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Pediatric Clinical Trial Participants Safety During a Pandemic

Thank you to Covance for sharing a guest blog post to the iCAN community. We are excited to have the team at Covance participating during the Virtual 2020 iCAN Summit. If you have not registered, please visit our registration page at

As clinical trials worldwide are facing unprecedented challenges with the COVID-19 pandemic, the experts working at the regulatory bodies and pharmaceutical companies and staff working at contract research organizations (CRO), such as Covance, have a focus to maintain patient safety as a top priority. Almost overnight we saw many hospitals shut their doors to non- essential staff, which restricted access by clinical research teams, and physicians began to weigh the risk and benefits of their patients attending scheduled clinical trial visits. The goal of pediatric and adolescent clinical research and clinical trials is to provide a regulated and monitored platform to advance new therapies and treatments for diseases and conditions affecting these patients. With an unexpected event such as a global pandemic, continuity of patient participant safety, ongoing care, safety reporting of adverse events, and data quality are all vital considerations. Without measures to address these assurances, participation in clinical trials would be unsuccessful in advancing therapies and treatments. As an organization that is charged with assisting pharmaceutical and biotech companies in performing their clinical trials, Covance had to immediately consider what we would face should a pandemic be declared. Since we had operations and offices in China, where the pandemic was first identified, we started our planning very early. Covance was able to learn from early actions in China which helped inform measures in other countries where we had active clinical trials, clinical trials staff and other functions. From a CRO perspective, creating a patient-focused continuity plan involves the alignment of several coordinated actions to both proactively evaluate trials and implement innovative solutions that allow trials to continue caring for patients and collecting information. Across the spectrum of drug development and clinical trial work, this includes:

• Supporting trial sites to provide patients with access to adequate care, either on- or off- site (virtually)

• Ensuring supplies and staffing are adequate for ongoing studies and animal care

• Providing hospital and clinic visiting staff with adequate personal protective equipment

• Examining clinical trial testing processes for verifying data integrity, collecting specimens, distributing the Investigational Medicinal Product (IMP), and transitioning data reviews and verification that are usually conducted in person to virtual reviews

• Partnering closely with key suppliers to address ongoing supply needs

• Rapid implementation of virtual tools and technology for communications, data collection, and patient engagement

• Implementing remote working solutions for various teams that previously worked in buildings that are now closed or are at reduced occupancy

From there, our teams focus on each site individually. Recovery and restoration of clinical trials involves examining the impact of COVID-19 at each site to plan re-entry along with a central operating workstream to oversee each element of the trial that supports maintaining continuity, protecting patients, and preserving or reaching critical endpoints. From study start- up to close out, our teams are monitoring risk and identifying specific actions, which combine forward thinking planning with strategic support. All of this is done to maintain patient safety and preserve as much data as we can to bring trials to conclusions which overall, will help future patients. With our rapid response plans in place, we are well-positioned to act quickly as clinical trials return to pre-COVID-19 levels.

We are looking forward to working iCAN in 2020 and specifically at the 2020 International Children’s Advisory Network (iCAN) Virtual Summit, starting Monday, July 13. Along with a consortium of children’s advisory groups, academia, non-profit/healthcare entities and institutions, we hope to work together to change the future of pediatric medicine.

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