Sponsors and CROs are preparing to conduct more hybrid clinical trials than traditional site-based trials, marking a turning point for the industry. A poll found that 77 percent of clinical trial executives planned to perform hybrid trials next year, up from 59 percent the year before.
Hybrid clinical trial models have their roots in decentralized clinical trials (DCT), which use a combination of virtual and in-clinic workflows to complete the necessary trial procedures. Due to technology and virtual techniques, nearly all clinical trials today are at least partially dispersed.
Why are there such a large number of novel clinical trial designs?
Digital or virtual clinical trials have replaced many conventional in-person activities in clinical trials. It is puzzling why the industry is using so many different terms to convey what appears to be one central concept.
But two factors are at work.
- The quest toward virtual, hybrid, decentralized, and site-less clinical trials is motivated by several issues that afflict clinical research, including the following.
- Reaching patient populations who don’t live close to current study facilities can be challenging.
- Increase in the price of performing clinical research (much of it in site costs)
- The availability of new technology.
- The second is that COVID-19 nearly put an end to the majority of in-person activities in 2020. As a result, we continued to innovate. We haven’t had the maturity or time to settle on one concept because the industry has grown swiftly.
Virtual, decentralised and hybrid clinical trials refer to three different ideas. Despite being distinct, they all highlight the necessity for clinical operations directors to discover novel approaches to training study participants and caregivers at scale to prepare them for their new virtual roles.
How do hybrid clinical trials work?
A virtual design might be perfect for you if your future clinical trial is straightforward and doesn’t call for any in-person meetings.
You should seriously explore a decentralized trial design if your study calls for several patient demographics and you have the resources to train various healthcare professionals to deliver your investigational product.
What happens if you see a chance for your experiment and need some decentralized sites and at least one appointment inside the clinic due to procedures or tests? At the moment, this is the likely outcome of upcoming trials. The term “hybrid clinical studies” describes them. Hybrid clinical trial designs of today are one of the driving forces for technological adoption. Which is
- Greater confidence in its dependability is made possible by wearable technology designed for consumers and validated through trial sites.
- What establishes that on-demand learning will be effective for educating trial teams at scale is the delivery of CRA content on learning platforms by significant CROs like PRA.
- Traveling phlebotomists and home nurses are setting a precedent by using mobile technologies to reach underserved areas quickly.
Even the FDA seems to be interested in the advantages of a hybrid trial design. As early as 2018, the organization used the study design within its RWE framework. And following the COVID-19 outbreak in the US, it released new advice reaffirming its willingness to adopt innovative technologies.
Decentralized, virtual, or hybrid?
What phrase should we use then? All of them. Each trial type has unique advantages for currently planned clinical trials. Clinical research is not always ready for complete decentralization and remote monitoring. Many trials contain subtleties that make them too complex to follow the protocol without human supervision.
Despite its growth, telemedicine still doesn’t inspire all patients the same as a face-to-face encounter, at least not yet. Additionally, it is not better for all trials due to responses, adverse events, or the sophisticated monitoring equipment required. Only the hybrid clinical trial model presents an appropriately flexible scenario that helps any amount of technological enablement for many clinical studies starting today. You can mix and match centralized and decentralized tools and processes based on your particular study objectives and protocol.
Utilize the resources at your disposal right now while you develop the talent to embrace a virtual future. No matter how virtual or decentralized your hybrid clinical trial may be, many can provide you with immediate value.
Effects of the pandemic on the adoption of Hybrid Trials
Researchers who conducted clinical trials claim that this adoption is due to three factors.
- Consumers are becoming more comfortable with technology and using wearables and telehealth in many aspects of their daily lives. As a result of the increased use of remote health technologies during the epidemic, patient comfort with remote interactions increased by three times.
- Focus on the Patient Experience: During the pandemic, there were challenges with patient retention and recruitment. DCT makes it possible to include patient-centered trial features like telehealth, direct-to-patient trial supplies, and remote monitoring that have lower costs while boosting recruiting and retention efforts.
