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Understanding Clinical Trials

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Education before Participation: What is a control or control group?

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A control is the standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo.

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ghoshnamita123

Education before participation in clinical trial is very important.

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wmay13241

In a Phase 3 trial, the control group is given a placebo (sugar pill). The patient does not know if he/she is put in the control group. If a cancer patient is really sick and is unknowingly placed in the control group, there is a good chance that patient will progress and die. For this reason, my wife has refused to be in a Phase 3 clinical trial. Would you want to be that control group patient?

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FMundo in reply towmay13241

This is a rational decision. Some people don't want to play "Russian Roulette" with their lives, and I can't say I blame them. Unfortunately without a "control" (no therapy) it's not possible to ascertain whether a drug is improving the situation. The fact is, surveys show that most people join in Clinical trials for selfish rather than altruistic reasons. . . they want to get access to a drug that they can not otherwise have access to (for financial reasons, its not available on the market, they can't get their physician to prescribe it for them).

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wmay13241 in reply towmay13241

I should have pointed out that my wife participated in a Phase 2 Ibrutinib trial (no progression for 12 months) and a Phase 1 CAR-T trial (complete remission for 17 months and counting).

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