The Trial Innovation Network (TIN) is a new collaborative initiative within the CTSA Program and is composed of three key organizational partners – the CTSA Program Hubs, the Trial Innovation Centers (TICs), and the Recruitment Innovation Center (RIC that seeks to address critical roadblocks in clinical trials and accelerate the translation of novel interventions into life-saving therapies). Through the CTSA Program, the Boston University Clinical & Translational Science Institute (BU-CTSI) has become a member of the TIN. Through our collaboration, we will be able to provide investigators with a wide range of services and consultations that are designed to assist investigators in the development of proposals into protocols; execute trials better, faster, and more cost-efficiently but, importantly, to be a national laboratory to study, understand and innovate the process of conducting clinical trials.

• SMART IRB Reliance – Single IRB  model system designed to ease common challenges associated with initiating multisite research
• Master contracting system
• Streamlined protocols – Master protocol and clinical research form (CRF) templates
• Harmonized IT tools and approaches (e.g., tools for recruitment using the electronic health record)
• Data-driven recruitment strategies

The Trial Innovation Network currently provides services for multi-center clinical trials and studies

• Any full time faculty member at Boston University
• The investigator must obtain written approval to submit a proposal from the BU- CTSI prior to submission to the Trial Innovation Network
• If the investigator is proposing work that will be supported by an NIH Institute, he or she must contact a Program Officer at the partner NIH Institute before submitting a proposal to the Trial Innovation Network. The NIH program officer should provide written documentation to the investigator that the proposed application is aligned with the mission of the Institute and that the Program Officer is aware of the request to seek support from the Trial Innovation Network.

• Investigators must contact the BU-CTSI Hub Liaison Team to discuss their proposal and obtain a brief consultation prior to submission. Consultation with the CTSA Program Hub PI/Trial Innovation Network Hub Liaison Team is required.
• Proposals submitted to the Trial Innovation Network should have a strong scientific hypothesis and should be responsive to each section of the Proposal Intake Form. Detailed information on the proposal form can be found at the Trial Innovation Network website.
  • Investigators interested in submitting a proposal should contact Helia Morris, BU-CTSI Executive Director at hmorris@bu.edu or 617-638-4542
• Please see the Proposal Submission Resources for more information on submitting a Network proposal.

The current state of clinical trials – across the board and in all disciplines – presents many opportunities for improvement. The Trial Innovation Network is designed to be a complementary resource and an option for investigators and NIH Institutes to optimize the clinical trials enterprise.

Added Value for Investigators:

• One-stop shopping to implement clinical studies so investigators can focus on the scientific question
• TICs and RICs – expertise in operational innovation and operational excellence
• CTSA Program hubs – broad expertise; large, diverse patient populations
• More competitive clinical trials applications submitted to NIH ICs

Added Value for NIH Institutes and Other Partners:

• Shared goal to complete trials and studies on time and within budget
• Shared NIH mission to innovate and transform clinical trials and optimize stewardship

The BU-CTSI has established a TIN Hub Liaison Team, which is responsible for coordinating with the TIN. The TIN Liaison team will use their experience and knowledge of the local environment to coordinate Trial Innovation activities at BU and will coordinate activities among other multi-site study stakeholders.

TIN Hub Liaison Team

Role	Team Member
Principal Investigator	David M. Center, M.D. Associate Provost for Translational Research
Medical Director	George O’Connor, M.D Professor, Boston University School of Medicine
Administrator/Project Manager	Helia Morris, MSN Executive Director, BU-CTSI
Single IRB Point of Contact	John Ennever, MD, PhD, CIP Director of the Office of the Institutional Review Board and Human Subjects Protection

After your proposal is submitted to the Trial Innovation Network it will be reviewed by the Proposal Assessment Team. The goal of the TIN is become a resource for the scientific community that will foster excellence and innovation in clinical trials and studies.