Thank you to all who registered and attended CluePoints’ recent webinar with Paragon Solutions: The Secrets of Successful Risk-Based Monitoring Revealed. We hope that you found the webinar informative. Below you will find the poll results and the documented Q&As. The on-demand recording can be viewed here. Enjoy!
The Poll Results
1: How aware is your company of the Risk-Based Monitoring approach to study management?
We are actively planning to implement an RBM strategy
We have announced our plans to move to RBM strategy
We have implemented RBM strategy
We have not assessed RBM approach yet
What is RBM?
2: How many clinical systems are used to manage studies and data today?
3: When you send out communications across your enterprise, what term do you use to describe this approach?
custom coined term
Quality by Design (QBD)
4: How many KRIs have you defined as standard/core for your enterprise?
5 or less
We have not defined any standard/core KRIs
1: Any data related to studies inspected by USFDA which had Risk-Based Monitoring approach against the traditional monitoring approach?
While there is no public domain data available on the success or failure of submitting an RBM study to the FDA – there is good data on the challenges in the existing model:
- About 50% of sites fail to reach the planned recruitment targets.*
- The majority if not all milestones missed in the clinical trials—more than 95% of clinical trials do not end on time and on budget as planned in the first place.*
- 90% of the studies meet their recruitment goals, but at the expense of mostly twice as much time as originally planned.* The costs attributable to these delays are gigantic.
- Too many avoidable protocol amendments, with a first amendment implemented even before the very first patient has been enrolled—most of them due to the rush towards “First-Patient-In”.
In addition, an analysis published by TransCelerate in 2014 (Steve Young was a co-author) revealed that – on average – only 1% of site-entered eCRF data gets corrected by the traditional approach of 100% on-site Source Data Verification and Review.**
* Tufts Center for the Study of Drug Development Impact Report “New Research from Tufts Characterizes Effectiveness and Variability of Patient Recruitment and Retention Practices”. 15 (1), January/February 2013.
** Therapeutic Innovation and Regulatory Science “Evaluating Source Data Verification as a Quality Control Measure in Clinical Trials”. November, 2014
2: If you were to use a single term that incorporates QBD and RBM but not use those in particular what do you suggest?
We like the ICH term of Quality Risk Management (QRM) – it is a broader term that encompasses the larger paradigm shift that is needed for this transition.
3: What do you think on implementing RBM in ClinPharm studies? Have companies implemented it in CP studies? (i do not mean FIH studies)
We strongly believe that the QBD and RBM approach should apply to any and all clinical research, including ClinPharm studies. In particular, the approach of identifying and mitigating risk through study design, study planning and execution is simply the appropriate way to approach clinical research. However, some of the operational details will look different depending on the study type. For example, some of the more intensive statistical monitoring methods may not apply to studies of very short duration or with very few sites. Similarly, the level of on-site monitoring and SDV/SDR will likely vary by study.