Decentralized Clinical Trials
Clinical Trial Services
Decentralized clinical trials (DCTs) are becoming increasingly popular, with the increased use of electronic systems and novel techniques for centralized monitoring. In decentralized clinical trials, study activities may take place at locations other than traditional trial sites. In September 2024, the FDA issued a guidance for conducting clinical trials with decentralized elements. This blog will summarize the advantages of decentralized trials and suggest ways to overcome challenges.
Aspect | Advantage | Challenge |
Safety | The local health care provider is more familiar with the patient’s medical history and can respond to urgent events in-person. | There could be delays in reporting and proving information to the investigational site if the patient is seen locally for an adverse event. |
Data | Increased patient diversity allows for better representation of the patient population. | Increased need for data security with the increased number of data transfers and users. Increased training is needed for data collection consistency. |
Enrollment | Access to more patients can improve enrollment. | Some patients may not have access to local healthcare or have the necessary technology literacy. |
Retention | Convenience of virtual or local visits may increase patient retention. | Patients may prefer face-to-face interactions. |
Cost/time efficiency | Standard of care tests and procedures that do not require special equipment or training can be done locally. | Depending on the health care provider and location, it may be less expensive to reimburse for patient to travel to the investigational site. |
Advantages
Some activities of the study may be more cost and time efficient if performed at a local healthcare provider or virtually. Standard of care and assessments that do not require specific product or protocol training, such as a routine blood test, can be performed at any local health care provider or mobile clinic.
Decentralization contributes to patient safety by enabling access to local resources to provide a quicker response to safety concerns and more frequent follow-up if needed. A patient’s local healthcare provider may be more familiar with that patient’s medical history than a principal investigator at a more distant, larger facility.
By allowing participants to have more local experience, DCTs can expand access to more diverse patient populations including those in rural areas. Closer locations and at-home visits are beneficial for patients with limited mobility or patients with caregiver responsibilities. However, some populations may not have access to healthcare technology or may not feel comfortable using it, which may deter participation. This can be mitigated through providing the technology and training during an at-home visit where the patient may be more comfortable.
Decentralized trials offer more convenience for the participants by reducing travel to study sites. Study participants can also interact virtually with study personnel. This increased accessibility can increase participation willingness and retention.
Overcoming Challenges
Clear communication and defined roles are essential to a successful DCT. If a patient is seen for an adverse event at a local clinic, this needs to be reported to the appropriate parties. Outlining each party’s responsibility will help ensure that the activities are being performed per the protocol.
With decentralized clinical trials, participant retention can vary. Some patients would prefer virtual or local visits, whereas others may prefer on-site visits with study personnel. This can be addressed through designing a hybrid DCT of traditional on-site visits and alternate locations or virtual visits tailored to the patient’s preferences.
Another challenge is data management. Data consistency can be improved by providing standard procedures (e.g., imaging guidelines) so that data is collected and processed uniformly across sites. With the increase in data transfer between different sites, data security should be considered proactively in managing access and processing. The FDA guidance outlines the information that should be included in a data management plan for DCTs.
With data originating from more locations, monitoring can seem overwhelming. A monitoring plan should be tailored to the unique considerations of a DCT. For example, centralized monitoring can aid in detecting systemic errors if frequent on-site visits are not feasible.
Conclusion
Incorporating decentralized elements in a trial provides the opportunity to increase enrollment, retention, and efficiencies while still ensuring patient safety and data integrity.
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