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Human Factors are a Risk in Randomized Control Trials

Posted on October 7th, 2016 by in Pharma R&D


The World Drug Safety Congress took place this month in Munich, and I was very happy to contribute to a panel discussion regarding human factors in drug safety. September is a time of celebration in Munich, and it was interesting to re-visit the Ludwig Maximillian University, the location of my post-doctoral work. It is 25 years since I left and joined the industry to work in the area of migraines.

My understanding of the role of human factors in R&D has changed over this time. More recently, as a business leader, my interest has been their role in the implementation of changing how processes operate across internal / external partnerships. As a migraine research leader, it was the impact of human factors in changes in placebo rates in clinical trials. I remember a comparison dose ranging study that had an 8 to 1 chance of the patient receiving an active agent that reported much higher than expected placebo rates. Perhaps the role of individual expectation may be involved in the change in response rate?

Human factors operate across all aspects of the R&D process, and, as we discussed on the panel, allow the management of risk in a variety of settings where people are involved. The panel discussed a range of initiatives, from lowering prescription errors to adherence to medications and medication management. However, there was one topic that was discussed which, with a little reflection, seems to be a potential key risk to how we create evidence for our innovations.

There were several comments about the effect of social media in drug safety. Patients are now using social media to ask questions about their medications and perhaps even report their experiences. This becomes another information pathway that will require suitable management for both clinical trials and the monitoring of registered products. The IMI initiative WEB-RADR1 has been running for two years with a focus on improving pharmacovigilance with new technology.

The impact of social media could develop into a significant issue. Apparently there is evidence that some patients in clinical trials are using social media to share information to try and figure out if they are on placebo or active treatment. The very human feature of seeking information to remove uncertainty may be a critical risk to the conduct of the trial, and potentially introduce significant variation across centers or communities. In my experience, a change in mental model or mindsets of participants might make a difference to a range of measures.

I would imagine the impact of these risks will be different across disease target and agent. However, there is certainly a potential hazard for maintaining the integrity of the clinical trial. Study sponsors may do well to create a risk management plan for ensuring the safety of the trial conduct. This creates another useful question as to how will the sponsor assess the integrity in the first place?

Social media has certainly made an impact on how we shop and share information over the last 10 years.  Perhaps the industry now needs to understand and manage how it could impact the already highly complex world of clinical trial design and implementation. A human factor risk analysis is focused on safety, whether it be using devices or operating complex engineering processes. The industry has a keen focus on management of clinical and commercial risks and it could be time to extend this human factor approach to the usability and application of clinical trials.


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All opinions shared in this post are the author’s own.

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