When managing a clinical trial in the traditional “brick and mortar” setting, total cost can grow exponentially when accounting for the various components integral to study success. Contemplate the costs associated with the following: securing the physical site location(s), site recruitment and monitoring, employing staff (physicians, nurses, etc.), data collection and analysis, and completion of clinical procedures.
Now consider life’s most precious commodity: time. In the traditional trial setting, transportation to-and-from the study site, follow-ups with the study team, time-off from work, etc., all place an untold burden on the patient. Same can be said for the study team, who are tasked with precise data collection during each patient visit. There’s a certain amount of inconvenience placed on the patient and study team.
Bearing these resource requirements in mind, it can be suggested that some clinical trials are prone to failure at multiple levels unless run via a completely site-less (virtual) design.
ObvioHealth, a digital CRO, recently completed a double-blind randomized placebo-controlled four-arm clinical trial solely using a virtual site model (no physical site visits) which would have likely proved futile in the traditional study format, of which requires multiple site visits. This article will further analyze the rationale behind this claim.
Collection of Robust Data Points
The study in question aimed to identify gastrointestinal (GI) responses to the consumption of a dietary supplement containing inulin, while also gauging the likelihood of the participant to purchase the supplement going forward. Successful execution of the protocol required enrollment of 400 healthy U.S. adults (male/female) across four treatment groups within a ~6-week time-frame. Participants were instructed to consume the study product for a duration of 10 consecutive days and fill-out precisely timed questionnaires to report GI responses. In addition, they were required to detail changes to their health and medication/supplements.
To symbolize the challenge of completing a clinical trial with such a large enrollment target, it’s worth mentioning that the Sponsor had previously spent millions of dollars on a similar clinical trial, which failed in the traditional setting. Picture, as a participant, being asked to visit the site location multiple times over a 10-day period. Not only is the patient taking the time to commute to-and-from the site location, time is required of the doctor/staff to administer pertinent questionnaires, and to collect any health/medication related information. In the traditional setting, the participant’s ease of accessibility to interact with the study team is limited; poor engagement can result in study dropouts.
With ClaimIt, ObvioHealth’s proprietary solution for conducting studies digitally, multiple precisely-timed questionnaires were distributed to the patient, daily, via a smart phone. With no need to leave home, participants were able to provide their real-time GI response and health-related data digitally and in a precisely-timed manner, without the added hassle. Having the ability to respond to the questionnaires and report product consumption in real-time significantly reduces the chances of recall bias. Overall, more data points are collected in the virtual setting than the traditional setting; patients are not limited to providing responses only during periodic site visits.
Traditional Recruitment Restrictions
Let’s discuss the constraints of recruitment in the traditional trial setting: studies are often limited to recruiting patients referred by a healthcare professional (HCP). Thus, the study team is confined to a study population living within a reasonable distance of the study site; data points will prove to be concentrated around such locations, lacking in diversity.
Traditional recruitment is time-consuming (relying on HCP referrals) and costly when the process takes too long or involves multiple physical sites. For every day that a trial extends beyond its enrollment deadline, there is a lost opportunity cost to the Sponsor of $600,000 to $8 million. In addition, study components such as patient recruitment, site retention, and staff employment will all increase in cost as the enrollment deadline is extended. In an age where 90 % of clinical trials fail to meet the enrollment deadline, pivotal clinical trials average $19 million in cost, and trials requiring <100 patients average $6 million in cost, poor-recruitment can lead to millions of dollars lost.
When pairing social media recruitment with a virtual site setting, enrollment can include participants (in this case) living throughout the U.S., producing a diversity of data points (see map).
Patient Enrollment Count Per US State;
Enrollment goal met within 24 days of Go-Live.
Going Virtual: When Does it Make Sense?
Saving time and money by “going virtual” seems like a no-brainer, but the ability to do so revolves around protocol requirements. Should protocol require numerous physical assessments and very close monitoring of the patient, going “completely virtual” is not ideal, although a hybrid-design can be considered. However, should the study’s endpoints be attainable through the distribution of precisely timed questionnaires, and/or if the protocol aims to analyze changes in health/symptoms in a minimal-to-moderate risk setting, employing a virtual (site-less) trial design can be the formula for success.