Recent research revealed that the number of clinical trial executives planning to conduct hybrid trials rose to 77%. This is a 59% increase from the previous year. Before we jump into the benefits of hybrid trial design, let’s dive into the critical elements of a hybrid clinical trial.
What is a hybrid clinical trial?
Traditional trials – otherwise known as randomized controlled clinical trials – are typically the standard when evaluating the efficacy and safety of new drugs and medical devices. However, the continued development of technology has created more real-world data that is collected via electronic health records, medical claims, patient registries, and patient-generated data.
In 2016, the US Congress mandated the FDA to establish a program to “evaluate the potential use of real-world evidence for regulatory purposes.” One type of study identified in the resulting FDA framework was the hybrid clinical trial or integration of a traditional randomized controlled trial with pragmatic design aspects to collect real-world patient data.
Using a hybrid clinical trial design preserves the benefit of randomization and provides real-world outcome data while potentially accelerating product development. The hybrid approach may also lower the cost of data collection and patient follow-up.
Overall, the hybrid approach strikes a good balance between patient convenience and the benefits of in-person engagement. Clinical operations teams may find that they can retain the advantages of face-to-face interactions between investigators and patients while lowering the risk of patients choosing to discontinue participation due to cost, time commitment, or inconvenience.
How do hybrid trials differ from other types of clinical trials?
Hybrid trials are just one option available to conduct clinical trials. Different trial designs have various advantages for both trial sponsors and patients.
Traditional clinical trials
Until recently, clinical studies were only conducted in person. Patients enrolled in a traditional clinical trial must travel to a research site, which might be as close as a local clinic or physician’s office or as far as a medical center located in another state.
Limitations of traditional clinical trials include:
- Costly
- Less efficient than other types of trials
- High barriers to patient participation, including financial burden and schedule requirements
- More risk to recruitment, enrollment, and discontinuation of participation
- Lack of diversity among trial participants, depending on location, financial resources, or other forms of support
Virtual or decentralized clinical trials
Within the last decade, virtual clinical trials or decentralized clinical trials grew in popularity due to the availability and maturity of new technology. These trials are conducted virtually using smartphones and tablets, apps, remote monitoring devices, or wearable technology, or even via online patient engagement platforms.
The primary benefits of decentralized clinical trials include:
- Overall reduction in barriers to participation
- Increased convenience
- Less risk of discontinuation
- More accurate data due to technology
- More patient-centered protocols
However, the impact of digital clinical trials or decentralized trials can include drawbacks, such as:
- Information security concerns
- Technical difficulty with devices, apps, or human abilities
- Less personal interaction and perhaps less engagement
What are the challenges of hybrid clinical trials?
The COVID-19 pandemic put the brakes on many trial activities in 2020. While the impact of this slowdown should not be overlooked, the crisis did accelerate the adoption of hybrid and virtual trials, even though many trial sponsors were forced to learn on the job. This learning curve seems to represent one of the most significant drawbacks of conducting hybrid clinical trials.
A survey of trial executives revealed varied experiences with hybrid or virtual trial approaches, with almost half saying the task was challenging. However, nearly the same number said the incident was reasonably successful or adequate. Few trial executives had extreme experiences of any kind – less than two percent rated their experiences as “seamless” or a “disaster.”
Other challenges in using hybrid trials include:
- Regulatory concerns
- Site integration
- Data security concerns
- Training
- Internal buy-in and change management
- Initial cost
“While many of these experiences will have played out ‘on the fly’ during the pandemic, there is clearly a learning curve in this process, and often a cultural shift.” – Science 37
What are the benefits of hybrid clinical trials?
As discussed, hybrid clinical trials stand to benefit trial sponsors, investigators, and clinical trial participants. In designing a study protocol, trial teams may discern that a specific type of trial offers more benefits than an alternative approach. Understanding the key benefits is an important factor in making that decision. The primary benefits of hybrid clinical trials include:
Improved patient experience
Signing up for a clinical trial is voluntary, but for many patients, convenience is a significant factor in compliance and continued participation. This might mean the ability to not travel to a trial site or to travel only occasionally or when convenient. It also might mean having the ability to communicate directly with investigators – either to ask questions or to share personal experiences. Patients also want to feel that their time and participation are meaningful. Providing them with information and support can make the difference between a poor experience and a more positive experience.
Increased patient retention
Patient retention is crucial to trial success. Good retention rates help keep a study on schedule and save trial sponsors time and money. Any delay during a clinical study can harm the study process. One way to lower dropout rates in a clinical trial is to focus on patient needs – not just the information they need to follow participation guidelines, but providing opportunities for patients to be heard. Companies that take more patient-centric approaches to trial design and execution reduce average enrollment time and shorten the timeline from the first patient dose to the product launch.
Faster recruitment
The success or failure of a clinical trial depends on many factors, but one of the most critical is patient recruitment. According to research, an incredible 85% of clinical trials fail to meet their recruitment goals – putting study data quality and development timelines at risk. Inefficient trial recruitment efforts can add almost 11 months of delays for late-stage trials, driving up operational costs and delaying time to market.
In hybrid trials, teams can use asynchronous engagement technology to train and onboard trial sites concurrently, helping to ensure all sites and investigators are well-trained and properly engaged. This can speed recruitment and potentially affect overall trial success.
Preserving in-person interaction
Patient-focused drug development is a new watchword for life science organizations. The US FDA offers guidelines around the concept, encouraging trial sponsors to integrate patient input from the earliest possible stages of a study. Some of the most critical aspects of patient centricity are opportunities for in-person interaction, where patients may feel an increased sense of being cared for and heard. One of the primary challenges in decentralized healthcare is keeping patients engaged – hybrid clinical trials allow trial sponsors to offer patients a personalized experience.
Technology’s role in hybrid trials
Hybrid clinical trials wouldn’t be possible without widely available and accessible technology, including smartphones, tablets, smartwatches, other wearables, and computers. As more patients access these devices, participant pools will become larger and more diverse. Many patients may simply prefer using devices to visit sites in person, and hybrid trials are an excellent benefit to those who like to have options.
Purpose-built technology, including insights management platforms, gives trial teams the flexibility to not only develop trial protocols and engage investigators using asynchronous engagement but also provide the ability to engage patients, establish online communities or resource centers, and use tools like social listening or natural language processing to identify trending topics and determine the sentiment of patient input.
To understand how insights management technology supports patient-focused drug development, read about how life science teams can respond to PFDD guidelines.
Sources
National Library of Medicine. Virtual Clinical Trials: Challenges and Opportunities: Proceedings of a Workshop. https://www.ncbi.nlm.nih.gov/books/NBK548981/
Science Direct. Hybrid clinical trials to generate real-world evidence: design considerations from a sponsor’s perspective. https://www.sciencedirect.com/science/article/pii/S1551714419305713
Centerwatch. Hybrid trials may overtake traditional studies in 2022. https://www.centerwatch.com/articles/25878-hybrid-trials-may-overtake-traditional-studies-in-2022-new-data-show
Biopharma Dive. Decentralized clinical trials – are we ready to make the leap? https://www.biopharmadive.com/spons/decentralized-clinical-trials-are-we-ready-to-make-the-leap/546591/
