supportive. Following the 21st Century Cures Act, which placed additional focus on the use of these types of data to support regulatory decisions, the FDA has published extensive guidance to support and encourage the use of RWD in clinical research, and many other regulatory bodies around the world have followed.

Most significantly, RWD is being used to support trial design to both predict clinical response and select appropriate outcome measures. In clinical trial recruitment, it can help identify eligible patient populations more quickly, leading to more cost-effective trials and new therapies being brought to market faster.

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About the Author

Paul O’Donohoe is Scientific Lead, eCOA and Mobile Health at Medidata, a clinical software platform provider and a Dassault Systèmes company. He is responsible for developing the company’s scientific expertise for eCOAs and mobile health, and is responsible for ensuring internal teams, partners, and sponsors are following industry, regulatory, and scientific best practices when it comes to integrating technology into clinical trials. He is passionate about developing the field of eCOA and mobile health through research and active involvement in industry consortia, and is currently the Industry Vice-Director of the C-Path ePRO Consortium. Prior to Medidata, Paul was Director of Health Outcomes at CRF Health, an eCOA provider.
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