The clinical trial ecosystem wasn’t built to handle the demands of a global health crisis and isn’t generating the level of evidence required for regulatory decisionmaking, says an FDA-backed coalition that is developing a five-point strategy for making trials more effective and their data more relevant.

The current system is “well-intentioned but flawed” and is too slow, too expensive and not reliable, according to the Clinical Trials Transformation Initiative (CTTI), a public-private partnership established in 2007 by the FDA and Duke University.

All stakeholders need to join in an effort to create a stronger system, said John Alexander, CTTI co-chair and professor of medicine/cardiology at the Duke Clinical Research Institute. “Our clinical trials ecosystem is incredibly complicated,” said Alexander, “with a myriad of stakeholders and a number of conflicting interests. There is a tremendous amount of work that needs to be done to get the multiple stakeholders aligned.”

CTTI has unveiled its five-point vision for 2030, saying its aim is to develop clinical trials that are:

• More patient-centered and patient-accessible;
• Fully integrated with health processes;
• Designed with a quality approach;
• Able to maximally leverage available data; and
• Focused more on improving public health.

In pursuit of those goals, the organization has been developing tools, resources and initiatives to improve clinical trials in several areas, beginning with using quality by design to write better protocols. In a CenterWatch webinar last week, CTTI said it also supports moving recruitment planning up in the timeline to coincide with the trial design process and take into account evidence-based trial feasibility, site selection and communication strategies.

A second area of focus for the partnership — patient engagement — includes a financial model that can be used to estimate its effect on key business drivers, such as cost, risk, revenue and time, demonstrating that patient engagement can have a considerable impact on the bottom line. CTTI has developed an online prioritization tool that patient groups and sponsors can use to identify high-value opportunities to work together.

CTTI plans to sharpen its focus on investigators and sites by addressing issues associated with the high turnover rate for investigators and improving good clinical practice training for investigators and site staff. The partnership’s position paper on training recommends essential elements for investigator qualifications, three-year training cycles and a focus on recurrent areas of noncompliance.

A fourth area of focus — digital trials — addresses development of novel endpoints, use of technology for data capture, overcoming both real and perceived challenges to conducting decentralized trials, and engaging patients and sites in planning and conducting mobile clinical trials.

The focus on novel clinical trial designs includes plans to apply real-world data in a way that enhances eligibility criteria and recruitment in clinical trials, which CTTI hopes will lead to increased efficiency, shorter timelines and better patient access to clinical trials.

CTTI’s focus on ethics and human research protection includes calls to improve the review process through the use of single IRBs for multicenter clinical trials; clarifying and standardizing the role of data monitoring committees; and improving the quality and efficiency of safety reporting in clinical trials.

The organization is in the process of writing and publishing its five-point strategy for clinical trials in 2030, Alexander said, and is interested in hearing how its ideas resonate with other stakeholders.

“CTTI is one player in this,” he said. “We have no aspiration to be driving change ourselves. We fully expect to be engaging with others to try to bring alignment in vision, and then hopefully some alignment in modification or transformation of our clinical trials ecosystem over the next decade and then on an ongoing basis after that.”

CTTI’s Executive Director Pamela Tenaerts credits the COVID-19 pandemic with some of the forward movement in clinical trial improvement. “Obviously, COVID revealed a lot of the cracks that we all knew were in the clinical trials ecosystem,” Tenaerts said. “All of those cracks are open now and for everybody to see. COVID has also been the great accelerator because we have been able to all of a sudden agree [on several issues].”

She said it remained to be seen whether changes enacted during the pandemic would continue to contribute to needed improvements in the industry. “Some of the changes made might not be perfect, and some of the changes we had to do were not perfect because we had to do them under the duress of the pandemic,” she said. “The general consensus is that it accelerated our vision by leaps and bounds. In some ways we’re doing things now that we thought we wouldn’t be doing for years, and in other areas we still have a ways to go.”

“It’s been a really interesting — and sad — six to nine months, but it shows that clinical trials can be done differently and should be done differently in many cases.”