May 21, 2018
The Clinical Trials Transformation Initiative (CTTI)—the first consortium to pull widespread stakeholders together, including the FDA, to hash through and try to fix large-scale problems that have plagued the clinical research space—has turned 10. What has it accomplished?
CTTI Executive Director Pam Tenaerts said she’s most proud of greatly elevating patient input in trials.
“One of the results of our patient engagement project was that now patients and patient advocacy groups sit at the table with us in the same numbers as sponsors and academia and as equal partners focused on writing protocols,” said Tenaerts.
Born from a collaboration between Duke University and the FDA, CTTI has completed 25 projects with the aim of increasing the quality and efficiency of clinical trials.
Jim Kremidas, industry veteran and executive director of the Association of Clinical Research Professionals (ACRP) believes that CTTI remains effective and influential because the FDA is one of its founding members.
“CTTI is unique in that they have regulatory involved,” he said.
And even though the FDA is in the room at CTTI meetings, Tenaerts said the gatherings are marked by raw honesty.
“With the environment we have created in our discussions, people feel very comfortable talking about why they do certain things, even with the FDA in the room,” said Tenaerts. “And what they say might not be what the FDA would expect them to say. But we’ve created this trust, and there is a realization that if you don’t know what the incentives are for continuing certain practices, you can’t know how to overcome those.
“Having everyone there all the time makes a big difference,” she added.
CTTI hasn’t slowed down. In 2017, the consortium issued five new sets of recommendations, many of which draw on recent advances in technology and data sciences to try to bring about improvements for clinical trials. CTTI recommendations were downloaded more than 26,000 times over the past year.
- Guidance for using mobile technology to develop viable novel endpoints for clinical trials.
- Best practices for assessing and designing registries for use in clinical trials so that the data can meet expectations for FDA review of new products.
- Actions that can be taken to strengthen the investigator site community and create an environment that sustains long-term investigator engagement.
- Guidance on planning for and making decisions about pregnancy testing in potential trial participants.
- Suggested ways to address the unique challenges of conducting pediatric antibacterial trials.
The quick uptake of transformative recommendations over the years has surprised her, said Tenaerts, who said people on CTTI project teams will take ideas they are working on with CTTI and start running with them right away, while they are still in process.
“I had assumed companies would want to wait to have final deliverables and firm recommendations from us and then get consensus from their project teams before thinking about changing the way they’re doing things, but I was wrong,” she said. “Through our surveys, people tell us that change often happens even before the recommendations from us are finalized.”
In its earliest days, CTTI began looking at conundrums faced in the trial monitoring process, and realized quality was suffering on the back end because not enough thought was put in at the front end of a trial during protocol design. So the group began a push for better protocol design.
“That involved making sure people focused on the things that matter in a trial, and not asking people to do too much through the course of a trial, as that will just create more errors,” said Tenaerts. “When we came out with our quality by design report, I think it represented a shift. Things changed.”
CTTI has also worked to bring significant change in the IRB space, pressing for sponsors to use one central IRB for multi-center trials rather than several local IRBs.
That has been a welcome change in the industry, said Kremidas. “The advantage of that is much faster study start-up times,” he said. “When you have multiple academic or regional IRBs, it takes so much longer.”
“We focus a lot on the why and the what, and now are working on the how in order to help people get there,” said Tenaerts.
CTTI is also creating a report about the state of clinical trials using data from clinicaltrials.gov. In July, the group is releasing its report on mobile technology, which focuses on the device side of capturing endpoints.
Tenaerts said that when CTTI got started, the plan was to affect sweeping change and then disband, but CTTI is still here.
“It’s not as if we’ve been Uber in the taxi industry. The industry we work in is so highly regulated with so much risk involved, transformation is just really hard,” she said. “We get frustrated sometimes, but if you think of how [in the field of prosthetics] we went from a wooden peg to the bladerunner that allows people to run 100 meters unbelievably fast, that was not in one fell swoop either. What we’re doing builds upon itself.”
-By Suz Redfearn