DtP, or Direct-to-Patient clinical trials, are a type of decentralized clinical trial (DCT) where aspects of the trial are conducted at locations outside of the investigator site (e.g., patient’s home, work place, travel destination) and may be executed through the use of mobile/local healthcare providers, wearable/sensor devices, telemedicine, eConsent, etc. DCTs may involve any phase, and most have at least 1 investigator with a physical location.
The main benefits of DtP are to improve enrollment and ease the burden on patients to access trial sites. While the concept of DtP is not new, clinical trial models and supporting infrastructure need to shift.
Three Types of DtP Models
There are three types of DtP Models: Depot-to-Patient, Site-to-Patient and Hybrid.
The IMP is shipped directly from the main or sub depot (e.g. central pharmacy)
to the patient home. Nurse services may be added.
The IMP is shipped from the depot to the site, and from the site to the patient home.
A mix of DtP/traditional site visits. In other words, when patients have site visit(s) and also
receive IMP at the home (from depot or other site) in other visits.
Role of Randomization and Trial Supply Management (RTSM)
Technology in Direct-to-Patient Trials
RTSM systems play a critical role in ensuring the right medication gets to the right patient at the right time. Leveraging an RTSM can enable DtP trials, effectively mitigating the supply chain risks mentioned above and ensure the integrity of a DtP trial. The use of an RTSM dramatically reduces the risk of shipment coordination. Shipments can be generated automatically or manually and the forecasting algorithm can manage different methods of shipping. Inventory can be managed on all levels.
Process in the RTSM
Prancer RTSM™ Offers DtP To Support Any Strategy
With 100% configurability, sponsors can choose from the following DtP capabilities. These can be switched on or off at any time, pre or post go-live, depending on the study needs:
• Any DtP model or combination thereof at the patient, study, site, visit and country level. (This is especially critical when adhering to different rules and regulations across the globe.)
• DtP for all or just selected visits
Impact of COVID-19 on Patients and Sites
In the midst of this outbreak, there are countless immunocompromised individuals still traveling to clinical sites to participate in trials to receive critical and sometimes life-saving treatments. See first-hand how the novel coronavirus is impacting clinical trial participants and research sites alike.
SCRS Podcast Featuring 4G Clinical:
"Sponsors are Transitioning to Direct-to-Patient Trials – Are you Prepared?"
In an effort to ensure clinical trial continuity in the midst of COVID-19, more and more sponsors are moving towards Direct-to-Patient models to ensure patient access to medications. In order for sites to adequately prepare for this new approach, it is imperative to understand current trends and challenges as sponsors are approaching these models differently depending on their study and supply chain considerations.
Direct-to-Patient Clinical Trials
Leveraging Modern RTSM Systems to Overcome Supply Challenges
Clinical Supply Planning Optimization
Addressing Gaps in People, Process and Technology to Drive Supply Chain Efficiencies
Disrupting Study Start-Up
How Agile RTSM Software Development Accelerates the Clinical Trial Timeline