Wide inconsistency observed among clinical trials’ startup time: Tufts report

Male doctor in white lab coat
No single-source platform for site identification and the lack of a centralized ethics review pathway are reasons for inefficiencies in clinical trial initiation, a new Tufts study reported. (Getty/Saklakova)

Clinical trials on average take about six months to go from site identification to study startup, but there are wide differences between using new sites versus repeat sites and between CROs and biopharma companies, a new report by the Tufts Center for the Study of Drug Development discovered.

Sponsored by cloud-based clinical study startup solutions provider goBalto, the study focused on the cycle of site recruitment and the challenges the industry is facing. It was recently published in Therapeutic Innovation & Regulatory Science, the official scientific journal of the Drug Information Association (DIA). In about two months, the study collected nearly 600 responses from employees working in about 400 companies, with about 80% of respondents having more than six years of experience in clinical operations.

Overall, CROs take much less time to reach study startup than sponsors, the paper reported. To be specific, compared to sponsors, CROs take 20% (5.6 weeks) less time to start a clinical study at sites they’ve worked with before, and the gap rose to 28% (11 weeks) when new sites are involved.

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In addition, organizations with a centralized function team dedicated to site-related activities, representing about half of the respondents, invested more than twice as much in technology than did those without such a team, and 80% of respondents who have invested in new technology reported time savings.

“As stakeholders are increasingly aware that better study startup processes are linked to shorter clinical timelines, the emphasis has been shifting in that direction,” said Sujay Jadhav, goBalto's CEO, in a statement. “The increasing use of technology and impact on cycle time reductions is a very positive industry trend.”

RELATED: Electronic data capture systems not speeding clinical trials as expected: Tufts report

However, it’s also worth noting that those dedicated teams showed no significant advantage in study startup cycle time working with repeat sites and only had a 2-week (10%) advantage working with new sites.

What’s more, for each step of the entire cycle, which includes site identification, selection and final activation, around 10% to 30% of the companies said the process is taking longer than it did three years ago. The lack of a single-source platform for site performance was widely cited as the reason for slowing down the site identification process.

From early 2016, TransCelerate BioPharma has offered a “Shared Investigator Platform” that acts as an access point for interaction between the site and clinical trial sponsors. GoBalto also has “Select,” which provides sponsors and CROs with a data-driven approach to selecting sites. But Craig Morgan, head of marketing at goBalto, said there're still many issues ahead. 

First is setting a standard definition of performance against which all sites can be ranked. “What defines performance? Relevancy, timeliness, quality, cost, experience, subject enrollment and retention,” said Morgan. “Also if the SIP initiative fails there is no incentive for vendors to freely share information on high performing sites.”

Almost all respondents also rooted for centralized ethics review to accelerate site activation. The new U.S. Federal Policy for the Protection of Human Subjects already added a significant change that requires federally funded multisite clinical trials to use a single institutional review board. It will officially be effective on Jan. 20, 2020.

Compared to an original Notice of Proposed Rulemaking HHS and 15 other federal departments and agencies brought forth for public comments in 2015, the final rule does not extend to clinical trials that are not federally funded. Using several regional IRBs for multicenter trials often means different document requirements and in some cases even inconsistent verdicts, which could cost a study more time to commence.

Editor's Note: The story has been updated with comments from goBalto's Craig Morgan.