Regulatory Affairs: Mitigating COVID-19’s Impact on Clinical Trials
Ilse Marie Nolan, senior director, global regulatory affairs and Sarah Ward, director, project management, discuss how the PPD® FSP model can help support our partners’ regulatory needs during the COVID-19 pandemic.
Due to the recent upheaval caused by the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) has issued guidance providing some flexibility for clinical trials, however, there is no one-size-fits-all approach to applying such guidance. To ensure consistent compliance with regulatory updates, PPD continues to gather information from multiple agencies and update regulatory intelligence daily, both from a study level and a country-by-country basis.
Deviations will be evaluated when considering trial results, but investigators need to ensure they are recording any protocol modifications, deviations and missing data. At PPD, our functional service partnerships (FSP) model offers agility and flexibility to support our partners’ regulatory needs, giving them confidence their trials will remain up and running while minimizing impact from COVID-19. With access to regulatory intelligence from studies across the PPD enterprise, as well as country-specific updates via our global reach, we provide our FSP clients with insights well beyond the scope of their studies.
The “new clinical trial normal” has brought with it a number of factors to consider from a regulatory perspective. They include:
Risk assessment. Perhaps the most critical element from a regulatory lens is the importance of a sponsor’s risk assessment. For example, FDA guidance specifies that sponsors “carefully consider context-dependent issues” when continuing to administer an investigational product. This would enable them to evaluate any impact that pandemic circumstances could have. Further, any risk mitigation should occur often and be considered carefully.
Remote monitoring. Another major impact of COVID-19 has been the rapid and massive move to remote monitoring and the accompanying implications. Adoption – and adaptation – of technology has been a large component. Using EMRs, eCOA, ePRO, telemedicine, and other virtual applications has made the move to centralized and remote monitoring possible, but there remains a need to continue to ensure compliance. PPD deploys our proprietary regulatory intelligence platform, PPD® RegView, to effectively collect and disseminate specific intelligence.
Study drug delivery. Regulations vary by country, but, if permissible, sponsors or sites may send the study drug directly to the patient. Alternatively, a patient may be allowed to transfer to another site or patients may be allowed to be supplied with additional quantities of the study drug to minimize the need for them to travel to the sites.
Data privacy. In addition to data privacy concerns that researchers typically navigate, the pandemic is increasing the need for vigilance. Remote working, adapting new-to-the-study technology and, unfortunately, scams and phishing attacks create real cybersecurity concerns. Our regulatory teams continually monitor and evaluate the security and efficacy of data communication, along with ensuring compliance with standard privacy measures.
FSP regulatory affairs experts at PPD help our partners remain flexible and agile to address any existing or as-yet-unknown regulatory concerns that may arise during the pandemic and its aftermath. Having established relationships with sponsors and access to global regulatory information via PPD RegView allows our regulatory affairs team to provide keen insights into a complex and fluctuating situation that will inevitably continue to change and evolve.
Since the onset of the pandemic, our Regulatory Intelligence, Policy and Advocacy team has been collaborating even more closely with our global regulatory country network while proactively contacting regulatory authorities to obtain current regulatory intelligence for new and ongoing trials, ensuring our partners can remain confident as we navigate through this time together.