Ronald Du

	In accordance with recommendations from the FDA, there are four key actions that biopharmaceutical sponsors can take immediately to offset disruptions:

For clinical studies currently in flight, sponsors need to virtualize their trial operations

to avoid jeopardizing the safety of patients as well as site staff. In a purely virtual setting, patients are in contact with study teams and trial physicians through smartphone technologies

, and investigational products are shipped directly to patients’ homes. Patients can self-administer therapies if feasible. For more complex procedures and interventions, sponsors can collaborate with third-party home-trial vendors

or incorporate at-home nurse visits. Obviously, the feasibility and logistics of this approach need to be analyzed thoroughly. For example, does a protocol involve procedures that cannot be conducted outside of a hospital setting? 
		 

If clinical research associates are unable to access sites because of global travel restrictions or local quarantines, sponsors should enable remote monitoring and oversight as the FDA recommends. If not already in place, sponsors may need to enable virtual workspaces for sites to upload the necessary documents for centralized monitoring. The Association of Clinical Research Organizations (ACRO) recently laid out emergency guidelines

for sponsors, clinical research organizations and sites on conducting trial oversight during the pandemic. 
		 

Engage patients and investigators through proactive communication.

Developing a communication and remote engagement strategy with patients and investigators that can be sustained throughout the pandemic is vital to ensure motivation and reduce burden. Virtualizingtrials or monitoring sites will only be successful if sponsors frequently engage and empathize with patients and sites in order to assuage concerns caused by COVID-19.
		 

Assess the overall clinical portfolio and evaluate study design, feasibility and operations as the pandemic evolves. 

For each clinical trial in the portfolio, sponsors need to conduct a thorough assessment exercise aimed at answering key questions related to design, feasibility and operations in the immediate term, short term and long term. For example, in the immediate term, sponsors should determine which of their in-flight trials need to pause enrollment and which of their new planned trials need delayed starts. In the short and long term, sponsors should think through: 

		Protocol modifications to incorporate remote patient and site assessments or other virtual elements

		Patient visit requirements and anticipated data collection challenges

		Effective resumption of activities when the pandemic situation improves

		Improvements to risk management planning

		Overall impact on clinical trial and clinical program timelines (including time to approval) 

	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 implemented

without IRB approval. Finally, alarming projections indicate that social distancing countermeasures may need to be in place well into 2021

, which means that biopharmaceutical sponsors should make urgent decisions now to plan for continued clinical research in the coming months.

 is a manager in ZS’s San Francisco office. 

 is a manager in ZS’s Los Angeles office. 

 is ZS’s global clinical lead, based out of ZS’s Princeton office. 

 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. 

https://www.science37.com/wp-content/uploads/2020/03/12161417/Navigating-Clinical-Trials-in-the-Coronavirus-Era_Science37.pdf

https://www.science37.com/blog/siteless-clinical-trials-changing-the-game-for-patients/

https://www.clinicalleader.com/doc/the-benefits-and-challenges-of-siteless-clinical-trials-0001

https://www.acrohealth.org/wp-content/uploads/2020/03/ACRO-Statement-on-Monitoring-Oversight-FINAL-3.13.20.pdf

https://info.zs.com/activeingredient/clinical-development-risks-and-issues-in-a-covid-19-world

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-pandemic

https://www.washingtonpost.com/health/2020/03/19/coronavirus-projections-us/

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Biopharmaceutical sponsors should make urgent decisions now to plan for continued clinical research in the coming months.

Ronald Du

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