I recently read the following posts by two groups of research physicians. These investigators call CROs-- Contract Research Agonization and for good cause. We have all lost sight of what data are important in a clinical trial.
I applaud their impassioned plea: “It is time to start questioning the necessity of some aspects of the clinical trials data-collection process, particularly those that cause daily hassles before, during, and after a clinical trial – sometimes years after publication”.
The FDA, EMA, and ICH have told us, for over 5 years, as part of their Guidance documents on Risked Based Monitoring (RBM) and GCP, that the clinical research industry’s definition of quality (i.e., all check boxes are checked, every form “SDV’ed, and every query is answered) is not adequate trial oversight. The Regulators implored our industry to focus on critical data and employ rapid central review to identify and correct errors quickly to enhance study conduct and subject safety.
The challenge for the Clinical Research industry is to understand what data are important and what do the errors we identify tell us? Quality methods are based on investigating why errors occurred, not just that they did. You must first understand why the errors occurred to help you provide the best solution to correct them.
Some of the Burning Questions you should ask are as follows:
- Do the data make sense?
- Do we see signals we need to investigate (e.g., What do the deviations tell us?)? The actual number of deviations is not as important as the qualitative data on what the deviations are and how they are distributed across sites and users.
- What were the query topics?
- Did queries indicate an issue with the design of the data collector, training, or an error in generating a query?
- Should we query an issue not important in data analysis just because we can?
Deciding what not to do can be a very scary proposition for Sponsors and CROs. Clinical development teams must become involved to help Clinical Operations identify the really important areas to monitor in the clinical trial and what categories of non-critical data are OK to monitor less frequently or not at all. Clearly, assuring all aspects of primary efficacy and safety assessments are paramount.
Sponsors always want to know how to save money in trials: Here’s a simple way that they often don’t want to hear: identify what you don’t need to do
. You will free time for the sites to focus on what is important and save money.
To enhance your relationship with your sites, design straightforward trials focusing on what is important. Do not make busy work for the sites based on the historical mantra, “We’ve always done it this way.”.
We did a pivotal Phase III RBM trial with a tiny staff and a Sponsor that knew exactly what she wanted and how to support and focus our efforts. She had done many trials with traditional CROs that had frequent onsite visits—but they still missed important endpoint reviews and an entire site was lost due to errors in the ratings, her primary endpoint. Our study was done for a fraction of the traditional, expected cost because we used tools to enable immediate data review with a laser focus on what was important. 80% of the sites said they would use our paperless approach again—I think that says it all.
Want to get started on RBM and implementing the new GCP guidance? Join our free webinar on conducting a Risk Assessment—that’s the first step! https://attendee.gotowebinar.com/register/7140655505300708099