The COVID-19 pandemic continues to impact our lives in many ways, and the clinical research industry is no exception. Clinical research and the potential for improving health and delivering life saving treatments must continue, not only to address and mitigate the COVID-19 impact, but to help the millions of people living with chronic disease, cancer, rare diseases and more. Nonetheless, the impact to the clinical trials industry – at least in the near-term – is significant. Research organizations around the world are being required to adjust to a ‘new normal’ that will likely continue and evolve over the next several months or more.
The current environment and dynamics of social distancing present significant challenges for clinical trials. Quarantines, site closures and travel limitations, along with interruptions to the supply chain and the potential site personnel or subjects could become infected with COVID-19 are forcing everyone involved in clinical research to rapidly adapt to uncertain change. Recognizing these dynamics may require significant protocol deviations and modifications, the FDA recently released guidance on the conduct of clinical trials during this public health crisis.
The guidance outlines key considerations for ongoing trials. A significant portion of this section is unsurprisingly focused on ensuring the well-being and safety of study participants. There are multiple issues that need to be considered, including continuing or discontinuing a participant in a trial and the need to conduct appropriate safety monitoring accordingly. For example, when trial participants are unable to visit the site, sites and study sponsors need to consider and evaluate the potential for alternate methods of visits and assessments. At the same time, when trial participants are discontinued or no longer have access to the investigational compound, additional safety monitoring may be necessary.
The FDA also addresses specific COVID-19 screening procedures that may be required by the site to keep both patients and healthcare providers safe. The guidance notes this type of screening does not need be reported as an amendment to the study protocol – even if it is conducted during clinical study visits – unless the sponsor is incorporating the data as part of a new research objective. However, the document does address the likelihood that the current situation may require existing protocols and processes to change. For example, site visit schedules or remote participation and monitoring may require a modification to the study protocol. The guidance provides recommendations about how this should be documented and handled with the IRB and FDA, noting that alternative processes should be as consistent as possible with the original protocol.
Adapting existing technology, or in some instances, adopting new technologies, can be helpful in meeting these new challenges. For example, when necessary, technology can be adapted to enable key study roles – such as monitors – to conduct their work offsite when visits to the study site are difficult or prohibited. In addition, eClinical tools like ePRO can collect data and information directly from participants remotely.
The next several months, possibly more, will almost certainly be uncertain. This is uncharted territory. Gradually reopening our healthcare systems and economy will be a learning process, and the clinical research industry will be required to learn, adapt and evolve. Now more than ever, choosing flexible technologies to support studies will be critical. The ambiguity and mounting pressures can only be addressed with creative technologies that provide a great deal flexibility and enable both study designers and users to quickly evolve and make modifications if necessary. Mednet’s native platform is designed to support clinical trials of any size, type or phase, while also delivering a highly flexible, nimble solution that enables users to easily adapt to an evolving – and even uncertain – future.