August 18, 2020

Tracking the International Effort to Keep Clinical Trials for Non-COVID-19 Treatments Moving

Recently, public attention has been captured by the progress of medical treatments and vaccines against COVID-19, which are currently going through clinical trials (categorized into phases 1, 2 and 3).1

Regulatory agencies in the U.S. and other countries tasked with reviewing and approving these and other medical products have been issuing guidelines and Q&A documents to facilitate their expedited development.2

At the same time, medical products for conditions other than COVID-19 have faced significant headwinds with subject recruitment and retainment and the overall conduct of clinical trials.3

Scientists across government agencies, academia and industry are therefore exploring new ways to continue this much-needed work. Possible adjustments range from behavioral and physical modifications, for example, as recommended by the following regulatory agencies:

Further, as explained in the following publications, others have proposed new statistical solutions:

For additional information on these topics or for help with related regulatory issues, please contact Dr. Lana Lyapustina at Faegre Drinker.

The material contained in this communication is informational, general in nature and does not constitute legal advice. The material contained in this communication should not be relied upon or used without consulting a lawyer to consider your specific circumstances. This communication was published on the date specified and may not include any changes in the topics, laws, rules or regulations covered. Receipt of this communication does not establish an attorney-client relationship. In some jurisdictions, this communication may be considered attorney advertising.

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