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In Bloomberg Law, Valerie Bonham Evaluates Clinical Trial Rapid Data Reporting

Practices: Life Sciences, Health Care, FDA Regulatory, Clinical Research, Digital Health, Health Privacy & Security

The need for reliable COVID-19 treatments is prompting some to suggest that the U.S. government invoke unusual legal authorities to require certain study sponsors, including some drug companies and researchers funded by the National Institutes of Health, to post into study results for completed trials into a federal database, ClinicalTrials.gov, within a month rather than the year currently allowed under law. 

In a Bloomberg Law article, health care and life sciences counsel Valerie Bonham (Washington, D.C.) explains that building consensus around the need for rapid reporting is critical. But she also notes that given the size of many clinical trials, performing complete quality control and reporting out results into the structured format of ClinicalTrials.gov within weeks could be quite difficult.

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