Today, we celebrate Clinical Trials Day 2021! The day of awareness is an opportunity for research teams, patients, and the public to recognize how clinical trials have shaped modern medicine. It’s also a chance to reflect on how far we’ve come – and the amazing impact clinical research has made – on our understanding of diseases and their causes, treatments, and prevention.
Historical Trends in Clinical Trials and Technology
We only need to look back twenty years – when Mednet was founded – to see the incredible growth, change, and progress made in the clinical trials industry.
We founded Mednet in 2001 – at the time, the industry was just beginning to explore the transformation from paper-based clinical trials to trials leveraging electronic automation for labor-intensive, manual tasks such as data capture. When we brought our web-based solution to market, our discussions with customers were focused on the potential for technology, specifically electronic data capture, to streamline many clinical research processes. Many customers were concerned about security and the elimination of known processes like double data entry.
In their early forms, many clinical trial technologies were developed as point solutions focused on specific tasks to reduce the potential for human error and improve the quality and timeliness of data. However, these point solutions only targeted tasks, not processes. At the same time, many still required heavy development work to build individual studies. As technology evolved, we ultimately recognized the need for a self-service model, launching iMednet, enabling customers to build their own studies too.
As technology became more and more widely used in both healthcare and clinical research, the rapidly evolving industry recognized the opportunity to connect points of automation. This more holistic approach promised greater time and cost savings and improved quality of clinical trial data. In some cases, this shift required the integration of numerous disparate systems. These massive and complex integration projects became the foundation for what we call today “a platform approach”. This approach is exemplified in today’s version of iMednet, a comprehensive platform, built with native modules while also allowing for integrations of other clinical research technologies.
The platform approach has given clinical trial teams the ability to access data from multiple simultaneous processes and make quicker, more accurate decisions based on that data. The advent of SaaS-based solutions broadened access and offered greater transparency into ongoing trials.
As web-based solutions grew, so did the number and types of data sources. Wearables and the Internet of Things (IoT) increased by orders of magnitude. Sponsors began to incorporate them into trials to ease the patient reporting burden, streamline processes and increase insights through real world evidence (RWE).
Clinical Trials Today
In the past twenty years of clinical trials, probably the most rapid and significant changes occurred in the past year. While the COVID-19 pandemic initially slowed clinical trials, it also motivated research teams to quickly develop and adopt new and innovative practices. These practices supported research objectives while recognizing and respecting regional lockdowns, participants’ lack of ability/interest in visiting trial sites and key roles like monitors needing to perform their work remotely. The pandemic forced the industry to take a huge leap toward decentralized trials that likely wouldn’t have happened – or at least it would’ve been much slower – under normal circumstances.
Fueled by the COVID-19 pandemic, we have witnessed a massive shift toward hybrid and decentralized trials. In recognition of Clinical Trials Day, Sanofi issued a statement that reflects the current trend in the industry. The statement reads, in part:
“In early 2020, we included standard wording in our protocol template that allowed us to implement Decentralised Clinical Trial activities rapidly. That has helped us continue to keep our clinical trials–and therefore the business of our sites and the care of our patients–moving.”1
As decentralized trials grow in number, we are also seeing a notable shift in the role of the patient. The industry has begun to recognize the value of the patient voice throughout the planning, design, and conduct of clinical trials. This awareness is shifting how researchers recruit and engage patients and how they communicate with trial stakeholders and their public audiences.
Looking Ahead to Clinical Trials of the Future
As clinical trials continue to evolve, we see great opportunities to incorporate emerging technologies such as artificial Intelligence (AI) and natural language processing (NLP). These types of technologies promise to improve trial performance and the patient experience.
Innovative trial designs, new data sources, and emerging technologies will continue to add complexity, speed up processes, and motivate constant innovation.
Throughout the whirlwind of change that has marked the last twenty years, the Mednet team has continued to partner with our customers to optimize their clinical research projects. On Clinical Trials Day 2021, we recognize the researchers and trial participants who motivate us to deliver industry-leading clinical trial technologies along with world-class support services every day.