Four Challenges that Researchers face with Direct-to-Patient Trials


Direct-to-patient (DTP) trials bring the investigational product to a patient’s home, eliminating the need to travel to a site. This approach has improved patient recruitment rate and retention. It also reduces patients’ exposure to communicable diseases and the overhead costs associated with on-site trials. That’s why players in Veristat clinical studies—a sponsor and clinical research organization—are increasingly adopting DTP models.  While a DTP clinical trial has many benefits, it has four main challenges. This article will reveal these challenges to give you more insights into DTP trials.

DTP trials complicate drug distribution and management

In traditional clinical trials, drugs were easily distributed and managed since they were stored in a central research site. Storage and stability standards can easily be met. On the other hand, DTP trials require the investigational product to be shipped to each participant’s home, which is a great challenge. The distribution to each patient’s residence can mean increased costs. Additionally, investigators are not guaranteed that the storage and stability requirements will be maintained at the patient’s home. It’s also difficult to detect drug tampering and unauthorized access in direct-to-patient trials. Most importantly, delayed delivery of drug refills can easily interrupt the clinical study.

Cybersecurity is a huge concern in direct-to-patient trials

Electronic submission of patient data is at the core of DTP trials, which raises cybersecurity concerns. Management stakeholders in decentralized clinical studies must follow protocols that comply with data protection regulations. This is an additional challenge since a data breach would mean theft of sensitive trial information, legal issues, and study interruption. For sponsors, this could mean losing millions of dollars spent on a specific clinical trial. A cyber-attack in a DTP trial goes beyond data theft. Cybercriminals could tamper with wearable medical devices, destroying critical information and, in worst cases, putting patients’ health at risk.

Compliance challenges

Apart from cybersecurity regulations, there are other compliance rules DTP trials face. For example, wearable and biometric devices used in collecting participant information are still in the initial development stages. As a result, there are strict regulations around these technologies. Validation by regulatory bodies is required before using them. The validation process could mean delayed clinical trials since it would take longer to start the studies.

Besides that, DTP trials face supply challenges. For example, not all couriers have the technologies necessary to keep patient data genuinely blinded, which is a must in the U.S under HIPAA legislation. Suppliers must adhere to patient privacy legislation. For example, courier drivers must NOT enter the patient’s home, listen to patient feedback, or comment on conditions. These strict regulations make DTP trials highly vulnerable to non-compliance.

Increased patient burden

While DTP trials come with many advantages, they introduce some challenges to patients. For example, participants have to learn to take the study drug themselves and interact with investigators remotely. Participants who never used remote communication tools may find this an inconvenience. Other additional tasks that may be a burden to the patient include; participants are forced to determine instances when the investigational product is damaged, out of temperature, or missing after delivery. Also, patients have to confirm received shipments by, for example, calling the site or updating the status.

Direct-to-patient trials have many advantages. However, as with everything else in life, they have downsides. Before implementing a DTP approach, clinical trial leaders should evaluate its pros and cons. The management stakeholders should ensure they can meet compliance regulations to avoid legal issues.

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