Virtual Clinical Trials and how they can help your research study
Although many clinical trials have halted as a result of COVID-19, there are still a number of clinical studies that are ongoing. These clinical trials have managed to continue to gather data while preserving a positive patient experience by relying on technology, remote, and mobile solutions, to reduce in-person site visits. These types of trials are called virtual clinical trials (VCTs). VCTs are not a new concept. Pfizer’s REMOTE trial in 2011, was the first randomized clinical trial that was conducted virtually to study Tolterodine on the effects of overactive bladder. Over the last decade, the adoption of VCTs has been slow, however recent clinical trials indicate that VCTs can truly break the boundaries of the traditional clinical trial model. The Apple Heart study in partnership with Stanford Medicine enrolled more than 419,000 participants across 50 states, and the Heartline Study by J&J in collaboration with Apple enrolled 150,000 participants in their nationwide heart health research study.
Fully Virtual Clinical Trials
Fully VCTs can also be referred to as Decentralized Clinical Trials (DCT). As defined by Clinical Trials Transformation Initiative (CTTI), “DCTs are defined as those executed through telemedicine and mobile/local healthcare providers (HCPs), using procedures that vary from the traditional clinical trial model”. Fully VCTs take the traditional clinical trial model that is 100% site-dependent and shifts it to an entirely virtual experience for the participants. The patients manage the entire clinical trial experience from their home through the use of various technology platforms completely independent of a clinical trial site. The fully VCT patient experience includes:
Patient check-ins are done virtually
Tests conducted remotely at the patient’s home, through in-home nursing or community laboratories
Drug/device delivery directly to the patient
Telemedicine check-ins with the consulting physicians
Data collection via virtual modalities through mobile healthcare apps
Hybrid Clinical Trials
Hybrid Clinical Trials are a combination of traditional clinical trials and fully VCTs. These types of trials have evolved as sites have combined elements of each model to ensure an optimal patient experience while reducing patient burden and site visits. Hybrid clinical trials maintain some activities at the traditional clinical trial sites and manage other activities via the use of technology platforms which yields a limited amount of in-person visits. This may involve a combination of one or more VCT components mentioned above, which includes patient check-ins done virtually, tests conducted remotely at the patient’s home, through in-home nursing or community laboratories, drug/device delivery directly to the patient, telemedicine check-ins with the consulting physicians, data collection via virtual modalities through mobile healthcare apps. This utilization of different experiences for the patient, personalizing the experience and bringing it to a patient’s home is thought to alleviate the patient burden by reducing the number and/or the length of the site visits.
VCTs have also shown incredible resilience during the COVID-19 pandemic. Some have managed to continue, and others have even launched despite the major hurdles posed by the pandemic. The CHIEF-HF study by J&J, is a randomized, double-blind, placebo-controlled virtual trial that successfully launched in March 2020.
What to consider when implementing Virtual Clinical Trials
A recent white paper published by PRA Health Scienceshighlights has underlined the key considerations in operationalizing VCTs:
The type of data that must be collected.
Patients willingness to move the clinical trial experience to their homes.
Vendor partnerships as wearables and devices are continuing to innovate.
Supply chain considerations to allow device/drug delivery directly to the patient.
Patient support services which include call centers.
Continued regulatory support.
Reliance on mobile healthcare providers which includes in-home nursing services.
In addition to these considerations, the technology platform used and having access to pre-screened participants are of critical importance to the success of launching a VCT.
Citruslabs' bread and butter is technology. We use technology to recruit patients for your clinical trials and match them to your criteria - also for virtual clinical trials. Through our health app network, we are able to educate our users about clinical trials and allow them to sign up to get matched with the right trial. Citruslabs has been working on over 200 different clinical trials to date with large sponsors, leading CROs and sites.
Need help with recruiting for your (virtual) clinical trial? Get in touch with us today!