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Propelling clinical research into the 21st century –

by MarketNews
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Two and a half years ago, Covid-19 began infecting hundreds, thousands, and millions of people and was eventually declared a global pandemic. Lockdown and his 25 seconds of handwashing, face masks, homeschooling and working from home have become the new normal. The term “social distancing” has become a common term and we have moved to living primarily at home.

Thankfully, the world has returned to mostly normalcy and we hope the virus will be a thing of the past in the near future.The pandemic has left a myriad of economic, social, health and psychological scars. It caused intense suffering and tragedy. But adversity and hardship inspire creativity, ingenuity, and challenge to make great strides. The renaissance in vaccine research is just one example of the good things that can come out of a pandemic.

For the clinical trials industry, the pandemic has forced new ways of working and fresh thinking about clinical research and how to conduct it remotely. I couldn’t think of an alternative. It has halted all clinical research to the detriment of patients in dire need of new drugs. It has prompted widespread adoption of regulatory changes and technological advances that might otherwise take decades.

At Medidata, a Dassault Systèmes company, we’ve seen these efforts firsthand and know where our sector is now, two years later. A recent independent research report from Medidata surveyed hundreds of clinical trial executives in the UK, France, Germany and Switzerland to find out what changes they have seen over the past two years and, importantly, , was done to understand whether we believe these changes will continue.

Covid-19: adversity leading to improvement

The survey highlights the extent of Covid-19’s impact on the industry, with 99% of respondents saying the pandemic has negatively impacted their ability to conduct clinical trials. But reassuringly, nearly all respondents (98%) say the pandemic has improved the way clinical trials are conducted.

How can a trial be conducted if the spread of the virus makes it impossible or uncomfortable for participants to leave their homes to go to the clinic? Companies are looking at several different solutions. I turned it. Allow patients to take their medication at home and use video calls to assist them. Electronic diary tracking of patient function. Broader adoption of eConsent, to name a few. This not only allowed the trial to continue, but also allowed the research team to recognize the value of real-world data and data continuously collected in real-time while patients performed their daily activities.

The use of these technologies can also reduce the burden on patients. For example, eliminating the need to travel long distances to study sites can improve enrollment rates, attract people from more diverse backgrounds, and reduce attrition. Meanwhile, regulators have swiftly provided new guidelines to help investigators redesign their trials for this “new normal.” These combined effects lead to better data and ultimately better test results.

Covid-19 has undoubtedly acted as a catalyst for change in an industry notoriously cautious and slow to adopt new practices. This has facilitated operational changes and technological advances to improve both trial efficiency and, most importantly, the patient experience. The three most commonly cited improvements brought about by the pandemic have impacted patients, sites, sponsors and partners alike. These include better clinical trial outcomes (37%), better recruitment and enrollment (36%), and better patient experience (36%). Nearly all (99.7%) of the professionals surveyed also said that all or some of the clinical trial process improvements as a result of the pandemic would be maintained, with the industry adopting innovative processes and We emphasize that we are trying to establish them as best practices.

However, the report points out some caveats. Half of respondents (51%) said some of these changes may not be permanent because they rely on legacy systems and legacy processes. This highlights the need for stakeholders across the industry to work together to identify areas that need to be adjusted or updated so that the improvements made as a result of the pandemic are not lost. Nearly half (47%) of those surveyed suggested that patient preferences could be a potential barrier. This suggests that the industry needs to invest in educating patients about new tools and ways of working and how these reduce patient burden and thus improve the overall experience.

Technology that drives patient-centered care

One of the major technological changes in recent years has been the adoption of decentralized clinical trials (DCT). This DCT can improve trial efficiency and reduce patient burden through the use of remote and digital technology. According to respondents, the use of DCT technology will continue to grow. About 43% of clinical studies before the pandemic used at least one decentralized technology, but this figure has now increased to 55% and is expected to rise further to 66%. % over the next five years. According to respondents, this translates into improved adherence to compliance and governance (42%), improved patient recruitment and retention (41%), and improved patient experience and overall engagement (41%). It benefits the entire industry.

The study also revealed that while the pandemic accelerated the adoption of DCT, the digital shift was already underway in Europe before the pandemic, but at a slower pace. More than 90% of his respondents say their country is a ‘global leader’ or ‘early adopter’ in using technology in clinical trials, and 92% say clinical trials in their country always or often rely on technology. It says it does.

There is also a strong focus on patient-centricity, with 92% of respondents believing that clinical trials are more patient-centric than ever before. This is very encouraging, but there is still work to be done. Many respondents said there are still barriers to making the clinical trial process more patient-centric. Respondents in the UK cited regulatory restrictions as the biggest barrier (59%), while respondents in Switzerland and Germany said sites and researchers were resisting changes in the conduct of clinical trials. said they still have awareness (52% and 50% respectively). French respondents, on the other hand, cited the lack of post-trial patient engagement as a barrier to true patient-centrism (46%).

The findings encourage the entire clinical trials industry, from regulators and sponsors to clinical sites and researchers, to continue working together, embracing change and innovation to improve the patient experience and ultimately improve trial results. It suggests that we need to keep improving.

keep the momentum going

This study provides a valuable snapshot of the current clinical trial landscape, two and a half years after the outbreak of the pandemic. This suggests that unprecedented progress has been achieved in a short period of time, and the enormity of innovation and rapid diffusion of technology that have occurred in the last two years should not be underestimated. But it’s also a reminder that more needs to be done to ensure the positive momentum spurred by the pandemic isn’t lost or sidelined. We must continue to drive improvements across the clinical trial process, adopt technology and new ways of working, and drive regulatory change. This will result in better data and better test results for the patients we care for, saving lives. Bringing medicines to those who need them most. Opportunity is here. Let’s not waste it.

About the author

Pete Buckman is Senior Vice President of Medidata. He manages the Professional Services team in Europe and Asia and the EMEA site where he is the leader. He is responsible for the growth, organizational structure and delivery of his Medidata Clinical Cloud Platform and services for many pharmaceutical, biotech and clinical research organizations as well as academic and non-profit organizations.

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