Tubestop - Patient Input to Protocol Design

Description

Patient input to protocol design is the process of soliciting and incorporating the perspectives and experiences of patients into the design of clinical trials. This can be done through a variety of methods, including patient advisory boards, focus groups, and surveys. Regulators increasingly expect patient and or caregiver input to protocol design and execution plans.

Benefits:

Helps to ensure that the trial is designed in a way that is feasible and convenient for patient participation
Proactively identify potential barriers to participation and develop strategies to overcome them.
Helps to ensure that the trial is measuring outcomes that are important to patients.

DCT-specific Considerations/Inputs

Convenience: Patients should be able to participate in the trial in a way that is convenient for them. That includes increased optionality for trial participation - offering ways to participate that are not limited to a traditional research site. This may mean using remote monitoring technologies (e.g. data collection using wearables), conducting visits in the patient's home, or providing flexible scheduling options, and leveraging technology platforms for data collection directly from patients (eCOAs)

Accessibility: Patients should be able to access the trial regardless of their location, income, or insurance status. This may mean providing financial assistance, transportation reimbursement, or other support to enable their participation.

Support: Patients should have access to support throughout the trial process. This may include providing educational materials, a dedicated patient contact, and /or a technical support group.

Privacy: Patients must have their privacy protected throughout the trial process as dictated by regulations and local laws

Trust: Patients need to establish trust with the research staff and the trial process. Providing transparent information about trial participation expectations and duration, potential risks and benefits, and any financial or other support can help build trust.

U.S. FDA Final Guidance Document: Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

Patient Input to Protocol Design

Description

DCT-specific Considerations/Inputs

Tools

Regulatory Documents

FDA/U.S.

Europe/EMA

Reference Documents