Evaluating Tolerability & Efficacy of Clinical Operations Processes

Posted by Paddy Wall on Dec 5, 2016 3:49:12 PM

Deming’s Red Bead Experiment sums up a lot of what we experience in clinical operations. Managers do their best to motivate site staff to do better when the system is neither efficient nor tolerable and the odds are stacked against any individual improvement.

Watch a short explanatory video below:


In summary, the red bead experiment involves workers performing tasks in a system where the outcome is beyond their control, yet most efforts at improvement are aimed at motivating the worker. All staff carry out the same process, but the resulting proportion of compliant vs non-compliant procedures is essentially a lucky dip. The result is a group of demotivated staff with lots of personnel from the quality department peering over their shoulder telling them that they were non-compliant. Sound familiar?

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We motivate staff in Clinical Research Centres to boost patient recruitment & patient retention, comply with the clinical trial protocol,
 and remain inspection ready. We motivate patients to take part in studies, stay involved throughout, and comply with the multitude of requirements that a modern protocol dictates. We do all this by providing the protocol in the same way, training the same way, and communicating the same way we have done for many years. How do we try to achieve better results? We motivate harder.

Very often, study visits - like the Red Bead Experiment - are a game of chance. No amount of motivation can account for the problems inherent in the process. Human error is not, but should be, expected as staff stumble upon all the opportunities for mistakes that have not been removed from the process. They are then reprimanded and told to improve performance.


“When people try to do what they can not do, they wish to give up.”

W. Edwards Deming


Is it really any wonder that 28% to 60% of sites recruit few if any patients? [1] If information is presented to sites in many different text-heavy document formats, how can we expect 100% protocol compliance? How reasonable is it to expect site staff in the clinical setting to be able to mine through multiple large documents to locate information crucial to compliance? Time & Events tables, for example, now often span four or more pages with the obligatory litany of footnotes in miniscule writing at the bottom of each one. Sure enough, since 2006, 55% of PIs in Europe, 53% in Asia Pacific, and 40% in North America have not conducted another clinical trial. [2]


“Best efforts will not substitute for knowledge.”

W. Edwards Deming


Should we be surprised that 46% of all investigator deficiencies in clinical trials are due to protocol non-compliance? [3] Remembering that clinical research is often not the core function for many sites, does it really make sense to spend over $200,000 to “train” only two members of each site’s team at an investigator meeting that occurs months in advance of that site seeing their first patient for the trial? Besides, investigator meeting training typically consists of ‘death by PowerPoint’ in a hotel setting that is simply not real world. Surely just-in-time instruction during a patient visit would be much more powerful?

Risk-Based Monitoring and Patient Centricity have become hot topics in recent years. Both remain highly relevant and are now mainstream practice in clinical research, but adoption of effective site and patient support processes and mechanisms have not kept pace in our clinical operations processes. It is important not to focus only on encouragement and monitoring of risky sites to reduce deviations and increase engagement. Give your sites the tools they need to remove the risk.

How tolerable and effective are your research processes?


“It is not enough to do your best; you must know what to do, and then do your best.”

W. Edwards Deming


Deming Clinical Trials.jpg


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[1]         "Clinical Trial Challenges". Covance

[2]         "Principle Investigator Turnover". PharmaVoice

[3]         Dr. Richard Moscicki, at Site Solution Summit 2015

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