The biggest paradigm shift in decades? ICH E6 R2

By Melissa Fassbender contact

- Last updated on GMT

(Image: Getty/masterzphotois)
(Image: Getty/masterzphotois)

Related tags: ICH E6 R2, Risk-based monitoring, Data

ICH E6 R2 sparked a paradigm shift, though 2019 will see the clinical trials industry transition from a risk-based monitoring approach to risk-based quality management.

ICH E6 R2​ modernized the ICH Good Clinical Practice (GCP) Guideline​, which was implemented more than 20 years ago, and requires that sponsors and contract research organizations (CROs) adopt a risk-based approach to study execution.

To meet the guideline’s requirements, several companies developed – others purchased – new risk-based monitoring (RBM) technology to help mitigate risk in clinical trials.

Patrick Hughes, chief commercial officer, CluePoints, said the ratification of ICH E6 R2 “heralded the biggest paradigm shift in the industry in decades.”

Read: How to prepare for ICH E6 R2 implementation

As Hughes explained, the updated guideline ensures “that sponsors undertake risk assessment during pre-study start-up, implement risk controls and corrective action during study conduct, and keep a full, auditable log of everything that has been done, by who, when, and why.”

Now, the transition to risk-based quality management (RBQM) from risk-based monitoring (RBM) will be the biggest area of change seen during 2019, he said.

There also will be growth in the use of wearables in the new year, Hughes added, which will require an “unsupervised approach to interrogation of the data”​ as researchers collect “significantly more data points than a traditional clinical trial.”

However, while the industry’s use of RBQM is still in its infancy, Hughes said, “We firmly believe that the comprehensive and independent interrogation of all data using a statistically-driven approach will be a component of every clinical trial in the next three years.”

In the new year, Hughes hopes the industry will accelerate its adoption of ICH E6 R2 to ensure compliance with the new regulations.

“It will be interesting to see how the regulators respond to submissions that have not adopted a risk-based approach to study execution since any delays due to non-compliance will have a material effect on direct costs and opportunity costs of a lengthier approval process,”​ he added.

If well publicized, Hughes said these delays will cause a "sea change"​ in how the new RBQM approach is implemented, as any regulatory delays due to non-compliance will push industry-wide adoption.

Ultimately, Hughes said it is “inevitable” ​that global adoption of ICH E6 R2 will drive significant change in the industry. “It is rare that a change in regulations insists that sponsors become more efficient,”​ he explained, “but this is vital if sponsors are to continue to invest in their pipeline development.”

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