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Thursday, June 28, 2018

Are Most Clinical Trials Unethical?

Michel Shamy
American Council on Science and Health
Originally published May 21, 2018

Here is an excerpt:

Therefore, to render RCTs scientifically and ethically justifiable, certain conditions must be met. But what are they?

Much of the recent literature on the topic of RCT ethics references the concept of “equipoise,” which refers to uncertainty or disagreement in the medical community. Though it is widely cited, “equipoise” has been defined inconsistently, is not universally accepted, and can be difficult to operationalize. Most scientists agree that we should not do another study when the answer is known ahead of time; to do so would be redundant, wasteful, and ultimately harmful to patients. When some estimates suggest that as much as 85% of clinical research may be wasteful, there is a strong imperative to develop clear criteria for when RCTs are necessary. In the absence of such criteria, RCTs that are unnecessary may be allowed to proceed – and unnecessary RCTs are, by definition, unethical.

We have proposed a preliminary set of criteria to guide judgments about whether a proposed RCT is scientifically justified. Every RCT should (1) ask a clear question, (2) assert a specific hypothesis, and (3) ensure that the hypothesis has not already been answered by available knowledge, including non-randomized studies. Then, we examined a sample of high quality, published RCTs and found that only 44% met these criteria.

The information is here.