Survey Shows Sites May Face Steep Learning Curve on ICH E6(R3)
Adapting to the quality and risk management components embedded in the new ICH E6(R3) guidelines may present challenges for sponsors and providers, but it’s sites that may find the task particularly daunting, findings from an Avoca survey show.
The 341-respondent survey conducted earlier this year focuses on sponsor, site and provider awareness of the new standards ICH E6(R3) presents and their perceived impact.
“We found that there is an awareness, but not necessarily familiarity with the specifics,” Crissy MacDonald, vice president of client delivery for Avoca, told attendees at this year’s Avoca Quality Consortium (AQC) Summit.
While sponsors and providers both appear to have about an equal level of understanding of ICH E6(R3), a majority of sites had merely heard about it and weren’t knowledgeable on its specifics, MacDonald said. In some cases, sites even had the wrong idea about what the guidelines entail, she added. This, in addition to the fact that two-thirds of respondents believe it will significantly add to site burden, may indicate that sites could be blindsided by the guideline’s actual effect on trial operations as soon as this fall, when it’s anticipated to be finalized.
Site respondents appeared aware of the changes but unclear on the specifics of trial administration, MacDonald said.
“What we know of the upcoming guidance does actually put some additional administrative onus on sites. There does appear to be a little bit of a blind spot in terms of expectations there.”
Stakeholders were also split on the effect the guideline will have on their overall clinical trial processes, whether those were related to the design or execution of trials. While nearly all signaled it will change their trial operations in some fashion, 56 percent feel it will have a moderate-to-significant impact while 44 percent believe it will have little to no effect.
On the other hand, there was a much stronger consensus amongst stakeholders that impact will be positive, not negative, especially regarding the guidance’s modifications to roles and responsibilities. One sponsor, for instance, cited more dedicated sponsor-investigator communications on potential service providers and roles and responsibilities as a plus, while a provider respondent said they expect the guidance to improve transparency between sponsors, vendors and sites while reducing trial complexity. Similarly, a site responded that the guideline’s emphasis on “the engaging of all parts” will lead to higher-quality, less-complicated trial protocols.
Still, some sites currently seem to be unaware of the more important changes in ICH E6(R3) and the need to modify, remove or add site processes to reach alignment with the guidelines, MacDonald said. One site reported that they “really don’t foresee any impact at all. It seems to me that they are changing the wording without changing any content.”
“We noticed that the sites tend to be more cautious about the potential impact. Some feedback suggests that they may already consider their processes as consistent with the (R3) guidance,” she said. “They just might not know what they don’t know yet.”
AQC plans to release a full report on survey findings by June. Learn more here.
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