Minimizing Disruption Through Hybrid Clinical Trial Adoption

There have been significant disruptions in the healthcare industry in recent years, particularly in the conduct of clinical trials. The traditional, centralized model of clinical trial design has faced significant challenges in terms of patient recruitment, retention, and overall operational efficiency. The COVID-19 pandemic has highlighted the need for a more adaptable and flexible approach to conducting clinical trials, which can be achieved through the adoption of hybrid clinical trial models. In this blog post, we will explore the concept of hybrid clinical trials and discuss how their adoption of data collection can help minimize disruptions and improve the overall efficiency of clinical research.

What are Hybrid Clinical Trials?

Hybrid clinical trials, are a combination of traditional, centralized clinical trial designs and decentralized approaches that leverage digital technologies and remote monitoring tools. These trials allow participants to engage in clinical research through the use of telemedicine, remote assessments, home visits, and local healthcare providers, reducing the need for patients to travel to a central clinical site.

Hybrid clinical trials combine aspects of traditional clinical trials with virtual or remote technologies, such as telemedicine, mobile health apps, and wearable devices. Hybrid trials can offer several advantages over traditional trials.

The Need for Hybrid Clinical Trials

Conventional clinical trial designs’ main challenge is participant recruitment and retention. A large review of randomized controlled trials funded by the UK’s National Institute for Health Research (NIHR) found that only 63% of trials achieved their target sample size, with 30% of studies requiring a revision of the original recruitment target (not factoring in participant dropouts) [1].

In April 2020, there was an 80% drop in new patients entering trials in the US compared to April 2019 [1]. The obvious challenge here was due to the COVID-19 pandemic, with the immediate need to reduce person-to-person contact, especially for individuals with underlying health conditions who are likely to participate in clinical studies. This disruption could have been minimized through the adoption of decentralized clinical trial approaches.

Benefits of Hybrid Clinical Trials

1. Improved Patient Access and Engagement: By allowing patients to participate in clinical trials remotely, can significantly improve patient access to clinical trials and reduce the burden of travel, time, and cost. This can lead to a more diverse and representative patient population in clinical research, ultimately improving the generalizability of the trial results.

2. Enhanced Recruitment and Retention: By removing geographical barriers and reducing the need for in-person visits, hybrid clinical trials can potentially lead to faster recruitment rates and better participant retention. This can help trials achieve their target sample size more quickly and efficiently, ultimately shortening the overall duration of the trial.

3. Operational Efficiency: The use of digital technologies and remote assessments can streamline data collection and management, reducing the need for physical site visits and manual data entry. This can lead to cost savings and increased operational efficiency for clinical trial sponsors and research organizations.

4. Adaptability and Resilience: Hybrid clinical trials offer greater flexibility in responding to unforeseen events, such as pandemics or natural disasters. By leveraging remote monitoring and digital tools, trials can continue to operate with minimal disruptions, ensuring the ongoing safety and efficacy evaluation of investigational treatments.

The Role of Clinical Trial Technology

The use of technology in clinical trials has grown rapidly in recent years, with many organizations adopting digital tools to streamline data collection, patient recruitment, and monitoring. In the traditional model of data capture, data is collected at the site level and then consolidated for analysis. However, hybrid data capture enables sponsors to optimize data collection by combining digital and traditional methods.

Clinical trial technology can help address some of the challenges of traditional and hybrid clinical trials, including:

1. Remote monitoring: Clinical trial technology can enable remote monitoring of participants, reducing the need for physical visits and the burden on participants.
2. Real-time data collection: Clinical trial technology can facilitate real-time data collection, allowing researchers to analyse data more quickly and make more informed decisions, meeting the unique needs of their clinical trials and ensuring high-quality, accurate data.
3. Improved patient engagement: hybrid data capture can be used to ensure that patients are engaged in the data collection process, as well as to ensure patient safety and data accuracy.
4. Hybrid data capture can be used to ensure that data collected from EDC is compliant with regulatory standards such as Good Clinical Practice (GCP).
5. Reducing Costs: By combining digital and traditional methods of data collection, sponsors can reduce the need for physical visits and associated travel costs.

In summary

The adoption of hybrid clinical trial models offers significant benefits in terms of patient access, recruitment, retention, and overall operational efficiency. The COVID-19 pandemic has highlighted the need for a more adaptable and resilient approach to clinical research, and hybrid clinical trials provide a promising solution to minimize disruptions and the use of clinical trial technology can help improve the overall efficiency of clinical trials now and in the future.

[1] NIHR. (2014). “Recruitment to trials: a review of the challenges, and some solutions.” Retrieved from https://www.nihr.ac.uk/documents/recruitment-to-trials-a-review-of-the-challenges-and-some-solutions/12277

[2] Clinical Trials Arena. (2020). “COVID-19 pandemic highlights need for decentralized clinical trials.” Retrieved from https://www.clinicaltrialsarena.com/comment/covid-19-decentralized-clinical-trials/