The Debate and Discussion Over Decentralized Clinical Trials

COVID-19 has led to debates on virtually every component of healthcare; the topic of how best to conduct clinical trials included.  The new discussion centers around the pros and cons of centralized vs. decentralized clinical trials in wound care. 

At their core, a centralized trial is one where there is a central location, with centrally located trial administrators, for patients to visit to report key data and check the status of a wound. In a decentralized trial, there is no set location and digital tools are the predominant method used to track and report on the status of a wound.

Centralized, or traditional trials, are predicated on two challenges:  1) recruitment and 2) patient access. With recruitment, because centralized trials are only run in a determined number of sites, the number of patients that can participate is limited based on their ability to access the trial site. Additionally, because patients have to travel to the trial site, they may lose the incentive to participate based on factors ranging from transportation to overall fatigue in the process.  

A look at the decentralized trial process

Enter the decentralized clinical trial. While a new concept, the process provides several promising features, especially considering the challenges of centralized trials and the ongoing reality of the pandemic.  Here are the steps that take place in a decentralized clinical trial.

• The trial administrator connects with clinicians online who can help with recruitment and bring awareness to patients that there are trials that could benefit their conditions. 
• The “virtual” screening is simplified by submitting required screening data through an electronic platform. So, for example, a rural clinician can now assist or help with submitting patients’ data to the trial sponsor so it can be screened “virtually.”  For a study sponsor, this step helps with recruitment beyond the traditional network of sites.
• Once participants are identified, they can be given access to a digital tool (as in a smart phone app) so they can report data remotely from their home, or any other setting where they are located. 
• The same app can also be leveraged for patient engagement and compliance.  For example, patients could be reminded to submit data with notifications.  They can also request calls or teleconferences through the app to discuss questions or concerns, which ultimately helps to keep the patient on track and engaged.
• Occasional site visits to check status.  Are site visits fully eliminated in a decentralized trial?  No, because in wound care, clinicians need to physically assess patients periodically.  However, the process does streamline the reporting process by enabling some visits to be handled remotely.  And, when in-person visits are necessary, data can be submitted online making the visit shorter and more efficient for all.

Ending the debate

To launch a decentralized clinical trial, sponsors and wound care manufacturers must first embrace digital tools and apps first, welcoming these technologies in a “hybrid” manner. While such direction may seem standard for healthcare, the wound care market is behind the technology curve as most trials still use paper forms and traditional provider recruitment methods.

Digital tools are what enable the factors necessary for a decentralized clinical trial, from identification of providers and participants to the actual review of the wound, to compiling, analyzing and reporting on data. 

With the value becoming increasingly clear, the debate on decentralized clinical trials will soon end and the focus will turn to how to expand and further refine the approach so that all participants can benefit from new treatments.

Tissue Analytics is one of the pioneers in the use of digital technologies and virtual clinical trials. To find out more, contact Nico O’Kuinghttons at nico.okuinghttons@nethealth.com