Regulatory Insights: COVID-19 and its Impact on the Regulatory Affairs Landscape
Our new blog series, “Regulatory Insights,” shares informal updates, describing hurdles faced by our industry, related regulatory issues and practical examples of how we at PPD manage them. In this first post, Cindy Elko-Simms, M.D., senior vice president of pharmacovigilance, regulatory affairs and medical writing, discusses COVID-19 and its impact.
Now more than ever, with the onset of the COVID-19 pandemic, PPD teams and our sponsors turn to our regulatory affairs organization for guidance to support key business decisions. While beyond this unprecedented health crisis, dynamics within the clinical development landscape, as well as political and economic pressures, present ongoing issues that affect regulatory affairs and require our attention.
COVID-19 and its Impact on the Regulatory Affairs Landscape
On March 11, 2020, the World Health Organization declared the coronavirus outbreak a pandemic. Across the globe, governments, institutions and industry began responding to mitigate the deadly impact of the virus. With the unprecedented strain on health care systems worldwide and extraordinary measures in place to protect public health, the threat of clinical trial and regulatory delays due to the coronavirus outbreak is real. According to industry reports, the upward trend in clinical trial delays continues, with more than 500 delays reported as of the second week of April.1 From a regulatory standpoint, the ability to find solutions to maintain trials was initially restricted by prevailing regulations, creating an urgent need to determine what flexibility could be incorporated in impacted jurisdictions.
Regulatory authorities and ethics committees began releasing guidance in March to provide a path forward. Broadly speaking, regulatory authorities are taking a pragmatic approach to trial continuity, with a clear focus on ensuring the safety of patients and clinical trial site personnel while maintaining data integrity and adhering to good clinical practice (GCP). They require sponsors to conduct ongoing risk assessments to determine the appropriateness of setting up new studies or continuing with current studies. Authorities are generally willing to allow sponsors to introduce temporary interim measures to support continuity to patients in trials when possible. PPD’s regulatory experts are monitoring closely. Critical to global medical product development, guidances vary by country or jurisdiction and are continuously updated, with some more granular than others.
PPD and its sponsors are working to gather this intelligence to enable trials to adapt. Our regulatory intelligence team routinely gathers, assesses and disseminates regulatory guidance to our study teams and clients to support business decisions. We review and capture this information in our in-house, proprietary regulatory intelligence platform, PPD® RegView, which can be easily tailored to collect and disseminate specific intelligence. With this view across most major impacted countries, we work with regulators, sponsors, sites and investigators to adapt to continue trials where feasible. The essential elements to successful study execution of trials now may include options such as direct-to-patient supply, conversion of in-person visits to phone/telemedicine visits, use of digital signatures, use of remote source data verification, alternative informed consent procedures, and transfer of patients between sites.
In the sphere of clinical development, the race to find both treatments and vaccines to combat the virus is on. For COVID-19 programs, we have identified areas of importance and tracked guidance by this topic for every country where we manage trials. With this knowledge, we’ve been successful in getting COVID-19 treatment trials up and running quickly, achieving among the fastest startup times in our experience.
Looking ahead in the pandemic, what do we expect?
Our deep, ongoing analysis of regulations and new measures issued by regulatory authorities will aggressively continue. To date, regulatory authorities have repeatedly advised that emergency measures being facilitated during the pandemic are only interim measures, and that we will essentially revert to business as usual once COVID-19 is under control. However, we at PPD, along with other industry experts, recognize the circumstances of the COVID-19 pandemic create important opportunities to change and improve the way clinical trials can be run going forward.
As an example, the move toward digitally enabled clinical trials may cut down or eliminate face-to-face site visits. If we can successfully demonstrate adoption of a digital framework that safeguards patient safety and produces accurate and reliable data during the pandemic, this will help fuel the needed agency buy-in to progress this promising approach beyond the pandemic. At PPD, we are focused on helping regulators see the future potential of the innovations being implemented during this critical time.