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 technological, remote and mobile solutions to reduce in-person site visits. These types of studies are called virtual clinical trials (VCTs).
VCTs are not a new concept: Pfizer’s REMOTE trial in 2011 was the first randomized clinical trial conducted virtually to study Tolterodine on the effects of an overactive bladder. Over the last decade, the adoption of VCTs has been slow, however recent clinical research indicates that VCTs can truly break the boundaries of traditional clinical protocol and patient recruitment models. 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, also referred to as Decentralized Clinical Trials (DCT), 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 protocol that is 100% site-dependent and shifts it to an entirely virtual experience for the participants. The patients manage the entire clinical research experience from their home through the use of various technology platforms completely independent of the clinical trial site. The fully VCT patient experience includes:
Patient check-ins that 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 studies
Hybrid clinical studies are a combination of traditional clinical trials and VCTs. These types of trials have evolved as research sites have combined elements of each model to ensure an optimal patient experience while reducing patient burden and site visits. Hybrid clinical studies maintain some activities on the clinical trial site and manage other activities via technological platforms which yields a limited amount of in-person visits. This utilization of different experiences for the patient, by 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 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. For instance, 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 VCTs
A recent white paper published by PRA Health Sciences 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 technological platform used and access to pre-screened participants are of critical importance to the success of launching a VCT.
Here at Citruslabs, we've created the ideal patient recruitment dashboard to help any researcher improve their current metrics. With over 3 million patients on record, we ensure research sites are connected to a thoroughly educated and engaged pool of participants; so, it is no wonder why we have such high patient confidence! Now, we would say that other models are available - but this would be a lie. In fact, unlike that offered by other patient recruitment companies, our easy-to-use dashboard is the first-of-its-kind for the market; giving researchers a unique insight into their patients’ wants and needs via industry-leading technology. The future of clinical recruitment starts here.
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