Five Global Bellwether Trends for Clinical Trials

Scott Bass explains why taking a multi-disciplinary, multi-continent approach to the planning of clinical trials will help you anticipate regulatory changes and ward off investigations.

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Scott Bass

New York, Washington, D.C.

sbass@sidley.com

Are China-only Clinical Trials Enough for U.S. Approvals?

Torrey Cope looks at the recent FDA emphasis on the challenges of a China-only trial strategy. He explores the FDA concern that a China-only clinical trial will be unable to prove that a drug is suitable for the U.S. population, and considers the regulatory requirements for U.S. approvals based on ex-U.S. trial data.

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Might the Remote Monitoring of Clinical Trials in Europe Continue after Covid-19 Despite Data Privacy Concerns?

Olivier Goarnisson in Geneva and Francesca Blythe in London look at the benefits that were seen when some European countries temporarily permitted remote monitoring during the pandemic, and consider whether remote monitoring might have a long-term future if data privacy concerns are addressed.

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