Thanks for posting, Catherine. This is huge, and will only get huger!
To summarize, the authors have observed that patients enrolled in trials increasingly share their experiences and test results with each other online, often through social media networks. In effect, they may even successfully, and intentionally, “un-blind” themselves in double-blind trials. Also, where patients in the past have sometimes been treated rather offhandly, not even given the results of the trial at the end but having to put up $30 to buy the medical journal it’s published in, patients are sharing this type of info, too, and having something to say about how they are treated.
Some groups of patients (the authors quote a trial of a drug for ALS) have shared and statistically analysed results so completely, using informed and novel methods, that they beat researchers to some of the real-world implications of the treatment. However, data sharing among laypeople can have its dangers as well, such as when a subset of patients and others misinterpret a bit of data and begin self-administering a harmful substance.
The authors point out that, rather than have phase III studies break down in mid-stream due to participants un-blinding themselves and their doctors, researchers must develop new protocols to engage patients, when they so desire, in co-operative information sharing and choice making. They posit that this may lead to more robust, real-world conclusions.
There is also the FDA involvement as they set data integrity standards that need to be met for approval of the drug. So treating the trial participants with respect is in everybody’s best interest and the right thing to boot.
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