A YPrime blog by:
Justin Jaeschke
Senior Vice President, Commercial Operations
As the decentralized clinical trial (DCT) movement continues to gain momentum, direct-to-patient (DtP) solutions have evolved as an important piece of the broader DCT framework. These solutions represent a significant advancement in clinical research by expanding access and participation. Through the integration of innovative trial designs and cutting-edge technology, the field is reaching more diverse patient populations and offering more convenient participation options than ever before. A DtP strategy, which involves delivering study drugs directly to patients, supported by advanced technological solutions, has greatly enhanced supply chain management and accountability. It has also proven highly effective in improving patient recruitment and retention.
The use of decentralized technology in clinical trials is not new. However, the integration of technology into the DtP model has greatly improved trial outcomes. By leveraging decentralized technologies, such as eConsent, ePROs, telehealth, and DtP, decentralized solutions have streamlined processes and significantly reduced the burden on patients. This has resulted in higher patient satisfaction levels and better compliance rates, leading to more accurate data collection. 
DtP solutions enable researchers to reach a wide pool of potential participants, including those living in remote or rural areas where access to traditional clinical trial sites may be limited. This promotes diversity in clinical trials and allows for a more representative sample of the population to be included, leading to more accurate and generalizable results.
Implementing DtP solutions requires careful planning and execution. Depending on the model, patients, sites, and even couriers must receive proper training and support to ensure they are comfortable using the technology. In addition, strict adherence to data privacy laws and regulations is crucial to maintaining patient confidentiality and trust. Therefore, it is important for research teams to work closely with technology providers who have expertise in clinical trial operations and data security.
The Benefits of a DtP Model
Traditional clinical trials center around patients visiting investigator sites. A DtP strategy, on the other hand, aligns with a decentralized clinical trial model, permitting processes and technologies to differ from traditional clinical research site-based methods. This approach includes shipping investigational medicinal products (IMPs) and clinical supplies right to the patient’s doorstep.
DtP trials have proven beneficial for patients with geographic limitations, those without proximity to major academic institutions or investigator sites, and patients with caregiving responsibilities, immobility, or severe health conditions.
For sponsors, DtP trials can enhance patient access, improve retention, increase operational efficiency, reduce drug waste, and lead to expedited completion times with more reliable results.
The Role of Technology in DtP Trials
Despite the numerous advantages, DtP trials come with unique complexities:
Modern interactive response technology (IRT) solutions can provide flexibility to align with several DtP models, depending on the approach that is best for your individual protocol or program. Expect a modern IRT to provide a clear history of when materials are moved—from allocation to the patient through return and reconciliation.
A seamless IRT solution offers features such as drug order management, support for hybrid/remote/on-site visit schedules, electronic drug accountability, remote CRA monitoring, depot return options, and reconciliation reporting, ensuring that DtP trials are always inspection-ready.
Over the past decade, decentralized strategies, including DtP, have transformed clinical trials, making them more patient-centric. Today’s clinical trials require robust technology solutions for effective accountability and quality management. As experienced technology providers continue to overcome practical and logistical challenges, the future of DtP trials remains promising, fostering better patient participation and more reliable results.