For years, clinical trials have been the backbone of medical progress, allowing researchers to test the safety and efficacy of new treatments. In 2020, the COVID-19 pandemic threw a curveball at this process. In the early months of the pandemic, new patient enrollment in clinical trials plummeted by a staggering 70% compared to previous years, resulting in a global slowdown — a near 30% decrease in new subjects entering trials by June 2020.¹ Since the height of the pandemic, enrollment challenges have lingered to various degrees worldwide.

In this post, we’ll explore the effects of COVID-19 on clinical trials and how innovative approaches, such as Real World Evidence (RWE) platforms and hybrid trials, can help drive progress in clinical trial enrollment while helping maintain patient-centricity.

The Challenges of Traditional Trials
Even before a pandemic exposed and worsened their vulnerabilities, traditional clinical trials faced challenges, including:

• Slow Enrollment: Strict criteria can limit eligible patients and delay trials.
• Limited Diversity: Some trials struggle to reflect real-world populations, hindering generalizability.
• High Drop-Out Rates: Inconvenient visits, side effects, or health changes can reduce usable data and weaken findings.

Studies documented a staggering 76.8% year-over-year drop in new patient clinical trial enrollment during the peak of COVID-19.  Concerns about safety, limited clinic access, and logistical disruptions all contributed to this decline, creating a backlog of trials that persisted even as of March 2022.² With patient enrollment at record lows, the pandemic highlighted trial limitations and prompted a paradigm shift in clinical research. Today, there is a more widely recognized and urgent need for innovative solutions to make clinical research more efficient, adaptable, and inclusive.

Rethinking the Model: Decentralized Trials and Patient Centricity
Clinical trial reform is gaining traction as research teams seek a more flexible and patient-centered approach.

A patient-centric approach puts the needs and well-being of participants at the forefront, which means involving patients in the design and execution of trials, ensuring clear communication throughout the process, and offering flexible participation options such as hybrid or virtual trial environments.³ In this way, researchers help mitigate roadblocks such as high drop-out rates and slow enrollment.

One solution currently gaining momentum is decentralized clinical trials (DCTs), which promote patient-centricity by design. These trials break down geographical barriers and help reflect real-world populations by allowing patients to participate remotely through telehealth visits, wearable devices, and home-based sample collection. Direct-to-patient engagement optimizes patient retention and participation throughout the clinical trial life cycle. This strategy can significantly improve enrollment rates, especially for dispersed populations or those with limited mobility.

Real World Evidence (RWE)
Leveraging existing patient data from electronic health records and other sources can be a powerful tool alongside any trial model. A recent Medical Marketing and Media article noted an accelerated awareness and adoption of RWE following the COVID-19 pandemic. Quality RWE has the power to expedite patient enrollment by identifying potential participants who meet trial criteria, inform study design by providing insights into real-world treatment patterns and patient outcomes, and uncover previously unknown drug interactions. Despite its incredible potential, challenges remain in properly aggregating and utilizing RWE data.⁴ Companies need robust data collection, management, and analysis solutions to ensure the quality and reliability of RWE for clinical research.

EmpiraMed’s Solution for Streamlined Research
EmpiraMed’s technology operationalizes any protocol to more readily deploy site-based, site-less, or hybrid clinical trials and collect quality RWE data. The platform offers several key features that make it specifically well-suited for hybrid and virtual trials:

• DCT & Registry Execution: The system provides a central hub for managing all aspects of registries and decentralized trials, including patient recruitment, data collection, and communication.
• Participant Data Capture Software: The software allows patients to self-report data directly into the trial database.
• Participant Incentivization: The platform includes a gamification and incentivization system designed to increase engagement and retention — boosting participation rates by more than three times the industry standard.⁵
• EHR Inclusion: EmpiraMed’s platform can integrate with participants’ electronic health records (EHRs) to collect relevant medical data without clinic burden or contracts.
• 360-Degree View of the Patient: EmpiraMed’s platform integrates data from multiple sources to provide a more holistic view of each patient’s health.

The platform’s features combined to pave the way for clinical research teams to gather higher-quality data and richer insights over time.

As healthcare ecosystems adapt to leverage patient-centric digital health technologies, newer and sophisticated tools like AI and machine learning will be crucial to fuse quality RWE to advance clinical research and precise decision making.

About EmpiraMed
EmpiraMed is a pioneer in digital clinical technology that utilizes flexible and configurable plug and play modules in a unified cloud environment to capture Real World Evidence for site-based, site-less, or hybrid projects. EmpiraMed provides an ease-of-use, single source platform for sponsors, participants, and clinicians. For more information visit www.empiramed.com or contact us at info@empiramed.com / 978-344-4300.

About Court Square Group’s Audit Ready Compliant Cloud (ARCC)
Eliminate the complexity and risk of obtaining, deploying, and managing a qualified, validated, and compliant IT environment. With Court Square Group’s Audit Ready Compliant Cloud (ARCC), you can rest easy, knowing your business will be built on the most secure, 21 CFR Part 11 compliant and audit-ready platform by specialists who understand the nuances of your business. For more information visit www.courtsquaregroup.com or contact us at info@courtsquaregroup.com.

References

1. Sathian B, Asim M, Banerjee I, et al. Impact of COVID-19 on clinical trials and clinical research: A systematic review. Nepal J Epidemiol. 2020;10(3):878-887. Published 2020 Sep 30. doi:10.3126/nje.v10i3.31622
2. McDonald K, Seltzer E, Lu M, et al. Quantifying the impact of the COVID-19 pandemic on clinical trial screening rates over time in 37 countries. Trials. 2023;24(1):254. Published 2023 Apr 4. doi:10.1186/s13063-023-07277-1
3. Mahoney ME, Sridhar SS. Clinical trial reform in the post-COVID era. Ther Adv Med Oncol. 2023;15:17588359231183676. Published 2023 Jul 8. doi:10.1177/17588359231183676
4. Fernando S. Real-world data in a post-pandemic world. MM+M – Medical Marketing and Media. Published September 15, 2023. Accessed April 5, 2024. https://www.mmm-online.com/home/channel/features/real-world-data-in-a-post-pandemic-world/
5. Inc E. EmpiraMed – Products & Services. empiramed.com. Accessed April 6, 2024. https://empiramed.com/products-and-services.html