Hybrid Clinical Trials Marks the Shift to Decentralization, Says ObvioHealth
Leading Virtual Research Organization (VRO), ObvioHealth, has stated that hybrid clinical trials are rising and will only get more popular in the coming years.
To emphasize this point, the CRO pointed out that hybrid trials exceeded traditional on-site trials in 2021 at 59% and 77% in 2022.
This comes a mere two years after the FDA recommended that sponsors incorporate DCT elements into their clinical study designs wherever appropriate in 2020.
This trend is being applauded by sponsors and participants alike because the model improves the quality of research and helps bring about better healthcare innovation, claims the company.
The VRO asserts that there are several ways in which DCT elements in hybrid trials can deliver better results. However, the company focused on the three most important ones, which are driving operational efficiency, increasing participant engagement, and enhancing data quality for more robust evidence.
According to the company, hybrid clinical trials came into existence in 2011 when Pfizer announced that it would conduct a trial without using any physical sites. This sparked a reconceptualization of how clinical trials should be carried out.
ObvioHealth goes on to explain that DCTs exist on a spectrum where one end is the traditional form of trials while, on the other end, are fully-virtual trials. Hybrid clinical trials fall in the middle of this spectrum, with some being more site-centric than others.
Whilst the phases and functions of the trial remain the same, hybrid ones may use technology to undertake certain aspects, explains the company.
The company also discusses the practical application of clinical trials, stating that they can be used for therapeutic areas of study, desired endpoints, and industry sectors.
In therapeutic areas, hybrid trials offer participants the opportunity of completing certain study tasks from the comfort of their homes. That can be particularly useful for the study of infectious diseases, according to the VRO.
Similarly, hybrid trials provide sponsors with greater flexibility to achieve their study endpoints. It can be especially useful in mitigating the “white coat effect”. That refers to the phenomenon where the readings of vital signs such as blood pressure could be affected by being in the presence of a medical professional.
Even industry sectors are benefiting from the hybrid model, asserts the company.
According to the VRO, hybrid clinical trials can be beneficial for three key reasons: improved operational efficiency, higher patient engagement, and enhanced data quality.
However, while there are benefits, ObvioHealth explains that hybrid clinical trials also face certain challenges.
Even though the FDA wants to promote DCT methods, there might be regulatory concerns in countries outside the U.S. where adoption rates are lower.
There is also the concern that complex hybrid trials might run the risk of operational, logistical, and communication problems if not coordinated properly.
Since hybrid trials rely on technology, they must ensure that the tech used is reliable, accessible, and allow systems integration.
Hybrid trials should also ensure that patients know who to reach out to in case of confusion and that all communication be closely synchronized.
However, according to the company, all four of these challenges can be mitigated by partnering with a VRO with the right experience. All in all, according to the company, the benefits of hybrid clinical trials far outweigh the challenges.
ObvioHealth has been leading the digitalization and virtualization of clinical trials through its platform and app to accelerate the development of drugs and devices around the world. To learn more about what the company offers, please visit https://www.obviohealth.com/
ObvioHealth USA, Inc.
545 West 25th Street
Disclaimer: The views, suggestions, and opinions expressed here are the sole responsibility of the experts. No Florida Times Daily journalist was involved in the writing and production of this article.