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Randomization
Last Updated: Aug 30, 2012
Originally posted by: Anonymous on the former AccrualNet site on May 18, 2010.
Does anyone have any suggestions as to how to respond when a patient objects to enrolling in a trial because they do not want to be randomized?
Originally posted by: Anonymous on the former AccrualNet site on May 20, 2010.
My guess is that any patient not enrolling in a study simply because they don’t want to be “randomized” is likely to be concerned with the trial for other reasons and just not communicating it. Concerns with a placebo arm (or the misunderstanding that they will at least receive standard of care), required visits, or that the investigational product is experimental may be some of those reasons.
Originally posted by: Anonymous on the former AccrualNet site on May 26, 2010.
Some people are concerned about randomization because they want the experimental agent and don\'t want to risk not getting it.
Suggestions:
1. Explain that per federal regulations, with randomized trials, experts have to be genuinely uncertain about which treatment is superior.
2. Explain that per federal regulations, all of the treatment arms have to be at least as good as standard of care.
3. If it’s an unapproved drug, they won’t have a chance of getting it without being on a study.
Originally posted by: kendra-f on the former AccrualNet site on Jul 14, 2011.
If a potential subject objects to randomization, I calmly explain the rationale behind it. If they are not satisfied with my answer (based on facts, rationale, etc.,) I simply give them the option to either join or not join the trial. They must be ok with the possibility of not getting the \"desired\" arm. If they are not ok with that possibility, they are often not an appropriate candidate for the trial. This type of patient may drop out of the study prematurely anyway due to dissatisfaction with the randomization assignment. I have had this happen in the past. If patients are consented properly and not pressured, they will be easier to work with and are more likely to stay the course in the trial.