Alternative Sites CoLab
Clarifying Different Site Models and the Problems they Solve in Decentralized Clinical Trials
Clarifying Different Alternative Site Models and the Problems they Solve: SCOPE
These are recommendations on site selection and qualification- including key considerations for using alternative site models, training and oversight for a clinical trial.
Clarifying Different Alternative Site Models and the Problems they Solve: Deliverables
What problem does this model solve? Where can this model be utilized?
What are the Key Considerations:
- IP management and administration
- PI Oversight
- Patient Considerations (eg., privacy, comfort, etc.)
In-Home Trial Assessments
A research location that takes assessments directly to the patient (e.g. at home, school, work, etc)
● What problems does this model aim to solve in trials?
● How can this site model be used in trials?
Pop-Up Site
A research location where research assessments can be completed in a temporary location (such as a tent or short-term leased space e.g. screening events)
● What problems does this model aim to solve in trials?
● How can this site model be used in trials?
Retail Setting Site
A research site which provides convenient trial access to local communities
● What problems does this model aim to solve in trials?
● How can this site model be used in trials?
Mobile Research Site
(Site on Wheels)
A research location which provides mobile trial access; it can go where the patients are
● What problems does this model aim to solve in trials?
● How can this site model be used in trials?
Patient Service Center
(Lab-based Research Site)
A place where patients go for lab test sample collection e.g. Quest / LabCorp locations
● What problems does this model aim to solve in trials?
● How can this site model be used in trials?
Health Care Provider Site
An additional research location where a patient is already receiving care
● What problems does this model aim to solve in trials?
● How can this site model be used in trials?
Integrated Research Organization
A clinical research infrastructure that integrates clinical trials with the patient care continuum
● What problems does this model aim to solve in trials?
● How can this site model be used in trials?
Alternative Site Models: Objectives
Defining Best Practices:
We strive to identify and recommend the most effective study designs and therapeutic areas for decentralized clinical trials conducted in alternative sites.
Optimizing Site Selection:
We're developing systematic guidelines to qualify and select suitable locations for trials, helping to ensure that each site can offer the best support to participants and researchers.
Enhancing Staff Training:
Recognizing that alternative site staff may come from a variety of backgrounds and experiences, we're creating tailored training materials and tools to ensure they are well-equipped to meet the unique challenges of decentralized trials.
Assuring Quality and Compliance:
We're working on process recommendations and tools to ensure that all trials conducted in alternative sites meet the stringent requirements of Good Clinical Practice (GCP), prioritizing safety, ethics, and data integrity.
Engaging the FDA:
Our initiative actively prepares a list of vital questions and considerations for discussions with the FDA, ensuring our practices meet regulatory standards and shaping the future of clinical trials.
