Propelling clinical research into the 21st century

Two and a half years ago, Covid-19 began to infect hundreds, then thousands, then millions of people, and was eventually declared a global pandemic. Lockdowns and 25-second handwashing, face masks, home-schooling, and working from home became the new normal. The term “social distancing” entered into common parlance and we transitioned to a life largely spent at home.

Thankfully, the world has mostly returned to normal and the virus will hopefully be a thing of the past in the near future. The pandemic leaves myriad economic, social, health, and psychological scars in its wake. It caused intense suffering and tragedy. But adversity and hardship sparks creativity, ingenuity, and defiance, resulting in great leaps forward. A renaissance in vaccines research is just one example of something good to come out of the pandemic.

For the clinical trials industry, the pandemic forced new ways of working and fresh ways of thinking about clinical research and how to conduct it remotely. The alternative was unthinkable: halting all clinical research to the detriment of patients who so desperately need new medicines. It prompted widespread adoption of regulatory change and technological advances that might otherwise have taken decades.

At Medidata, a Dassault Systèmes company, we saw these efforts first hand and now, two years on, we have taken stock of where our sector is. Medidata’s recent independent research report surveyed hundreds of clinical trial executives across the United Kingdom, France, Germany, and Switzerland to understand the changes they have witnessed over the past two years and, crucially, whether they believe these changes are here to stay.

Covid-19: adversity leading to improvements

The research highlights the extent to which Covid-19 affected the industry, with 99% of respondents saying the pandemic negatively impacted their ability to conduct trials. Encouragingly, however, nearly all respondents (98%) also said the pandemic improved the way trials are run.

How could a trial be run if participants couldn’t leave their homes to get to the clinic or felt uncomfortable doing so due to the spread of the virus? Companies turned to a few different solutions: better use of wearable technology to monitor patients remotely; allowing patients to take medication at home and using video calls to help them; tracking patients’ function through electronic diaries; and wider adoption of eConsent, to name a few. This not only allowed trials to continue, but also allowed study teams to realise the value of real-world data and data collected continuously in real-time while patients go about their daily activities.

Patient burden can also be decreased by leveraging these technologies - for example, by removing the need to travel long distances to trial sites can improve enrolment, attract people from more diverse backgrounds and reduce attrition. Regulators, in turn, were swift to offer new guidelines to allow clinical trial operators to redesign trials to suit this “new normal”. The combined effect of this will be better data and, ultimately, better trial outcomes.

Covid-19 undoubtedly acted as a catalyst for change in an industry known for being cautious and slow to adopt new ways of doing things. It spurred operational changes and technological advances that have improved both trial efficiency and, most importantly, the patient experience. The three most commonly cited improvements brought about by the pandemic impacted patients, trial sites, sponsors, and partners alike. These included better clinical trial outcomes (37%), better recruitment and enrolment (36%), and better patient experiences (36%). And, nearly all of the experts surveyed (99.7%) said all or some of the improvements to the clinical trial process as a result of the pandemic would remain, highlighting the industry’s willingness to adopt innovative processes and enshrine them as best practice.

The report did, however, flag a few caveats. Half of respondents (51%) said reliance on historical systems and traditional processes could prevent some of these changes from becoming permanent. This underscores the need for stakeholders across the industry to work in tandem to identify areas that need to be adjusted or updated to ensure the improvements won as a result of the pandemic are not lost. Nearly half (47%) of those surveyed suggest that patient preferences may be a potential barrier. This suggests the industry may need to invest in educating patients on the new tools and ways of working and how these can lessen the burden on them and, in turn, improve their overall experience.

Technology driving patient-centric practices

One of the principal technological shifts over recent years has been the adoption of decentralised clinical trials (DCTs) - where the use of remote and digital technologies can improve trial efficiency and reduce patient burden. According to respondents, the use of DCT technologies is set to continue to grow: while around 43% of clinical studies were using at least one decentralised technology before the pandemic, this figure has now increased to 55% and is expected to climb further to 66% in the next five years. This is leading to benefits across the industry in terms of improving compliance and governance adherence (42%), improving patient recruitment and retention (41%), and improving patient experience and overall engagement (41%), according to respondents.

The survey also revealed that, while the pandemic sped up adoption of DCTs, the digital shift was already underway in Europe before the pandemic, but at a slower pace. More than 90% of respondents stated that their country was either a ‘global leader’ or ‘early adopter’ in using technology in clinical trials, with 92% saying that trials in their country always or frequently rely on technology.

There was also a strong focus on patient centricity, with 92% of respondents believing that clinical trials are now more patient-centric than ever. This is hugely encouraging, but there is still work to be done. Many respondents said there were still barriers to making the clinical trials process more patient-centric. While respondents in the UK pointed to regulatory restrictions as the biggest barrier (59%), those in Switzerland and Germany said there was still a perception that sites and researchers were resistant to changing clinical trial conduct (52% and 50%, respectively). Respondents in France, meanwhile, cited a lack of engagement with patients post trial-completion as a barrier to true patient centricity (46%).

The findings suggest that the entire clinical trials industry - from regulators and sponsors, to sites and researchers - need to continue to collaborate and embrace change and innovation in order to ensure that we continue to improve the patient experience and, ultimately, trial outcomes.

Maintaining the momentum

This research offers a valuable snapshot of the current clinical trials landscape, two and a half years since the pandemic hit. It suggests unprecedented progress has been made in a short amount of time and the enormity of the innovation and rapid uptake in technology that has occurred over the past two years should not be underestimated. But it also serves as a reminder that there is still work to be done to ensure that the positive momentum spurred by the pandemic is not lost or side-lined. We must continue to drive improvements across the clinical trials process, to embrace technology, new ways of working, and push for regulatory changes because that will result in better data and better trial outcomes for the patients we serve, allowing us to get life-saving drugs to those who need them most. The opportunity is here, let us not squander it.

About the author

Pete Buckman is SVP at Medidata. He manages the professional services teams in Europe and Asia and is site leader for EMEA. He is responsible for growth, organisational structure, and delivering the Medidata Clinical Cloud Platform and services for many pharmaceutical organisations, biotechs, and clinical research organisations, as well as academic and non-profit organisations alike.