CROs more than sponsors turning to QbD for clinical research, survey finds

08-May-2014 - Last updated on 09-May-2014 at 20:57 GMT

CROs (contract research organizations) are more likely than sponsors to report frequent application of QbD (quality by design) principles for clinical research, though neither group seems particularly comfortable with QbD yet, according to preliminary findings from industry group Avoca's survey.

The preliminary results of the survey – presented at Avoca’s Consortium in Princeton, NJ, last week, reveal that only half of respondents said they have at least a “good understanding” of QbD processes, as applied to clinical development, while only 30% said they’re establishing infrastructure for QbD methods for clinical research.

Stephen Cutler, group president of Icon, said he believes “there’s a fork in the road” in terms of progressing QbD, which represents “an opportunity to push this forward,” and to address issues “around regulation and the complexity of protocols.”

QbD methods were most likely to be applied to site monitoring, according to the survey, which was followed by clinical program planning, protocol design and data collection.

The greatest challenge to the adoption of QbD seems to be internal infrastructure, according to the survey, though 24% of respondents said they’re not implementing QbD yet.

Coleen Glessner, VP of clinical trial process and quality at Pfizer, said that although the company has instituted QbD for all protocols run with its two CROs – Icon and Parexel – the two major challenges are that “it’s become a burden” and that it’s “all about the tool – the piece that’s missing is in the thinking, which is where the paradigm shift needs to happen.”

“Stopping and thinking about what really matters is at the heart of QbD,” Jeffrey Kasher, VP of clinical innovation and implementation at Eli Lilly, noted. He added that Lilly focused its efforts on reducing protocol amendments within the first 100 days of a trial, which the company eliminated in Q4 of last year.

As far as advice on how companies can better deal with the challenges of implementing QbD, respondents said:

Make sure you’re assessing the suppliers and understanding their experience and expertise in adopting QbD;
Deploy best practices for conducting supplier risk assessments for outsourced services;
Joint collaboration with partners to ensure appropriate implementation of QbD; and
Build QbD methodologies into vendor contracts.