Feasibility and Investigator Selection
The purpose of the Feasibility and Investigator Selection stop is to (1) perform a feasibility study/test to ensure the Clinical Trial can be successfully conducted (recruiting and retaining patients, collecting data accurately and completely, in compliance) and (2) select appropriate Principal Investigator(s) to conduct and oversee the trial for patients under their care.
Description
The availability of a suitable study population: The study population must be large enough to provide statistically significant results, and it must be representative of the population that the study is intended to benefit.
The availability of a suitable study drug or intervention: The study drug or intervention must be safe and effective, and it must be available in sufficient quantity to conduct the trial.
The availability of qualified investigators and staff: The investigators and staff must have the necessary expertise and experience to conduct the trial, and they must be available to commit the time and effort required to complete the trial. Additionally in DCT Feasibility it's important to consider:
The study design: Some study designs are more amenable to decentralized clinical trials than others. This is dependent on both the nature of the investigational product (IP) and the study assessments planned. Ideally, the protocol is designed to optimize the use of DCT technology and services. The willingness and availability of study site staff to participate in trials using DCT methods. Alternative site models may be appropriate for the trial, and must be appropriately assessed to ensure protocol compliance and appropriate conduct is possible.
The patient population: The patient population that is eligible for the study must be able/ willing to participate remotely for at least some trial visits or assessments. The goal is to ensure that the trial design aligns with patient and site preferences to allow more patients to participate.
The availability of technology: The study sites and participants must have access to the necessary technology to collect and manage data remotely. This includes electronic devices, remote monitoring systems, and data management software.DCT-specific Considerations/Inputs
Ease of implementation and willingness to adopt by sites investigator/institution, and Regulatory Authorities/ Ethics Committees.
Verify DCT conduct capabilities:
Collaborate on Regulatory Gaps
SCRS Best Practices for Site Adoption
EMA Recommendation on Decentralized Elements in Clinical Trials
Patient Population Preferences
Consider whether the DCT methodologies planned fit with patient preferences and how to offer optionality to patients to use them. This may be a separate feasibility study than with sites, and may be part of the Patient Input to Protocol Design stop.
Regulatory Documents
FDA/U.S.
U.S. FDA Final Guidance Document: Conducting Clinical Trials With Decentralized Elements Guidance for Industry, Investigators, and Other Interested Parties - September 2024
ViewU.S. FDA Guidance: Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
View21 CFR Part 312 Investigational New Drug Application
ViewState Telehealth Laws and Reimbursement Policies Report, Fall 2024
ViewFDA Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency
View