How Pandemic-Era Ingenuity Fuels the Future of Clinical Trials

It’s hard to believe that just five years ago, the clinical research industry found itself scrambling to adapt overnight. The COVID-19 pandemic ground global health systems to a halt and forced us all to move faster and more collaboratively than ever before.

Yet in that disruption was a spark.

As trials were paused or reengineered, new approaches emerged – out of necessity, yes, but also out of ingenuity. Sponsors, regulators, investigators, and patients leaned into virtual visits, remote monitoring, direct-to-patient drug delivery, and decentralized models that prioritized access and safety. What began as a crisis response became a watershed moment for the future of clinical trials.

We stand now at a critical juncture; one where we can transform the lessons of the pandemic into lasting change, making cross-industry collaboration a cornerstone of future innovation.

When the whole industry shifted
 

When I reflect on the early months of 2020, what stands out most is not the speed of change, but the depth of cooperation. The pandemic broke down silos that had long slowed progress. The industry saw unprecedented coordination; not just between sponsors and regulators, but across the entire ecosystem, from CROs and sites to technology providers and patient advocates.

That spirit of collaboration was a catalyst for change far beyond clinical trial design. Regulatory agencies embraced real-time data sharing, adaptive trial designs and rolling submissions. Biopharma companies reexamined long-held assumptions about protocol rigidity, site-centricity and risk. And in unprecedented ways, research began to adapt to patients, not the other way around.

Beyond workflows and timelines, the pandemic ignited a cultural shift across the industry. And perhaps most importantly, it was participatory, in that it brought more patients into the research process.

I think of this paradigm shift as the rise of the “possible trial.” That phrase captures the kind of clinical research model that began to take shape during the pandemic – one that is faster, more flexible, and more accessible to the patients who need it most.

The idea itself stems from visioning work conducted at TransCelerate before I joined the organization, which explored what might be possible if the industry redoubled efforts to modernize trial design and expand access.

During the pandemic, we saw key elements of that vision come to life:

• Decentralized and hybrid trials enabled participation from home or local clinics.
• Electronic consent and telemedicine made onboarding and check-ins safer and more convenient.
• Direct-to-patient drug shipping reduced the logistical burden of frequent travel.
• Digital data capture and remote monitoring allowed for real-time insights without compromising quality.
• Real-world evidence (RWE) played a growing role in protocol design and regulatory decision-making.

These innovations not only allowed trials to continue, but also often improved speed, broadened diversity, and reduced dropout rates. At one major academic cancer center, telemedicine and remote staffing appears to have produced significant enrollment improvements: From March to August 2020, 8.8 percent of new patients enrolled in clinical trials, which was a 10.5 percent relative increase over the same period in 2019. In June and July of that year, enrollment surged 74.1 percent and 45.7 percent, respectively, compared to the year prior.

Others in the healthcare sector worked in new ways, too. For example, some health systems utilized electronic health records (EHRs) to swiftly identify eligible participants for clinical trials. By leveraging detailed demographic and clinical information within EHRs, researchers could efficiently pre-screen patients, reducing the time required for enrollment.

These adaptations also brought clinical research closer to patients’ daily realities. Participating no longer required putting life on hold. For clinicians, it was a chance to expand the trial network beyond large academic hubs and into community care settings. For sponsors, it showed how flexibility could enhance, not hinder, rigor.

A new era of regulatory engagement
 

Few changes were as profound as the evolution of regulatory engagement. Health authorities responded to the pandemic with urgency and pragmatism, often issuing guidance in days or weeks instead of months. They allowed for greater use of RWE, supported decentralized models, and engaged in more frequent dialogue with sponsors to ensure that innovation could proceed without compromising safety.

Rather than relaxing expectations, regulators recalibrated them to respond to extraordinary circumstances. And in that recalibration, we caught a glimpse of what regulatory flexibility could look like going forward. For example, the FDA released guidance on the conduct of clinical trials during the pandemic in March 2020, and updated it multiple times to reflect new learnings and technologies. Regulators across Europe, Asia and Latin America followed suit, in many cases adopting interim flexibilities that allowed remote consent, remote source data verification, and virtual safety monitoring.

Going forward, continued partnership between industry and regulators will be key to shaping when and how these innovations become more widely adopted. Shared learning, mutual trust and patient-centered thinking will help define what progress looks like in this next chapter.

Despite the progress we’ve made, there are signs of backsliding. In some regions, temporary policies that enabled DCTs are expiring, investment in digital infrastructure is leveling off and as the urgency of the pandemic fades, so too does the momentum for bold change.

The progress toward greater access could slip away if we're not vigilant. Without supportive policies, telemedicine becomes harder to implement. Without clear standards, we could see a gradual return to more formalized regulatory procedures.

Falling back on legacy models may not adequately support the patient access and equity standards we now recognize as essential. If patients are again required to travel long distances or miss work to participate in trials, many will inevitably opt out. And if research fails to reflect the diversity of real-world populations, treatments will continue to leave some communities behind.

We have to be careful not to mistake “normal” for “optimal.” The pre-pandemic clinical research model had real limitations: it often excluded patients, moved slowly and relied on processes that were too centralized and inflexible. Today, we have a clearer view of what’s possible—and with that comes an opportunity, and a responsibility, to do better.

Perspective from the inside
 

Before the pandemic, many of us in clinical research talked about the need for more patient-centric trials, greater collaboration and digital transformation. But in reality, turning those ideas into action proved extremely challenging.

The pandemic opened the door to more rapid progress. Urgency stripped away the barriers to change and ignited our collective ingenuity. And along the way, we saw what true transformation looks like.

We also saw the human side of clinical research. Patients enrolling in COVID-19 trials were doing so amid profound uncertainty. Many were isolated, some were frightened. Yet they participated anyway; not just for themselves, but for the good of others.

We owe it to those patients to honor their contribution by embedding the best of what we learned into the future of research. And we owe it to future patients to design a system that welcomes them, wherever they are and whatever their circumstances.

The future of clinical research won’t be defined by one innovation or one policy. It will be defined by our collective willingness to learn from the pandemic, evolve beyond it, and embrace the power of collaboration to establish a new normal across the biopharma ecosystem.

We need to embed our successful approaches, such as decentralized models, regulatory flexibility, data interoperability into fundamental operations. This requires ongoing patient feedback to shape protocols around their real lives, while making our crisis-forged collaboration the new standard for how clinical research works.

What we built under pressure deserves a permanent place in how we do research. We’ve seen the possible trial. Now it’s time to make it stick.