Dubai

Background

Clinical research remains the backbone of drug development and evidence generation. The ongoing COVID-19 pandemic in many ways has highlighted the impact clinical trials (CTs) can have on human health. It has brought clinical research to the centerstage from a lay public perspective, in light of accelerated development of several vaccine candidates against SARS-CoV-2 with their potential impact on public health, and the ongoing search for newer therapies or new uses of marketed medicines to manage COVID-19.

Impact of COVID-19 on Clinical Research

It is known that the COVID-19 pandemic caused major disruptions to clinical trial (CT) conduct across the globe beyond any doubt. It is estimated that 80% of non-COVID-19 trials were stopped or interrupted because of the pandemic. The temporary halting of in-person visits and redirection of resources across hospitals, pharma companies and vendors have unavoidably constrained studies in therapeutic areas other than COVID-19. In a nutshell, the pandemic has placed a tremendous strain on the entire clinical research enterprise.

While there was disruption, it also brought renewed focus on finding more efficient ways to conduct CTs. The obvious option for the industry was to explore newer/ emerging technologies to address the numerous constraints and mitigate risks. A recent qualitative study by Tufts Center for the Study of Drug Development assessed the impact of COVID-19 on CT execution, involving 25 companies in the US. In addition to many other findings, they found that Telemedicine and eConsent were the most frequently mentioned technologies adopted. ePRO (patient reported outcome) was the next most frequently utilized technology.²

Many experts also believe that overall, remote technology adoption was more extensive than adoption of remote services (e.g. just IVRS).

COVID-19 as a Catalyst for Digital Transformation

There is no doubt that the digital transformation wave is changing the world. Digital technologies continue to disrupt nearly every industry and health care is no exception. Many industries have seen rapid adoption of technology and subsequently disruptive innovation in the last few years. This can be attributed to the advent of Internet of Things (IoT), or to mobile phone connectivity which has brought consumers very close to technology- in fact everything virtually in their pockets or hands.

Certain industries such as the pharma and clinical research industry were relatively slow in adoption of technology due to many reasons, mainly regulatory, and data privacy concerns. But the pandemic has acted as a catalyst for adoption of technology at an accelerated pace and there are several examples of embracing technology to address the challenges and risks that the pandemic posed to clinical research.

How Digital Transformation happened?

While the industry has been striving to incorporate certain digital health technologies into study design in the last few years—such as mobile devices, mobile apps, remote monitoring devices, and online social engagement platforms—the progress hasn’t been optimal.

The pandemic in a way has acted as a catalyst. Increasing number of pharmaceutical companies and more importantly the regulatory bodies (e.g. US FDA, EMA) are realizing the paradigm shift. They are becoming more open to new CT methodologies and tools, direct to patient drug shipment including self-administration at-home dosing, more patient-centric study designs, remote data collection and telehealth touchpoints. Innovative technologies – such as inexpensive sensors, embedded wearables, GPS, more ubiquitous WiFi connections and cloud-based data integration – are enabling easy, real-time, automated data capture and reporting.

An interesting aspect of the digital transformation that is underway is that there is more focus on patient- centric approaches in CTs. A shift which brings the CT to the patient instead of the patient coming to the trial.

A recent survey by Oracle, showed that 76% of 252 industry respondents noted that the pandemic sped their adoption of decentralized CT methods. The most common decentralization steps taken were patient-facing technologies or alternatives (64%), protocol redesign (63%), and investigator-facing technologies or alternatives (53%).³

In the pre pandemic era, the efforts of the clinical research industry were largely focused on digital replacement of existing standards—screens in place of paper— even though the more critical need is for a digital redesign of processes and workflows. But this is changing given the challenges the pandemic brought. Digitalization plans which were part of multi-year plans had to be accelerated for implementation in much shorter time span. The question therefore arises what is the need for this change, why now?

Need for change- why now?

While one could list many more reasons, some experts have identified three key reasons why now is the time to restructure the CT paradigm for pharma (source: https://www.bvp.com/atlas/drugs-in-a-virtual-world-the-rise-of-digital-health-solutions-in-clinical-trials):

Preferences of clinical research participants are changing

Cost-effectiveness and trial efficiency are paramount in a time when COVID-19 places additional financial pressure on drug developers.

The regulatory landscape is changing, though slowly, encouraging the adoption of virtual CTs

Clearly there are opportunities for innovation across the CT value chain. As a recent article in Nature pointed out, a complete re-thinking and re-engineering of the CT experience around the participant rather than the research site is needed.⁴

Conclusion

While the pandemic has disrupted clinical research in therapeutic areas (other than COVID-19-related), the COVID-19 response has also introduced innovations that have advanced / brought a paradigm shift in overall conduct of clinical research. In many ways the pandemic has reset the expectations that will frame the environment for conducting CTs post- COVID-19.Experts predict that post-pandemic digital capabilities for decentralization will become a critical component of successful clinical.

Disclaimer: The opinion expressed in the article is that of the author in his person capacity based on experience and doesn’t represent the view of the employer.