The COVID-19 pandemic has been the single largest factor in changes in clinical trials, impacting the processes to achieve them, the people who take part in them, and the technologies that are evaluated. Over the past few years, the world has seen the massive benefits of clinical trials through booming medical innovation that helped to diminish the danger of the pandemic, but those benefits are also applicable far outside the realm of COVID-19. There has been a distinct shift in the values of the clinical trial industry, pushing the patient to the center of focus as they continue to increase their own awareness of their health and well-being, including their medical treatments. Much of the innovation and creation that emerged as a result of the COVID-19 pandemic has given the patient a more prominent voice throughout the clinical trial process and enabled them to take a larger role in the process.
2023 Clinical Trials Trends
Trend #1: Digital Transformation: Technologies to Support Decentralization
Decentralization of clinical trials has been a continuing trend since the start of the pandemic in 2020. Decentralized trials have proven to be a successful method of trial delivery in the past several years; however, it has demonstrated a technological gap that is now being filled to support further decentralization.
Evolving innovations are becoming the core of clinical trials in a way never possible before, and clinical trials are struggling to keep up with the ever-changing digital technologies. Passive data collection, such as wearable devices that can track heart rate, blood pressure, oxygen, and much more, are starting to be incorporated into clinical trials to collect a vast range of data over long periods of time, improving trial accuracy and increasing the speed at which the trial can be completed.
Mobile applications are also being utilized to create a single resource for patient interaction, which increases patient clarity in trial functionality as well as compliance. Direct-to-patient shipments decrease compliance burdens and increase patient participation, and virtual visits with physicians allow patients to participate from far away from trial sites. These are only a few examples of the creative innovations that the clinical trial industry has taken to navigate this decentralized model while still achieving their goals.
While this evolving climate has major advantages for clinical trials, it leaves a gap in compliance for the FDA to fill. As a result, the FDA is implementing remote regulatory assessments (RRA) to evaluate documentation and ensure conformation with FDA data regulations. Sponsors must be able to prove that data is secure, reliable, and consistent, all while de-identifying patient information to retain privacy in order to pass these assessments.
It’s essential to note that the success of the implementation of new technologies is dependent on the ability of human resources to keep up with these changes. This is a massive undertaking with respect to training, IT services, and execution, and the skills and mindset of employees will determine the efficacy of these changes. These resources must be fully equipped to adapt to these innovations through the implementation process to execute these technologies effectively and stay ahead of the ever-changing technological landscape. Continue reading by downloading the full report below.
Read last year’s Clinical Trials Trends Report here.
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Contributions from Sophie Heiman and Randy Martinez