Emergence of Direct to Patient in DCTs Chain

Decentralization in clinical trials is gaining popularity due to new techniques and technologies. Decentralized Clinical Trials (DCTs) are based on the Direct-to-Patient (DtP) supply paradigm, allow to send trial samples and medication straight to the participant's house. This approach benefits sponsors and participants, and can be built using virtual or hybrid visits. The rising need for solutions to support the development of ground-breaking treatments is driving the appeal of DCTs. With Depp clinical trials, the patient is given more authority and control over their own health. A qualified medical professional may be involved to administer the therapy or gather samples and vitals.

Furthermore Clinical Trial Supply Forum highlights the growing trend and scope of the Depot-to-Patient (DtP) approach in decentralized clinical trials (DCTs).

Types of DtP Model:

• First, supplies are shipped to the patient from the site/depot and remote help is offered via conversations, videos, and tracking.
• Taking care of patients in the clinic, overseeing inventory at the sites, and keeping track of who is and is not involved in the DtP experiment comprise the second procedure.
• [Per patient per visit vs. per site] Shipment expenses dramatically increase, with the patient, the courier has direct communication.

Advantages:

They offer a number of significant benefits

• Enhancing patient convenience and reducing trials burden.
• Improved patient recruitment and retention.
• Broadening access to underrepresented and geographically diverse population.

Disadvantages:

• A prevalent issue in global clinical trials is the disparity in regulatory mandates across different countries.
• The variation in medical practitioners' duties and responsibilities based on regional dynamics further complicates the process.
• Furthermore, the capabilities of healthcare systems vary throughout nations. More developed countries, for instance, might have the financial capacity to manage home-based care.
• Meanwhile, implementing DtP clinical trials will be challenging in other areas with little funding for healthcare and a shortage of medical professionals.
• Working within strict time constraints is a requirement of DtP clinical trials.
• The medication must be shipped to maintain product safety and quality.

DtP Globally:

• The use of decentralized clinical trials (DCTs) has accelerated significantly in recent years.
• Depot-to-patient (DtP) models are increasingly employed for the distribution of biological specimens and investigational products (IP).
• Due to its numerous benefits, DCTs have gained widespread recognition and adoption by Contract Research Organizations (CROs) and pharmaceutical companies.
• In response to the Covid-19 lockdown measures, implementing a decentralized strategy made sense, allowing investigational drugs to be delivered directly to trial participants.
• This shift has led to a notable increase in the number of trials using DCT models.
• Data shows that the number of trials incorporating this design feature has risen sharply in the past two years compared to previous years.

EMA Recommendation:

European Medicines Agency (EMA) published recommendations on the use of DCT elements. Three main topics are covered in the guidelines:

1. Risk-benefit analysis
2. Patient safety
3. Patient and investigator inclusion

• The EMA emphasizes that the development of decentralized clinical trials (DCT) protocols should prioritize the patient’s perspective, with DCT elements included only when appropriate.
• The industry is still facing challenges in delivering investigational medical products (IMPs) directly to patients (DtP).
• A recent survey by Sharp Clinical, a clinical supply service provider, found that 45% of pharmaceutical companies cited clearer regulations on DtP as the biggest obstacle to improving this process over the next five to seven years.
• Despite these hurdles, Interactive Response Technology (IRT) is helping to overcome challenges in DtP delivery.
• Additionally, Sharp Clinical provides a Clinventory inventory management platform to assist sponsors in managing this process more effectively.

Challenges and Risks in Supply Chain:

Logistics and Coordination of Shipping:

• DtP experiments present serious dangers to the supply chain, including shipping logistics and coordination.
• Delivery problems may arise from courier delays, which have a 2-3 hour arrival window relative to the site's operation hours.
• Nursing services may find this difficult, particularly if everyone shows up at the same time. Concerns about patient privacy, such asking for various shipping addresses, make matters more difficult.
• There is an added risk of problems when a pharmacist gives a patient a prescription for medication directly.

Lack of Traceability and Communication:

• The study drug's location is crucial for DtP trials, posing a supply chain risk. Sponsors rely on CMOs for this information, often using Excel for human error.
• Precise traceability is essential for handling temperature deviations, canceled shipments, and returns.
• Communicating issues between sponsors and CROs can be challenging.
• Without complete supply chain insight, developing emergency measures for recalls becomes more challenging.

Minimizing Face to Face Interaction:

• Reduce face to face interaction may affect trust and motivation between patient and healthcare.
• Monitoring adherence to protocols can be difficult in remote settings.

Lack of Automation in the Process:

• In order to solve challenges specific to Direct-to-Patient (DtP) scenarios, Interactive Response Technology (IRT) is being developed.

Development and Management:

• Early challenges in decentralized clinical trials included delivering medication at the site level instead of using the DtP model.
• This required significant changes, such as transitioning from dispensing medication directly to postponing distribution until the patient signed proof of delivery.
• These adjustments were necessary to ensure proper medication handling and compliance.
• To address these issues, technology has been developed to track and verify the delivery process.
• This technology ensures that the product reaches the correct patient in the right condition.
• Additionally, it maintains a secure chain of custody, proof of delivery, and temperature data, all linked back to the site.

Clinical Trial Supply Forum 2025:

At the next Clinical Trial Supply Forum, World BI, conferences will talk about innovative supply solutions for clinical trials by adding Direct to Patient Approach and provide awareness about the most recent developments and uncover the challenges to improve the use of Depp in DCTs.

Participants will have the opportunity to engage in discussions, share ideas, and learn about the most recent advancements and industry best practices. The goal of this conference is to provide an extensive platform for discussing the various opportunities and issues related to Clinical Trial Supply.