“Any risk management plan is going to be important, but even more so now because we have the ICH E6 revision [from the International Council for Harmonization] that explicitly calls for quality management” in the conduct of clinical trials, notes Deborah Rosenbaum, a clinical research consultant and trainer with Sarrison Clinical Research, llc.
The ICH brings together regulatory authorities and pharmaceutical industry representatives from the U.S., Canada, Europe, Japan, and elsewhere to discuss scientific and technical aspects of drug registration in an effort to greater harmonize the conduct of clinical research and drug development worldwide. Among other guidelines produced by the ICH is the Guideline for Good Clinical Practice E6, recently updated to the ICH E6 (R2) version.
Even as ICH puts more pressure on clinical trial practitioners to get a firm grip on quality risk management, it does have its benefits, too. “It’s outlining the steps to risk management [instead of having everyone still do] it in a different manner; this is good because it will offer some consistency across contract research organizations, pharma, studies, protocols—kind of everything we do,” adds Melissa Nezos, executive director of clinical operations in the Americas with Chiltern International.
The demand could hit different shops in different ways, explains Caroline LaPlaca Davis, executive director of clinical operations with Arrowhead Pharmaceuticals, Inc. In her experience working with smaller companies and/or relatively new operations, she’s observed there has “not really been an integrated quality plan.”
Using the ICH E6 (R2) as a springboard, Rosenbaum, Nezos, and Davis will offer tips and tactics in a two-part “Master Series” session at the ACRP 2017 Meeting & Expo to build a quality risk management plan that handles risk identification, evaluation, control, communications, review, and reporting. View Program and Schedule
For some companies, an overarching approach is a new concept when it comes to confronting risk, Davis adds. In the past, she explains, many companies have approached the topic in many ways.
Some shops may be alarmed by what ICH E6(R2) delineates because they already thought they were handling quality risk management properly, Davis says. Fortunately, there are ways to address this effectively, she adds.
It’s not a one-size-fits-all approach, Nezos says. With that in mind, however, she recommends a specific approach that follows the TransCelerate BioPharma Inc. notion of an overarching integrated action plan for the entire study, including data management, clinical monitoring plan, and fiscal analysis plan.
“The intention is to bring those pieces together into one plan,” Rosenbaum adds. With the plan in place, the next goal is to evaluate and try to anticipate risks, she says.
Getting this done right is important on several levels. In addition to the obvious importance of conducting the safest possible clinical trials, it allows shops to “focus resources and time on activities that are directly related to things that matter,” Nezos says.
Author: Michael Causey