Clinical Researcher—August 2020 (Volume 34, Issue 7)
GOOD MANAGEMENT PRACTICE
Carolyn Yanavich, PhD
The novel coronavirus behind the COVID-19 pandemic has affected and upended our lives in many ways. In the research and healthcare arenas, our focus has shifted from studying and treating a multitude of other conditions to the rapid development of novel treatments and vaccines for COVID-19. However, the need for developing interventions and therapeutics for other diseases persists.
With the primary goals of preserving the safety of research participants and staff, as well as maintaining clinical trial integrity, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have provided guidance on the conduct of clinical trials during this unprecedented time. As of June 11, 2020, there are 342,348 registered clinical trials on ClinicalTrials.gov, most of which have been affected by COVID-19. While it’s difficult to fully quantify the pandemic’s toll on clinical research, many of these studies were disrupted by delayed starts, missed visits, or confounding adverse events.
Study sponsors are being forced to make challenging decisions about the future of the products in their clinical portfolios. While pausing new study enrollments and limiting the procedures performed at study visits minimizes the immediate risk of COVID-19, the long-term effects include incomplete datasets and delays in bringing new drugs to the market.
Further, with limited options for onsite monitoring visits, sponsors are relying on clinical monitors to remotely assess both the study conduct and the data. While these remote visits fulfill minimum reporting requirements, sites and sponsors must work closer with monitors to establish easier methods for accessing and reviewing source documents electronically while maintaining participant confidentiality.
Sharing the Burdens
Clinical research staff are facing challenges with novel standards for patient care, revised office hours and procedures, and an increased risk of staff and participants becoming infected with COVID-19. Social distancing is a challenge for busy clinics, and the target population for many therapeutic trials may also include those at greatest risk for acquiring COVID-19. Many sites have restrictions for in-person visits and have been forced to implement new ways to complete follow-up visits virtually. Clinical sites will need to reassess options for alternative waiting areas for patients, such as outdoor pavilions, tented areas, or in their cars, or separating those who are seeking preventative care versus those needing therapy.
Additionally, with the rising global demand for personal protective equipment, sites are facing new challenges with procuring these necessary supplies in order to protect themselves and to safely treat their study participants. These obstacles, when added to an already overtaxed staff, make it harder for our clinical sites to complete study procedures and tests and administer investigational products as prescribed.
As we await the availability of an effective vaccine for COVID-19, we must ask ourselves what the best strategies are for continuing to conduct clinical research studies. Can we ship study products to study participants rather than having them come to the clinic? How can we maximize our available technology to improve on telemedicine for research trials? Will sponsors proactively work with their clinical sites to understand their limitations and determine if study designs and procedures need to be amended or postponed?
Thorough Documentation Means Heightened Integrity
Clinical research sites are tasked not only with keeping people safe from contracting COVID-19, but also with following and maintaining the standards of Good Clinical Practice. In following the old adage of “If it wasn’t documented, it wasn’t done,” sites are encouraged to document any changes to their processes that were directly attributed to the pandemic and to ensure that all study deviations are clearly described.
Data for many of these affected studies will be produced in support of Investigational New Drug applications for products that will be submitted for licensure. While the regulatory agencies, including the FDA and EMA, have granted some study conduct flexibilities due to the pandemic conditions, any deviations from the original protocols for studies must be appropriately tracked and maintained onsite to ensure the integrity of the trial and its reconstruction, if necessary.
While we tend to focus on the logistical burden of COVID-19 on conducting clinical research, the social distancing requirements that are employed to protect us may potentially have a negative effect on clinical trials data. For example, the measure of success of an HIV-1 vaccine is a decreased incidence of novel infections. However, with visits to restaurants, bars, concerts, sporting events, and other socialization activities being discouraged for so long during the pandemic, higher risk behaviors have also decreased, making it harder to determine if the HIV-1 vaccine is indeed effective, or if decreased infections are an indirect result of COVID-19 prevention efforts.
In summary, the way we conduct and manage clinical trials is evolving. While these changes can seem overwhelming, there is the positive potential for developing novel approaches to informed consent, streamlining laboratory procedures, increasing remote or telemedicine visits, or performing home healthcare for our more vulnerable study populations. Sponsors, sites, clinical monitors, and regulators must continue to keep an open dialogue on the best ways to conduct research trials both now and in the future.
Carolyn Yanavich, PhD, has more than 20 years of clinical research experience, including expertise in the principles and practices of clinical trial research, management, implementation, regulatory affairs, and laboratory science. She contributed this article through Kolabtree.