In this blog post, we will try to understand Virtual Clinical Trial. As technology continues to become better and more integrated into the clinical development industry we are seeing increasing interest in trials that don’t require sites. Instead, many sponsors are beginning to plan trials where all patient data is gathered electronically directly by the patient. So what if participating in a clinical trial didn’t require traveling to a site? What if reporting general health condition, adverse events, and trial outcome data could be done through devices (maybe a phone, watch, or laptop). It’s not the future – it’s happening right now.
The drive towards virtual trials is being led by two converging forces. On one side, the cost of taking a new treatment has been ballooning. We won’t be going into all of the reasons for this growth here, but it’s sufficient to say that as we trend towards more complex protocols and treatments, we also trend towards higher costs. On the other, the pharmaceutical industry is making a much-needed shift towards greater patient-centricity. Instead of developing and evaluating new treatments in a vacuum, life science companies are beginning to focus on the importance of the patients in the design and evaluation of these treatments.
These two forces are combining to push the boundaries of what a clinical trial is and can be. One of the new solutions is the virtual trial, and it carries with it many advantages over a traditional trial with sites:
Advantages of virtual clinical trials include:
Less Burden On Patients: Travelling to sites can be stressful, expensive, and exclusionary. Eliminating the need to go to sites minimizes the burden of participating in a clinical trial for patients.
More Robust Data Collection: Tracking technology has evolved and allows life sciences companies to collet an incredible amount of data remotely through devices – more than can be collected in a series of office visits.
More Robust Safety: With 360 degree tracking and data collection, sponsors and CROs can immediately know when a patient is at risk, and can respond appropriately.
Access to More Patients…: A lot of patients are excluded from site-based trials for many reasons: they live too far from sites, they don’t have regular transportation, they have a disability that makes travel difficult. Virtual trials make it easier for them to participate, and opens a larger pool of participants.
… And Better Patients…: The plethora of data available remotely allows for remote screening, making the screening process faster and allowing for better participant selection
… That Enroll Faster: The ease of screening, and the ability to take your recruitment message directly to patients over mass media (social media, for example) gives sponsors the ability to fill trials much faster than with conventional trials
Better Retention: Patients tend to stay in trials longer when they have a lower burden to participation. Removing most site visits actually makes it much more likely that patients don’t drop out
This is a quick overview, and far from a definitive list of benefits. However, even from this cursory look, it’s obvious that virtual trials offer tremendous benefits to both sponsors and patients. We will be taking deeper dives into some of these reasons in later posts, and talking about virtual trials quite a lot over this year. We will also be exploring how virtual trials and other emerging technologies intersect with our centers of excellence.