New Trial Innovation Network Offers More Opportunities for Clinical Trials
URMC researchers will soon be able to take advantage of a new clinical trial network offering expertise on trial design and development as well as participant recruitment and retention. Researchers can propose a clinical trial for inclusion in the Trial Innovation Network, become a participating investigator in an existing multi-site trial or request consultation on clinical trial design through the network.
The Trial Innovation Network is the result of a major new national initiative to improve the nation's research infrastructure to make clinical trials faster, better, and more efficient. According to recent estimates, it can take 12 or more years to get a new therapy from discovery, through clinical trials, and onto the market. That’s a very long time – especially for patients who could benefit from these drugs.
“The Trial Innovation Network will increase research opportunities for patients in all areas,” said Robert Holloway, M.D., M.P.H., chair of Neurology and medical/faculty director of the Trial Innovation Network Hub Liaison Team at URMC. “We don't know how many trials the network will host, but there will be many - from neonatal to geriatric trials and various conditions from rare to common diseases.”
Building off previous clinical trial network models that are devoted to specific diseases, the Trial Innovation Network speeds the process by connecting institutions across the U.S. to share resources, recruit more trial sites, and maximize the number and diversity of trial participants. The Trial Innovation Network is part of the Clinical and Translational Science Award (CTSA) Program and will redefine the 64 CTSA hub institutions as clinical trial expert sites.
Clinical trials run through the network will utilize a single Institutional Review Board (IRB) reliance model and the standard master site agreement developed for the network. This will streamline trial implementation by minimizing time devoted to IRB review and contract negotiation, allowing researchers to get clinical trials underway quicker.
The network will be a vast resource offering assistance with all aspects of clinical trials - from basic questions around study design, all the way through comprehensive consultation in developing a protocol and assistance conducting clinical trials. CTSA institutions and their researchers can leverage the network by becoming an enrolling site on clinical trials that come from the network or by proposing and leading a clinical trial in the network. All types of clinical studies can be proposed including interventional or observational and behavioral or biomedical.
The network was launched in October of 2016 and is still in its infancy, but 33 proposals have been received to date and clinical trials are anticipate to start in early 2017. URMC researchers interested in utilizing the Trial Innovation Network must be current on Good Clinical Practice training and must work with our Hub liaison team to refine and submit proposals to the network. Once the proposal is approved by the network the investigator must obtain funding from the appropriate NIH institute or center to conduct the study.
To learn more about the Trial Innovation Network, visit the website.
To contact the Hub liaison team and get started with a proposal, email the CTSI Research Help Desk.
Michael Hazard | 12/23/2016
