Supporting Patient-centric and De-Centralized Clinical Trials

By Noah Cotes, Project Manager at Veracity Logic, LLC

 

Patient-centric clinical trials, also referred to as de-centralized clinical trials are often discussed in the pharmaceutical industry today.

To be “Patient-centric” is to reevaluate the needs and realities of the patient experience, and to allow that understanding to inform your clinical trial all the way from study design through the final visit. The idea itself is simple — to proceed in a manner that is informed from the outset by what works and doesn’t work best for the patient.

The goal is to reduce dropout rates, increase feasibility, and enhance patient satisfaction. By essentially shifting “power” to the patient, the potential for successful execution of a clinical trial is dramatically increased. This shift in focus can also benefit by increasing patient compliance, and decreasing the dropout rate, lowering the cost, and improving the quality of study results.

 

De-Centralized clinical trials have become much more popular and feasible in the past few years as new technology is being implemented in more clinical trials. The idea stems from patient-centric clinical trials but takes it one step further:

  • Visits can be done remotely via video chats or phone calls instead of in-office visits
  • Drugs can be sent directly to patients
  • Patients that are further away from clinical sites (which are generally located in Urban locations) can participate in studies

By making visits more convenient for the patient,this method decreases dropout rates, allows for a more diverse patient base, and lowers cost.

To assist in these de-centralized clinical trials, Veracity Logic has implemented tools and functions in our VLIRT® system. Below are three quick examples of how Veracity Logic can support your de-centralized clinical trial:

1) Just-In-Time Shipments

Just-In-Time Shipments is a setting in our system that can be enabled. It can be specified for certain activities and essentially creates a shipment request at the time an activity is recorded. The shipment contains only the kits that were assigned at the activity. The shipment can then be sent to the clinical site or directly to the subject.

2) Remote Depot with Activity Functions

This feature allows a specialized depot that might be handling the dispensation and shipment of kits directly to subjects. Subjects can have the option to “enroll” in this function or it can be controlled at the site/country level. The specialized depot has access to record activities for subjects that are participating in the de-centralized trial. Once an activity is recorded, a kit is dispensed from the specialized depot and sent directly to the subject. This is beneficial if only some patients are participating in the de-centralized trial, while others are still attending in-clinic visits.

3) Patient eDiaries and ePatient Related Outcomes (ePRO)

This module is extremely customizable allowing options for patients to record eDiaries/ePRO via the web or the phone. The questionnaire can be configured to ask all questions the subjects need to answer at home and on their own time. This allows more flexibility for the patients while allowing the study team to collect the necessary data.

 

Designing your clinical trial with the needs of patients in mind can result in increased compliance and decreased cost. Partnering with organizations that understand this goal can support your effort. Veracity Logic specializes in Interactive Response Technology (IRT/IWR/IVR/RTSM) systems – contact us to explore how we can help your next clinical trial.

 

For more info and an example of a decentralized clinical trial, go to:  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6072894/