When COVID-19 triggered nationwide lockdowns and travel bans, pharmaceutical industry regulators across the globe were quick to respond. Within weeks, virtually every regulatory body had produced guidance or advice for industry on how to manage their ongoing and future trials during the pandemic. The call was clear: leverage the tried and tested technology that we have today to continue critical clinical research, help patients and drive innovation.
Regulatory action was a critical catalyst to adapting protocols and workflows to continue in the COVID-19 environment. These guidance documents encourage sponsors to complete a risk-assessment of their ongoing clinical trials, and employ risk mitigation measures to ensure patient safety. Many regulatory bodies acknowledged the need for operational flexibility in responding to COVID-19, and most encourage the use of virtual trial elements. These include remote monitoring, televisits, and alternative means to deliver investigational drugs to patients as ways to prioritize patient safety and maintain trial progress.
Even regulators who previously did not support virtual trial elements are now allowing their limited use to ensure patient safety, when appropriate, during the pandemic.
This swift and concise response gives sponsors the tools they need to ensure the safety of patients and clinical teams, continue progressing clinical trials through the pandemic, and protect vital research data in this unprecedented environment. Piecing the guidances together, sponsors have a global resource that informs their decisions around regional resource allocation, efficient shipment of study drug, and safety monitoring.
The ongoing uncertainty related to COVID-19 means these guidances and regulatory opinions will continue to evolve. There is not one destination of a single, final “plan,” but a series of continuous assessments of risk to the clinical trial and to patient safety in an ongoing assessment of the next best steps for risk mitigation.
To stay abreast of the changes, study teams are actively working with sponsors of ongoing clinical trials to perform risk assessments and impact analysis of COVID-19.
IQVIA encourages sites and sponsors to see the pandemic response not as a single event, but as a process implemented in trials globally that must be measured and routinely updated to meet both acute and ongoing patient needs. As the situation evolves, sponsors will require a well-informed, well-prepared partner with the global and local knowledge and tools in place, as well as the operational scope and agility, to implement new processes to meet the changing needs in each country.
A decision tree approach to risk
At IQVIA, we established a COVID-19 risk assessment workflow, powered by dedicated teams whose sole focus is to read regulations related to COVID-19, interpret their potential impact to current and future studies, and advise study teams, sponsors and site staff on how to adapt. These workflows use decision trees, templates, and instructions to help sponsors conduct initial risk assessments, and determine appropriateness of shipping investigational product, and the use of remote visits and remote monitoring.
The study teams, in conjunction with subject matter experts, assist in the deployment and assessment of these mitigation strategies, and continually monitor newly issued regulatory guidances to update these tools.
COVID-19 has forever changed clinical research. Will it also forever change regulations?
Both the FDA and EMA has been supportive of decentralized clinical research, including remote patient visits and remote monitoring, for several years. However, not every country within Europe fully authorizes televisits in clinical research, remote monitoring, or shipping investigational product to patients as a matter of course in traditional clinical research.
The COVID-19 pandemic has seen many of these previously restrictive countries recommend remote and decentralized tools to ensure patient safety. Eliminating or reducing a patient’s need to be physically present at the site has become a common safety measure. Similarly, in countries where sites would not have been allowed to ship investigational drugs to patients, that practice is being suggested in certain circumstances, as are remote visits.
In their guidance documents, many countries note that once the pandemic is cleared, clinical trials should revert to compliance with standard regulations. For most, this would mean returning to site-based trial models where patient visits and the provision of investigational product are done at a research site.
But as the world emerges from stay-home orders, it’s critical to consider incorporating risk mitigation plans that include virtual trial elements as a standard practice in future clinical trials plans, and have those plans be in accordance with local regulations. The research industry was caught by surprise by COVID. We do not get to say that a second time with any credibility.
Patients and sites around the world are engaging in decentralized research at this moment. These investigators are learning how effective and engaging remote visits can be, and that direct-to-patient shipments of drugs and home health visits can lessen patient burden.
The COVID-19 global response has shown that a patient can participate in clinical research from their home, without the need to take time off of work or get dependent care in order to participate in a clinical trial visit. Will we reposition that burden on patients after the pandemic passes, now that we and the patients have experienced effective remote research?
I appreciate the conversations this new collective reality is sparking in regulatory environments and clinical research, and I’m looking forward to where this new knowledge and discussion will take us. Most of all, I am proud of the advancements in virtual research that IQVIA has made, that allow us to be a productive partner to sponsors, sites, and patients in this journey.