Clinical.Life.Sciences.Fran.Ross.2017.jpgParagon's Fran Ross shares her industry perspectives on clinical process quality. What are her thoughts on ICH E6 R2?  

After years of attending industry conferences, it was very positive to attend presentations at January TMF Summit where an impressive number of organizations discussed their TMF Metrics programs. We know from our engagements how even simple metrics, when supported by well-governed actions, effectively move the bar for GCP TMF inspection surety.

Unfortunately, I also heard many examples of the same old non-value GCP documentation practices:
  • Rejecting unsigned or “outdated ” CVs
  • Critically busy site staff rescanning skewed medical licenses
  • Delayed site activation due to insignificant typos

We know that millions are spent attempting to repair TMFs long after trial completion.  And far too many TMF actors are still mired in outdated, restrictive and unnecessary TMF/GCP Essential Document practices.  We have made it overly complex to comply with GCP and hindered the study actors from simple compliance documentation – and now clinical sites are leveraging faster and easier tools without full consideration of their GCP record requirements.

Those of us in the trenches know it’s been a long journey to overly -engineered GCP interpretations codified in infective SOPs:

  • CAPA programs apply solution for an old trial issue to active studies
  • That’s how it’s done mindset brought from one organization to another
  • The speed of and adoption churn from new clinical trial technologies
  • Negative inspection results driving SOPs that increase complexity and risk

Another way is at hand.  I believe the revision to ICH GCP E6 is a clarion call to drive attention to the trial risks that matter, and to ensure the resultant evidence of right -sized GCP compliance is filed in the TMF.  Overwrought GCP practices are in direct conflict with the intent of R2.

ICH GCP E6 R2, ratified on November 9, 2016, is a mandate for change.

Section 5 Quality Management states: The methods used to assure and control the quality of the trial should be proportionate to the risks inherent in the trial and the importance of the information collected. The sponsor should ensure that all aspects of the trial are operationally feasible and should avoid unnecessary complexity, procedures, and data collection.

Operationally feasible methods. Proportionate to critical trial risks. Avoid unnecessary complexity. 

Clinical.Life.Sciences.Fran.Ross.Paragon.2017.jpgWhat does it all mean? 

There is no simple, one -size -fits -all solution to the rapid expenditure of time and capital  in product development, and there is no quick fix. However, the thoughtfully governed application of Quality Risk Management practices can unburden the team to focus on what matters: subject safety, data accuracy and protocol adherence. At the time of a health authority inspection, all that counts is to demonstrate that GCP compliance was maintained throughout the clinical trial.

  • Do you have what it takes to turn your TMF from a content silo burden to a trial management enabler?

  • Do you have the vision to enable your organization to identify, take on and actively manage the risks?

Applying the principles of Quality Risk Management to GCP processes requires thoughtful reassessment and deep executive commitment. While Quality Risk Management is not a new practice, it is a dramatic perspective change.  Clinical studies are inherently unpredictable, therefore, our risk management approach needs to be flexible and adaptable to new situations as they arise.

Are you ready to take on the challenge of fully leveraging the promise of ICH GCP E6 R2 in running your clinical trials ? 

Can you leverage QRM to increase inspection surety in your TMFs? Will your organization succeed and thrive if you don’t? We want to hear your comments, so please share with us your thoughts in our Leave a Comment section below!