It’s impossible to deny how different clinical trials look almost four years after the pandemic revolutionized clinical research. Today, the digital and decentralized tools and technologies that enabled clinical trials to carry on through the COVID-19 pandemic are present (in some form) in nearly all clinical trials, a far cry from the dynamics of 2019.
Both the FDA and EMA have embraced capabilities that were initially categorized as “DCT (Decentralized clinical trials)”. Earlier this year, the FDA and EMA issued much anticipated regulatory guidance around decentralized clinical trials and their technologies.
As a result, modern clinical research technologies like eConsent, eCOA, and telehealth are poised for impressive growth. According to a report from Research and Markets, by 2030 the:
- eConsent market is set to jump from $81.3 million to $295.7,
- eCOA market is on track to grow from $601.9 million to $2.5 billion, and
- Telehealth is predicted to go from $285.1 billion to almost $1.2 trillion.
TransCelerate’s “modern clinical trial”
TransCelerate, a non-profit organization dedicated to accelerating the development and delivery of new medicines and vaccines, has released a new definition of the "modern clinical trial." The definition is as follows:
A modern clinical trial is a research study that uses innovative technologies and approaches to improve the efficiency, effectiveness, and patient experience of clinical research.
The definition includes the following key elements:
- Use of innovative technologies: Modern clinical trials use innovative technologies to improve the efficiency and effectiveness of clinical research. This includes technologies such as eConsent, eCOA, and telehealth.
- Focus on the patient experience: Modern clinical trials focus on the patient experience and aim to minimize the burden on patients. This includes using patient-centered design principles and providing patients with support and resources.
- Collaboration: Modern clinical trials involve collaboration between industry, academia, and government stakeholders. This collaboration is essential to accelerating the development and delivery of new medicines and vaccines.
“Decentralized” aspects are now the default
Throughout the 20th and 21st centuries, the ways in which human beings interacted with countless industries evolved into new and sometimes foreign experiences.
For instance, the banking industry has undergone a significant transformation throughout the last decade, becoming increasingly consumer-friendly thanks to the rise of online banking and other digital technologies. In the past, banking was a time-consuming and inconvenient process, often requiring customers to visit a physical branch during business hours. Today, customers can access their bank accounts and perform a wide range of banking transactions from anywhere in the world, at any time of day or night.
Much like banking, today’s clinical research participants often have the ability to submit data, check on their trial progress, consent, and speak with trial investigators from the comfort of their own homes. As Transcelerate notes, the combination of collaboration between trial stakeholders and innovative technology enables a better, more consumer-like experience for trial participants.
Medable’s continued approach
Since our founding in 2015, Medable has been committed to improving the clinical trial experience for sponsors, CROs, clinical sites, and participants. As a pioneer of decentralized clinical trials, and the number one rated DCT provider for two years in a row according to Everest, we understand the impact and importance of continual evolution.
Whether the industry calls them decentralized, hybrid, digitally enabled, or modern clinical trials, we’ll continue to provide the ability to design and execute more efficient clinical trials to help bring treatments to patients faster.
Medable’s approach will remain steadfast in bringing new processes, approaches, and technologies to the forefront of clinical research. Our mindset in doing so echoes that of Transcelerate CEO Janice Chang when she recently stated the following.
“There is a real opportunity, particularly post-COVID, to further advance clinical trial trials and leverage what we’ve learned and proven that can be done.
As an industry, we must always focus on how we can continue to advance in a pragmatic way.
We must look at who are the stakeholders that need to be at the table. We must examine new models that are evolving in clinical research”
To learn more about Medable’s clinical trial platform and the capabilities of modern clinical trials, click here.