Hybrid clinical trials combine the advantages of traditional clinical trials with those of a more modern, decentralized trial model. Sponsors are taking note of the remarkable flexibility that this trial approach offers. As seen on veristat.com, using Veristat hybrid clinical trials has the benefits of randomization and real-world data, and it could also speed up the development of new products. The hybrid model can also reduce the cost of patient follow-up and data collection. Sponsors of clinical trials and CROs that develop hybrid clinical trial protocols can choose from a wide range of decentralized technologies. They must determine whether traditional site visits are still required for complex operations or specialized assessments, and where patients will benefit from virtual processes. So, how can you tell if your trial is a hybrid?
What Makes a Hybrid Clinical Trial?
Trial model design
Hybrid clinical trials combine in-person and remote study activities using wearables, mobile phones, or other technologies. Veristat hybrid designs let sponsors combine parts of both traditional and remote models to suit the needs and objectives of the study. Hybrid clinical trials are done in many different therapeutic areas, but they are especially useful for studies with hard-to-recruit patient groups or patients who have trouble making regular site visits. Therefore, patients can do clinic-based study tasks at home. When in-person medical supervision is needed, patients and their sponsors can be better served by combining in-person visits with remote monitoring.
Hybrid trials leverage both traditional and decentralized tech
Hybrid trials are decentralized, so the sponsor or clinical research organization (CRO) must have access to a wide range of digital tools and platforms to make sure the trial is managed well. Hybrid trials combine conventional in-clinic procedures with newer, more convenient methods of data collection and informed consent. Hybrid trial designs use technology to reduce common patient concerns and speed up site operations. This helps sponsors meet patient needs better and get more meaningful results. Clinical trials that use virtual study components have proven to have increased patient recruitment, compliance, improved patient monitoring, retention, and the patient’s overall experience. Through direct-to-patient IP shipment, remote screening, and telehealth visits, hybrid trials increase access to a bigger, more diverse group of patients while easing the strain on investigators.
Hybrid trials give sponsors more options for achieving their study goals. With a modular study design method, sponsors can choose whether DCT or traditional components are best for keeping accurate records of results, whether they are done online or on-site. This, in turn, improves the delivery of accurate endpoints. Sponsors can combine remote trial outcome capture using digital instruments (ePerfO), on-site trial outcome capture (ClinRO, eClinRO), or both, depending on the specifics of the study and the endpoints that need to be met.
The growth of technology and digital platforms like wearable devices, sensors, and cloud computing has led to the rise of hybrid trials. Taking advantage of the benefits of hybrid trials can help sponsors save money, boost patient involvement, and collect data that is more typical of real-world conditions.