Hybrid clinical trials include elements of both traditional and decentralised clinical trials which maximise the quality and rigor of the study results. As the ongoing COVID-19 pandemic continues to change the landscape of medical research, Sponsors have embraced the benefits of both decentralised clinical trials and aspects of traditional trials (procedures performed at sites), believing that hybrid clinical trials combine the best of both worlds.
The global rise in decentralised clinical trials has caused a common misconception that they will remove the need for physical sites and replace traditional clinical trial roles. However, despite all the ongoing technological advancements, only a small amount of clinical trials can be completely virtual. Most trials will require in-person site visits for tests and certain procedures. For this reason, hybrid clinical trials have become the optimal solution to clinical trial models.
Benefits of Hybrid Clinical Trials
The benefits of hybrid clinical trials include:
- Best of both worlds: Hybrid clinical trials are the perfect balance for people who want both personal interaction and the reassurance of seeing a physician in-person, yet also want the flexibility of being able to take part in the clinical trial from the comfort of their own home and use the latest advancements in technology.
- Increased participant engagement and retention: The relationship between a participant and a clinical trial site is important, especially when it comes to participant engagement and retention. Clinical trial sites understand a participant’s needs and can make accommodations for each participant. This makes participants feel more comfortable and engaged in the clinical trial. Hybrid clinical trials make it possible for this relationship to continue.
- More participation options: Sponsors are able to collect clinical research data both in person and virtually meaning that they can offer more participation options to patients.
- Increased interest: An increased interest in clinical trials reflects the growing recognition that decentralised and hybrid clinical trials can open up access to new patient populations, accelerate enrolment and increase retention.
- Diverse patient population: Not being bound by a physical location means that a diverse group of patients can enroll in the clinical trial without too much disruption to their daily life. Having a diverse group of participants is especially beneficial for clinical trials that are focused on rare diseases, as a diverse patient population means better results.
- Lower costs: Not having a full-time physical clinical trial site cuts the cost of clinical trials.
- Technological advancements: Continuing technological advancements like wearable devices and smartphones have made decentralised and hybrid clinical trials possible by allowing medical and lifestyle data to be collected from participants and sent to the clinical trial staff in real time, resulting in more valuable data. It also makes virtual meetings between participants and clinical trial staff much easier.
Challenges of Hybrid Clinical Trials
Some of the ongoing challenges of hybrid clinical trials include:
- Multiple clinical trial models: Offering both virtual and traditional clinical trial models may present challenges when it comes to communication, paperwork and participant care.
- Supply chain: The supply chain plays a crucial role in direct-to-patient (DTP) and direct-from-patient (DFP) services that have been integrated into decentralised and hybrid clinical trial protocols. The Sponsor, Contract Research Organisation (CRO), supply chain specialist, and other vendors need to sit down and establish a detailed distribution plan. This plan needs to include how the trial will distribute and track the medication and how it will ensure the safety of participants who are treated at home. It also needs to outline the protocols for shipping packages to participants’ homes. What happens if a participant isn’t home to receive the package? And how will participants return unused medication at the end of the trial?
- Chain of custody/care: There needs to be a detailed record of participant and clinical trial staff communication, and a clear outline of how the trial staff will coordinate with participants and nurses for any home care required.
- Different laws and regulations: The regional variation in laws and regulations is one of the main challenges facing decentralised and hybrid clinical trials. Limiting the clinical trial to one country usually eliminates many of these issues, but at the same time, it can also limit the patient population for some clinical trials.
- New technology: Clinical trial staff and participants have to adapt to learning how to use new software and technologies for a decentralised or hybrid clinical trial to run smoothly. This includes a central database system, wearables to collect data and programs which support virtual meetings.
Decentralised and hybrid clinical trials have become a growing reality, especially in the face of the COVID-19 pandemic. Sponsors, Investigators, Contract Research Organisations (CROs) and the rest of the clinical trial staff will continue to adapt to the changes in the research and medical industry. Although there are ongoing issues while adapting to decentralised and hybrid clinical trial models, the benefits far outweigh any possible challenges and more Sponsors are planning highly-effective hybrid and decentralised clinical trials. What is most important to clinical trial staff is that there are strong site relationships, open communication and an understanding of everyone’s capabilities and resources which should apply to all clinical trial models.
Most people view hybrid clinical trials as the ‘best of both worlds’ when it comes to clinical trials. As only a very small percentage of clinical trials can be fully virtual, hybrid clinical trials provide the perfect solution which is reflected in their growing popularity that will surely continue long after the COVID-19 pandemic is over.
Novotech CRO is proud to be supporting development in clinical research with its virtual and hybrid clinical trial solutions that take advantage of the many regional advantages the Asia-Pacific region provide.