A better type of clinical trial?

In a clinical trial, no one likes to be given the placebo. Research has shown again and again that many people who participate in clinical trials for new drugs, medical devices or procedures incorrectly assume that the aim of the study is to help the volunteers get better, a fallacy often called the “therapeutic misconception.”

Now a new type of study, called an adaptive trial, aims to remedy this problem by increasing the percentage of people who receive a superior treatment during a trial.

The traditional approach to dealing with the therapeutic misconception has been to make clear to participants, both verbally and in writing, that there is no guarantee of benefit from the study and that they will be randomly assigned to a group. This is done through a process called informed consent.

But in a commentary published today in the Journal of the American Medical Assn., researchers from the University of Michigan, UCLA and the University of Texas MD Anderson Cancer Center say that, in many cases, there may be a better approach.

They propose the use of adaptive trials, which change enrollment and treatment procedures as the study gathers information about the treatment. For example, if a study seeks to test a new heart disease drug against a placebo treatment and the drug appears to be working, later subjects will be more likely to receive it.

The authors argue that this type of change could make people more likely to participate in a clinical trial. “Many potential research participants are uncomfortable with random chance determining their treatment, and most would prefer to receive either the new treatment or to have an expert decide what is best for them,” they said.

While adaptive trials may seem great to people considering enrolling, their scientific value is not as clear. In a second commentary, a group of researchers from the University Medical Center Utrecht in the Netherlands write that adaptive trials may present fewer social and scientific benefits than traditional designs. They point out that the use of adaptive trials could make it difficult to keep scientists blind to which subjects are in which treatment group, a crucial part of any clinical study. Additionally, the authors worry that adaptive trials can sometime be unfair, as people who enroll in the trial later benefit more than people who join in the beginning.

“Researchers who conduct adaptive trials should be aware of these issues to ensure that the value of adaptive trials is not diminished, that the scientific validity of these trials is maintained, that unfair selection of trial participants does not occur, that burdens to participants do not increase, that trial protocol amendments are kept to the minimum, and that genuine informed consent is obtained,” they conclude.

You can read the commentaries online here and here.

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