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Biopharmaceutical sponsors should make urgent decisions now to plan for continued clinical research in the coming months.
In accordance with recommendations from the FDA, there are four key actions that biopharmaceutical sponsors can take immediately to offset disruptions:
These are just a few questions among many that need to be sorted out. To plan for the short- and long-term scenarios, sponsors should go back to the drawing board and reevaluate overall clinical study design, including patient eligibility, feasibility, enrollment, timelines and budgets against the evolving global landscape.
Sponsors should note that these strategies may require amendments to study protocols, and the FDA guidelines urge sponsors to engage with institutional review boards (IRBs) as soon as possible. However, in cases where protocol changes are made to directly eliminate hazards to patients, these may be implemented6 without IRB approval. Finally, alarming projections indicate that social distancing countermeasures may need to be in place well into 20217, which means that biopharmaceutical sponsors should make urgent decisions now to plan for continued clinical research in the coming months.
Sharma Ramanathan is a manager in ZS’s San Francisco office. Ronald Du is a manager in ZS’s Los Angeles office. Mike Martin is ZS’s global clinical lead, based out of ZS’s Princeton office. Arvind Chavali is an associate consultant in ZS’s San Francisco office.
Editor’s Note: The full version of this article will be available in our April digital edition on April 13.