COVID-19: Pharma’s Black Swan Moment

By Aman Khera, Global Head of Regulatory Strategy,

Global Head of Regulatory Strategy for Worldwide Clinical Trials, Aman Khera, discusses how the race to treat COVID-19 will change regulatory forever and what should stay the same.

COVID-19- pharma's black swan moment

The COVID-19 event has provided us in pharma research with incredible opportunities while simultaneously challenging the industry’s status quo. A recent count indicated the number of global studies targeting the SARS-CoV-2 virus to be approaching 1,000, with more than 17 million patients. New safety measures in alignment with social distancing practices add new constraints to ongoing trials in all indications, and sponsors are coming to us with many new questions about their ongoing trials in non-COVID indications.

This is surely a black swan moment in the history of regulated pharmaceutical development. This catalyst for change is destabilizing indeed, but it is also timely. We have had solutions waiting in the wings to address these current challenges; now we have an event that makes their deployment imperative.

How will the race to treat COVID-19 change regulatory for good?

In the face of the COVID-19 pandemic, regulatory agencies around the globe are expediting processes and engaging in increased collaboration with CROs and sponsors. Some of these current regulatory measures, intended to mitigate risks posed by the novel coronavirus to the global population, are undoubtedly temporary. However, we are all learning new speed and efficiency lessons. Once we demonstrate our capacity to operate in this more streamlined way, there will be the demand from patients and advocacy groups to maintain these standards.

Patient engagement gets a huge makeover. Social distancing measures have forced us to rethink our protocols with respect to patient burden. It used to be that patient assessments were not only taken for essential safety and efficacy but also included other potentially useful but nonessential data. The number of patient site visits didn’t have to be limited. Now, researchers must determine what information is needed and consider how to minimize patient burden by shifting to a virtual visit model for trial participation. Once this leaner process is in place and proven to work, it should then become standard practice.

Virtual solutions become imperative rather than optional. The industry has had access to approved electronic solutions for clinical trial processes for half a decade, yet many have remained reluctant to deploy them in their studies. Social distancing measures have made virtual solutions the only option for those wishing to maintain continuity of their clinical trials. Early adopters of these technologies are now able to pivot much more easily. Those who have been resistant to tech innovations are finding that they must adapt to avoid being left behind. 

Regulatory agencies move toward more collaborative engagement. This COVID-19 event has been an occasion of improved interagency collaboration and increased engagement among regulatory, sponsors, and CROs. We are seeing regulatory guidance and recommendations coming with increased frequency, some even being published or updated weekly. The ICMRA Update from April 16 reveals an ongoing evolution of unprecedented knowledge sharing among global regulatory agencies. While many of the current collaborative practices may be in place only for the duration of the pandemic, the precedent has been set for increased collaboration.

What should stay the same?

Regulatory agencies exist for the protection of patient safety, and any changes proven to be better for the patient must become standard practice. As we anticipate a time when we resume “business as usual,” we must assume that there will be no turning back of the clock on our efficiency gains and patient engagement improvements. As we change and adapt, the priority that remains constant throughout this period of sudden and extreme change has to be patient safety. After all, this is why regulatory agencies exist in the first place.

About Aman Khera

Aman Khera, Global Head of Regulatory Strategy at Worldwide Clinical Trials, has been providing global strategic direction in regulatory affairs for more than two decades. She has built her career on maintaining fastidious patient care with the pragmatism needed to help clients achieve effective regulatory strategies. Aman is available to consult with companies of all sizes, as well as their funding entities, to support their goals – with the primary aim of serving humanity as a whole.

If you’d like to learn more about Aman or talk with her about your specific project, you can contact her here. She is just one of many reasons why Worldwide Clinical Trials is the Cure for the Common CRO.