CoLabs
Member-Driven Initiatives to Drive Progress in Adoption of Decentralized Trials
What Are CoLabs?
CoLabs are a more effective, inclusive, and adaptable system for conducting and managing DCTs. Our belief is that clinical trials should transcend the boundaries of traditional settings, becoming as accessible and patient-centric as possible. To bring this vision to life, we are pioneering the use of virtual platforms, retail pharmacies, local physicians, and community health centers. Our dedicated teams are constantly exploring innovative strategies, alternative site models, and streamlined processes for regulatory compliance and training. CoLabs is more than just an initiative—it's our commitment to shaping a more inclusive and efficient future for clinical trials.
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Who Can Get Involved?
DTRA Members can join any open seats on CoLab Teams at DTRA.
Current CoLabs in progress are:
● 1572 and Regulatory Document Recommendations for DCTs
● Alternative Site Models
1572 and Regulatory Document
Recommendations for DCTs:
Objectives
Streamlining Documentation:
We're committed to simplifying the process of completing regulatory forms, ensuring a smoother path to trial assessments.
Clarifying Oversight Responsibility:
We want everyone to know their role and responsibilities in these trials, fostering a transparent and accountable environment.
Promoting Resource Utilization:
By incorporating a range of local and virtual resources, we're making trials more accessible for participants and researchers alike.
Ensuring Quality and Compliance:
We recommend processes and tools to maintain adherence to Good Clinical Practice (GCP), prioritizing trial integrity and participant safety.
Engaging with the FDA:
We actively generate questions and considerations for discussions with the FDA to ensure our trials meet or exceed regulatory expectations.
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.
