The revisions are proposed in response to an open letter to the EMA and ICH from February 2016, in which several stakeholders expressed concerns that the current E6 guideline failed to "sufficiently recognize variations in the level of risk for participants in different types of trials and allow corresponding flexibility in managing the risks."
The letter also detailed a "major concern" related to E6’s limited scope: "It was felt that a guideline entitled 'good clinical practice' should more holistically address the planning and conduct of clinical trials," according to the reflection paper.
The ICH said the goal of the potential renovations outlined in the reflection paper “is to provide updated guidance that is both appropriate and flexible enough to address the increasing diversity of study types and data sources that are being employed to support regulatory and other health policy decisions.”
Stakeholders can submit comments before March 11, 2017, at which time ICH will review feedback and determine whether to revise the currently proposed approach.
The organization said seeking comment on the paper is a “first step” in enhancing the ICH process “with respect to public consultation” on the revision of ICH E8 and E6.
ICH E6 (R2) and CRO oversight
ICH endorsed the development of ICH E6 (R2) in 2014 with the goal of providing improved patient protection with the advent of increasingly complex, multinational trials.
ICH E6 (R2) reached step 4 of the ICH process in November of last year – and as Rick Morrison, CEO of Comprehend, told us, is putting the spotlight on sponsors and their oversight processes.
“With an upcoming change in the rules regarding risk management, these organizations will be accountable for risk across all their CRO partners involved in study milestones,” Morrison explained. “This will drive sponsors to address risk management as a predictive and proactive effort, rather than (as they have in the past) as a reactive process.”
In order to achieve this, Morrison said sponsors need to engage their CROs in the effort to come up with joint plans, metrics, and evaluations to avoid strategic, operational, quality, and compliance risks.
“Best practices in the form of an Oversight Plan and Quality Agreement serve as the foundation for a compliant CRO oversight initiative, designed to improve the quality and timeliness of studies, but also to help address and adhere to important regulations such as ICH E6 (R2),” he added.
“Key to a successful working relationship in all industries is communication and collaboration. So it is no surprise this is particularly important in an outsourced model.”