Hybrid Clinical Trials
Up to 50% of trials cannot be completed due to a lack of enrolled patients and additional sites need to be opened for $50,000 each to make up for the patient recruitment shortfall.
Hybrid clinical trials combine the known quantity of site-based trial protocols with the introduction of real-world evidence (RWE) and digital biomarkers plus access to a broader patient population. This enables more frequent data points to be captured to expedite the trial process and more diverse patient populations to be recruited regardless of their proximity to trial sites.
Aparito’s digital health technology platform helps stakeholders adopt hybrid clinical trials and enables patients to engage with studies on-site and via a user-friendly interface using iOS and Android devices.
Hybrid Clinical Trials and RWE
Hybrid clinical trials can be defined as using Real-world Evidence (RWE) in the collection of data for safety and efficacy in clinical trials. RWE relates to patients’ health information obtained from routinely collected real-world data (RWD) using sources other than traditional clinical trials.
Although Randomised Clinical Trials (RCTs) are still considered as the gold standard for conducting trials and submitting data for marketing authorisation applications in the regulatory decision-making process, it is now commonly agreed that hybrid clinical trials and the benefit that real-world evidence (RWE) can bring added value.
Until recently, RWE was mostly used for safety and efficacy data for already approved medicinal products and in particular to monitor safety signals in pharmacovigilance or the Risk- Management plan.
A survey conducted by the European Medicines Agency (EMA) on new marketing authorisation applications (MAAs) or extension of indications (EOIs) submitted in 2018-2019 (EMA survey) showed that a large number of applications used RWD either for efficacy or safety studies. Registries or hospital data were the most frequent source of information. Using RWE would be particularly relevant for rare conditions or advanced therapy medicinal products (ATMPs) such as gene therapy where traditional RCTs might not be possible from a feasibility (e.g small subpopulation) or ethical point of view (RWE and RCTs).
Following the framework published by the US Food Drug and Administration (FDA) (US RWE) in 2018, the European Regulatory authorities (EU RWE) are currently working on how to formally establish and enable the use of RWE by 2025 (Vision 2025) across the spectrum of regulatory decisions.
Aparito and Hybrid Clinical Trials
Aparito’s digital health technology application Atom5™ helps stakeholders design hybrid clinical trials and gain the benefits of site-based COA with RWE and digital biomarkers whilst recruiting patients remotely to increase the number of trial participants with data harmonisation between site data and remote data, all captured and analysed securely in our regulatory-compliant Atom5TM clinical trial platform.