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Clinical Trial Analogy for Real-World US Airways Flight Scenario

 

This is a second follow-up to my recent blog post on what happened flying back from the Osteoarthritis Imaging Conference. Aside from a variety of clarifying questions, I've found that the topic has consistently turned to one regarding compensation and specifically: "Did the airline give you a free flight in return for saving them a huge expense?"

Upfront disclaimer: US Airways did give me compensation: A $350 coupon for US Airways travel for me and since my wife was flying on a frequent flyer ticket, they gave me back 25,000 air miles. The ticket for my wife was in excess of 100,000 air miles. Was this fair compensation? I was underwhelmed, but I would value other opinions.

Their rationale was interesting. They claimed that this was as much as they could give. So while my ticket was paid for by BioClinica (and yes we travel economy) and I was traveling on business, I felt justified in keeping the coupon since it was my personal time that was inconvenienced. I did not get any work completed on the flight, nor did I get any sleep, so it took me a couple of days to catch up on everything at the expense of additional personal time.

So how does my scenario possibly relate to the world of clinical trials?

I was struck by the clinical trial analogy of what I deemed "fair" for this situation and to that of compensation for patients who suffer adverse reactions to drugs or have to undergo revisionary surgery following a faulty device implant. While the potential difference is obviously a magnitude or two greater, the analogy is similar – the flight got me to where I was going (on time), but not in the manner I expected. Within the pharma industry a product may provide the symptom relief or cure but often with other unrequired effects. Again, what is fair and acceptable is dependent on the severity of the effects and our personal expectations from life. The latter is greatly dependent on upbringing and our country of origin and current location.

How we as an industry handle the results of the complications of clinical trials, both mild and severe, has a direct consequence on our future ability to engage patients for new trials. My initial feeling of satisfaction for getting involved has been somewhat soured. I doubt I would be as quick to offer such help again, although if my wife and I had not stepped in we would have been delayed and the inconvenience even greater. And now I've told the world. Patients are no different. Side effects and adverse events will be a part of the clinical trial process as long as our understanding of the human body remains imperfect. So how fairly do we treat clinical trial subjects? Are we burning our bridges, or building them?

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