Part Three of the Decentralized Trials Series  

So far, in our decentralized trials series, we have discussed the benefits of fully remote clinical trials and the advantages they provide to study subjects. However, not every sponsor or clinical research organization (CRO) feels comfortable with fully decentralized trials. Financial limitations, apprehension about technology, and protocol specifications are all reasons someone might choose the traditional, in-person method of clinical trials. Fortunately, hybrid options allow subjects to submit data remotely while being required to visit a clinic occasionally.

Partially decentralized trials combine remote and on-site options for subjects so that sponsors and CROs can benefit from electronic data tools while still requiring in-person contact. Patients who cannot afford remote equipment, feel uncomfortable navigating modern technology, or distrust data transmission over the internet might be more likely to opt into partially decentralized trials to match their lifestyles.  

So, what does a partially decentralized trial look like? On the site side, site personnel would have access to the electronic data capture (EDC) system via the internet – they would simply enter the study-specific URL into a browser, log in, and add or edit subject data or answer any monitor queries. The subject side has two parts – on-site visits and remote data entry via ePRO. ePRO is a mobile app that allows patients to answer survey questions, configured per protocol specifications, from a mobile device in any location – as long as they have a connection to the internet.

The on-site visit is straightforward – the subject comes to the site, and site personnel enters the subject data into the EDC based on whatever is required on the forms for that specific visit. With ePRO, the screening visit will typically include an ePRO enrollment form. Once enrolled, the subject can download and log into ePRO. Now what? It depends on the study protocol, but ePRO surveys are typically scheduled around visit dates. So, a subject would receive notifications on their mobile device around expected visit dates requesting that they complete a survey. The subject can then complete the survey remotely or with the technical assistance of a clinician at the site when they come in. All survey responses feed directly into the EDC for site and study review.

Prelude EDC also has the option to create “always available” surveys if the protocol calls for them. Subjects may access always available surveys throughout the duration of their study participation from anywhere on a mobile device. An adverse event (AE) survey is an excellent example of this type of survey – the subject experiences an adverse event, goes to the AE-related ePRO survey, enters a start date, symptoms, any medications taken, and is prompted to call in for a visit. Again, survey responses feed directly into the EDC, where site and study personnel can review the subject’s reported data and determine the next steps.

Partially decentralized trials are just one of several options for subjects and clinicians to optimize their clinical trial experience. Schedule a call to learn more about our options for your decentralized trial. 

 

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