June 6, 2017 -Newly released recommendations from the Clinical Trials Transformation Initiative’s (CTTI) Registry Trials Project pave the way for efficiently transforming patient registries into reusable platforms for conducting clinical trials.
CTTI recently unveiled a new set of recommendations to utilize existing and prospective patient registries to facilitate high quality, efficient registry-embedded clinical trials. The recommendations provide an essential framework for assessing and designing registries and can be applied to existing registries or used for developing new ones.
“The goal of these recommendations is to increase the practice of leveraging existing patient registries to facilitate high-quality clinical trials at lower costs,” said DCRI’s John Alexander, MD (pictured), co-chair, CTTI. According to him, existing registries collect data for the purpose of generating clinically usable information and evidence. “While registries have long been used to support non-randomized safety evaluations, their use for randomized or non-randomized efficacy evaluations is a newer practice,” he said.
“Depending on type-characteristics, some registries are more appropriate than others for conducting clinical trials. Regardless, CTTI’s Registries Trials Project has found a clear opportunity for registries to create a sustainable infrastructure to conduct clinical trials,” added Jules Mitchel, PhD, president, Target Health Inc. According to Mitchel, the new recommendations are the next step towards evolving how both researchers and sponsors think about clinical trial conduct, with faster, fit for purpose clinical trials as the end goal.
To determine if an existing registry is appropriate for embedding clinical trials, the new CTTI recommendations propose assessing whether the registry data demonstrates relevancy and robustness to support regulatory decision-making. The registry data must also have assurance of patient protections with the maintenance of patient and data privacy. To design a new registry suitable for embedding clinical trials, the CTTI recommendations advocate following software industry guidelines, as well as guidance documents provided by regulatory agencies, to assure that the registry complies with both industry and regulatory standards.
While the scale and scope of this project was limited to patient registries, CTTI’s multidisciplinary team believes that many of the principles and tools listed in these recommendations can potentially be applied to other health care systems and existing data sources, or those available within claims databases, to facilitate more cost-effective and competent clinical trials.
“We hope that with these recommendations, people will approach the design and conduct of clinical trials in a more systematic way that will ensure useful, high-quality data, including for FDA approval, on new devices and drugs,” Alexander said.
Established by the FDA and Duke University in 2007, the CTTI is a public-private partnership hosted by Duke University and based at the DCRI with a mission to develop and drive adoption of practices that increase the quality and efficiency of clinical trials.
Project team leaders included Duke’s James Tcheng, Celgene’s Dawn Flick, FDA’s John Laschinger, and Medtronic’s Ted Lystig. Other team members were Duke’s Sunil Rao and Emily Zeitler, Chunrong Cheng and Kristen Miller from the FDA, Christopher Dowd from the Cystic Fibrosis Foundation, Nicolle Gatto from Pfizer, Lauren Mclaughin from the Michael J Fox Foundation for Parkinson’s Research, Patient Representative Stephen Mikita, Daniel Mines from Merck, Magnus Petterson from AstraZeneca, Celgene’s Arlene Swern, and Mitchel. The current and previous project managers were Duke’s Sara Calvert and CTTI’s Steve Mikita, respectively.