What has COVID-19 taught the clinical trial sector?

When COVID-19 spread across the globe in early 2020, the race began to develop a vaccine to combat the onslaught of the virus.

The pandemic put immense pressure on researchers, regulators and policymakers, who had to act safely and quickly in a time of uncertainty. The research community’s response to the pandemic highlighted many problems with the current system. The problems, and how they were addressed, have taught the clinical research industry several critical lessons:

Transparency and sharing of data
The commercial world of drug development, as well as GDPR/Data Protection and patient protection legislation, block the sharing of trial data.

This practice, however, is detrimental to the scientific process. Secure and anonymised access to patient data could allow other researchers to validate study outcomes and conduct secondary analyses independently.

For example, a trial investigating a therapy for COVID-19 – or another condition – may be limited in its scope regarding the drug’s efficacy on specific demographics. In allowing secondary analyses, data from complimentary trials could be used to investigate the drug’s effectiveness in different populations.

Alignment of processes and standards
Sharing of data can be extended to sharing of practices and operational information. There are common risks to all clinical trials, the same legislation applies to studies in any given territory, we all have a given set of technologies, sites and service vendors to work with. But despite all this commonality, it would be difficult to find two sponsors that exchange useful, but non-competitive information about sites or Providers to address these risks.

So it’s hard for trial sponsors to know what is best practice, without relying on staff knowledge and experience. Imagine how much more efficient the clinical research industry could be if trial sponsors could align their processes to recognised standards, rather than work out for themselves how best to comply? At Clinicology, we ensure best practices are shared across our organisation to promote efficiencies.

Greater diversity is required
The pandemic underscored the disparity of patient groups within clinical research. One study found that ‘female participants were underrepresented in treatment trials, Asian and Black participants were underrepresented in prevention trials, and Hispanic or Latino participants were overrepresented in treatment trials’.

Moving forwards, clinical research must prioritise patient centricity, and introduce practices aimed to improve diversity and inclusivity for under-represented populations. In addition, recruitment and retention can be boosted by engaging with patients regularly during the trial.

Benefits of digitalisation
The pandemic demonstrated the value of technology by helping to boost participation and maintain enrolment in existing trials. For example, remote monitoring enabled data collection and allowed clinical researchers to conduct decentralised or hybrid clinical trials.

Increased use of eClinical technologies such as telemedicine, ePRO, eCOA and virtual healthcare visits can make clinical research more efficient and increase patient recruitment by reducing the burden of travelling to sites.

Fast-tracking therapeutics
The World Health Organization and the European Medicines Agency issued guidelines for accelerated approval of therapeutics, such as those for the treatment of COVID-19. The U.S. Food and Drug Administration also implemented an Emergency Use Authorization process for certain therapeutics.

The rapid development of COVID-19 vaccines was a significant achievement, but this fast-tracking of therapeutics has raised some concerns about safety and efficacy. As we can see from the development of COVID vaccines, ongoing monitoring and post-approval studies are necessary to ensure the safety and efficacy of fast-tracked therapeutics.

Conclusions
Necessity is the mother of invention. In our daily lives we addressed the challenges of lockdowns with newer technologies and alternative ways of working, shopping and even spending our leisure time. Some things in our lives are no longer the same as they were before COVID. But the same challenges forced the clinical research industry to adapt earlier processes, sometimes with the assistance of new technologies for increased efficiencies.

At Clinicology, our experience in decentralised and virtual trials using our own network of mobile research nurses provides us with the opportunity to carry out clinical trials in a post-COVID world. Together, we must learn from the lessons of the COVID era and work to improve clinical research with shared goals.

Sources:
https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(20)30542-8/fulltext#seccestitle140
https://www.ifpma.org/resource-centre/diversity-and-inclusion-in-clinical-trials-bioethical-perspective-and-principles/
https://scopeblog.stanford.edu/2020/11/23/what-covid-19-has-taught-us-about-clinical-trials/
https://clarivate.com/blog/regulatory-response-to-the-covid-19-pandemic-fast-tracking-therapeutics/