Not long ago, the concept of a decentralized clinical trial (DCT) was outside the paradigm of possibility. You couldn't ensure the integrity of a study from a distance, and the idea of decentralization went against the principles of safety and precision in medical research.

It didn't take long for that to change, though.

Fast-forward three decades, and distance between scientists and participants is no longer a limiting factor in many clinical trials, potentially transforming how researchers conduct future investigations.

In this article, we'll explore the recent history of decentralized trials, how the pandemic accelerated their evolution, and why decentralization may be the future of clinical research.

TABLE OF CONTENTS

1. Decentralized Clinical Trials Before the Pandemic
2. COVID-19: A Game Changer for Decentralized Trials
3. 2020 to 2022: DCT Activity Fluctuates
4. 2023: DCTs Regain Momentum
5. Challenges in DCT Implementation
6. The Five Keys To Overcoming DCT Challenges
7. What To Expect by 2025
8. Shape the Future of Clinical Research with Studypages

Decentralized Clinical Trials Before the Pandemic

Traditional clinical trials date back thousands of years, but decentralized trials are a relatively new phenomenon.

The idea was conceived a little over two decades ago, with Pfizer conducting the first-ever fully decentralized trial in 2011. Over the following decade, several other major companies, such as Novartis, GSK, and McKesson, also ran decentralized trials. However, despite the growing opportunities and advancing technology, many still didn't consider decentralized research ready for the mainstream.

COVID-19: A Game Changer for Decentralized Trials

The COVID-19 pandemic dramatically accelerated the adoption of the decentralized model.

Overnight, decentralized data collection and monitoring went from a long-term aspiration to an immediate need. The global emergency forced the healthcare community to take the idea seriously and immediately begin laying the groundwork for adoption.

In October 2020, Boston-based researchers began one of the first decentralized clinical trials to combat the pandemic. Despite a staggering 97% of the respondents never having participated in clinical research, the study sported an 84% to 100% compliance rate, along with promising results.  A study we partnered with showed the effectiveness of DCTs to expand trial access during the pandemic. The study, known as Goals for Reaching Optimal Wellness (GROWell), was originally planned as a hybrid trial but was switched to fully remote due to the pandemic. By utilizing digital trial technology, including Studypages’ HIPAA-compliant, web-based platform to deliver a participant-centred experience, the study was able to achieve up to 82% completion rates.

We also had similar results with another study during the pandemic. Termed the DeTAP (Decentralized Trial in Afib Patients) study, researchers wanted to evaluate DCT feasibility for atrial fibrillation (AF) patients on oral anticoagulation (OAC). They used digital trial technologies, including our Studypages platform, and were able to achieve rapid recruitment of 94 patients in 12 days with over 300 waitlisted! The study also achieved high engagement rates with 91% televisits, 99% ECG and 99% BP measurement completion.

The swift adoption of DCTs in late 2020 and early 2021 was effectively a proof of concept for the viable implementation of a more widespread DCT model.

2020 to 2022: DCT Activity Fluctuates

By the second year of the COVID pandemic, the healthcare industry had begun to stabilize, with DCTs becoming central to success in the new paradigm. By the end of 2021, the number of decentralized trials had passed 1000, eclipsing the number in the previous year by 50%.

However, 2022 saw a 9% decrease in DCT activity. Although the overall numbers were still higher than in 2020, this unexpected decline raised questions about the viability of DCT adoption. Digital data collection, a key DCT component, also decreased in 2022 but was expected to recover in 2023.

2023: DCTs Regain Momentum

The dip in DCT uptake was short-lived. According to a report by ClinicalTrialsArena, 2023 was projected to see a 17% increase in DCT activity, surpassing 2021 numbers to mark the peak in decentralized trial activity.

On June 20th, 2023, the Food and Drug Administration (FDA) released its first-ever draft guidelines for conducting decentralized clinical trials. Eight days later, the European Medicines Agency (EMA) released a similar guideline, and by winter of last year, the Canadian Institute of Health Research had followed suit.

These are important milestones and clear indicators of the direction in which clinical trials are headed. Such guidelines not only help make DCTs a mainstream research practice, but they're also incredibly beneficial in helping researchers overcome the challenges of decentralized trial implementation.

Challenges in DCT Implementation

In many cases, DCT implementation during COVID happened suddenly, making it much more challenging. However, with the pandemic safely in the rearview mirror, researchers now have more time to plan decentralized trials better.

Navigating the wide range of challenges in DCT implementation is central to the model's success, and here are some factors researchers must consider:

• Ensuring the data collected is accurate
• Keeping private health information secure
• Overcoming connectivity issues on both ends
• Maintaining trial participant retention
• Installing digital infrastructure
• Providing sufficient training and support to staff
• Fostering diversity and inclusion in trials
• Coordinating across non-traditional sites
• Complying with evolving regulatory requirements
• Managing shifting industry stakeholder perspectives

The Five Keys To Overcoming DCT Challenges

Fortunately, the growing popularity of decentralized clinical research means there are already solutions to the previously discussed challenges, with plenty more on the way.

We can break these solutions down into five broad categories:

Technology

Emerging technologies represent the most effective tool in overcoming many traditional obstacles in DCT implementation. However, this can be a double-edged sword as technology also creates potential vulnerabilities in data security, making it critical to leverage new advancements responsibly.

Diversity Needs

Emphasizing diversity in clinical research is another factor that is critical in ensuring trial outcomes represent varied demographics, affecting how research findings impact the broader population.

Regulatory Clarity and Consistency

Regulatory bodies must provide clear guidelines for DCT researchers to comply with and update them as statutes evolve. This helps ensure data integrity and patient safety.

Stakeholder Engagement

All stakeholders—including researchers, trial participants, healthcare providers, and regulatory bodies—must be committed to the DCT process and align their goals and expectations.

Training and Education

Finally, all participants must receive comprehensive training and education, especially concerning the use of new technologies and adherence to protocols.

What To Expect by 2025

Considering traditional clinical research's high costs and modest success rates, a more substantial shift toward decentralization can't come soon enough.

We already know that technology will play a substantial part in the future of DCTs, and various companies are already making strides in decentralized clinical research in artificial intelligence (AI) and machine learning (ML). The American Cancer Society has also published a commentary and call to action for making decentralized cancer clinical trials a reality.

What does this mean for DCTs in 2025?

We can't be certain, but Pamela Tenaerts, Chief Scientific Officer at Medable, is extremely hopeful when she says, "By this time next year, decentralized clinical trials will simply be clinical trials."

Whether she's right remains to be seen, but things are trending in that direction.

Shape the Future of Clinical Research with Studypages

Studypages doesn't just report on the latest in health trials; we're helping shape the future of clinical research.

As the popularity of decentralized trials peaks, so will opportunities to be part of those changes. Whether you want to participate in an active trial or need better clinical trial management, our versatile, intuitive platforms provide the answer.

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