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Why is randomization in clinical trials important?


I am no stranger to the importance of randomization when conducting a study. I minored in psychology as an undergraduate, so I took part in the experimentation process--both by being experimented on and running an experiment. And the process of running experiments, holding trials and conducting studies was repeated until well known, and I was even tested on it. I also had to conduct my own studies and experiments in graduate school. Even if I was just conducting a content analysis (a fairly basic research technique used to examine texts), I would still need randomization.So why am I giving you my research background? Because I've never thought about the research process without randomization. Because I've never thought about what randomization might mean to the average person. And because I read a thought-provoking obit in The New York Times about the man who helped institute randomization in clinical trials in our country. Paul Meier, who died Aug. 7 from complications related to a stroke, essentially revolutionized the way we run clinical trials. Before Meier, researchers would test a new drug or treatment on patients they thought would have the greatest benefit, and then they would compare the data to other patients who didn't receive the treatment. Now what's wrong with this you say? It seems like people who need the treatment are receiving it. But the problem with this setup is bias. The people receiving the treatment could be stronger, healthier than those not receiving the treatment. Or there could be more people from one ethnicity, gender or age than another. Therefore, the results couldn't be generalized to a larger population because you wouldn't really know who gets the most benefit. Randomization ensures that both samples, those receiving treatment and those who aren't, are similar. Not only does this mean that the researcher can then translate the results to a larger population, but the math and the science behind the study are stronger. Meaning you get better results.And Meier was the person who insisted on this process in the U.S. Today, the Food and Drug Administration requires randomized trials be conducted before they'll approve a drug. And young researchers like me learn about randomization as part of the scientific process. And while this might seem inconsequential or it causes delays in getting treatments to patients, it's better for patients in the long run because it means safer and more effective treatments that are right for them.

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