- Tool Maturity: Although DCT technologies have existed for a long time, they are now receiving more validation and direction from regulating organizations. Due to regulatory regulations and evolving tools, trial operators feel more comfortable digitizing and decentralizing their studies as digital endpoints replace traditional endpoints as the principal endpoint.
Using a hybrid clinical trial design: A strategy
The objective of a hybrid study is the same as that of every clinical trial: to demonstrate the efficacy and safety of a novel therapy compared to an accepted control.
The sponsor of a hybrid trial must keep the following things in mind
- Patient’s needs
- Determining whether digital tools would be helpful for use in a trial and which technologies would be appropriate requires understanding the patient group. It is necessary to consider the patient’s age, mobility, health, and technological comfort level, among other things. Although elderly patients may experience anxiety when using these tools, simple DHT tools for them rather than younger ones can reduce the stress of on-site visits for elderly patients. Every trial needs consent, so it’s crucial to use the digital consenting procedure while considering the patient demographics and the level of detail required to make patients feel at ease and keep them interested in the study.
- Characteristics of an investigational product (IP)
- Determining whether to allow for drug administration by
- a nurse or technician in neighbourhood clinics, at home by a technician or nurse (decentralized approach), or at a trial site by skilled professionals who can closely monitor the patient for any adverse reactions depending on the safety profile and knowledge about the IP.
- Study design and endpoints
- Using digital health technology (DHT) to collect patient data for trial endpoints may be chosen, depending on the complexity of the trial. We can use wearables, electronic patient-reported outcomes (ePRO), and telemedicine methods that do not require expert assessments.
- Digital Health Technology (DHT)
- In the submission, it must be clear (fit-for-purpose) what kind of DHT (sensors, software, or a combination of both) will be used in the study and why.
- Regulatory aspects
- The sponsor of hybrid or decentralized trials must be well-versed in local and regional regulations on DHT and virtual methods for securing patient consent and conducting trial evaluations. Submissions must also contain information on DHT validation and verification investigations, which the manufacturer can supply.
Hybrid clinical trials using virtual tools
Due to the decentralized nature of hybrid trials, the sponsor or contract research organization (CRO) must have access to a wide range of digital tools and platforms to manage the clinical trial effectively. It is crucial to consider some factors that differ significantly between in-clinic and decentralized clinical trials, such as
The expansion of local sites or patient education initiatives.
There are challenges with data security and disseminating information.
- Patient Participation
- Electronic signatures (eSigns) and electronic consent (eConsent) for patients (DocuSign).
- Patient recruitment via social media, virtual pre-screening, and marketing channels
- Patient support and education: telephone helplines, video-recorded training sessions, and patient portals
- Patient compliance: email and SMS reminders.
- Training for Site Management Staff
- Recorded online courses and video presentations
- Remote monitoring includes electronic data capture (EDC) platforms, clinical trial management systems (CTMS), workflows, documents, milestones, clinical trial site activities, and data analytics.
- Risk management: Using spreadsheets as virtual risk management tools
- Electronic trial master file documentation (eTMF).
- Supply of trial
- Shipments are made directly to patients or locations.
- Assignments for investigational products (IP) and kits are recorded using interactive response technology (IRT).
- Tracking software and GPS
- Software for recording temperature and humidity.
- Evaluations and Monitoring.
- Applications for smartphones and tablets and telemedicine platforms
- Electronic case report forms.
- both electronic patient-reported outcomes (ePRO) and outcome assessment (eCOA) (CRF).
- The pandemic stressed the value of decentralization and the requirement that clinical trials embrace more flexible virtual methods. By making clinical research more available, practical, and customizable, hybrid clinical trials are bringing about a new paradigm shift that is patient-and site-centric.
- However, as hybrid and virtual studies gain popularity, organizing and keeping data has become challenging. Sponsors and CROs should work with vendors who uphold data security and quality.
- All wearables, ePRO tools, and apps must operate on approved technology to deliver accurate results. Decentralization and hybrid trials do not have a universally applicable strategy. Before deciding on the level of virtualization to adopt, we should carefully consider each study. Hybrid trials, however, are undoubtedly a driving force behind the modernization of clinical research, and they don’t show any signs of slowing down anytime soon.
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