Ethical and Practical Problems With Double-Blind Control Studies

Placebos are a staple of double-blind, randomized control studies. This is because they help to reduce study bias. When treating malignant hematologic and oncologic disease, however, there are ethical and practical problems that arise.

 

From a practical perspective, it’s often easy to know who is receiving treatment and who is not. On the other hand, from an ethical perspective, “treating” such a serious illness with a placebo is problematic. So active control is a preferred method of treatment during testing. Even when receiving active control, control patients with complications might receive unnecessary treatments thanks to the double-blind nature of the study.

 

Any invasive methods for placebo administration must be justified. Patients should be unblinded if their disease recurs or progresses. Patients should likewise be unblinded when the experimental treatment causes substantial complications. Sponsors should present plans for blinding in both the protocol and statistical analysis plan. Informed consent must be given where sponsors plan to maintain study blindness. What’s more, the sponsor must justify the additional risk to the patient.

 

In our next blog, the final entry in this series, we will discuss new FDA guidelines regarding the inclusion of adolescent patients in studies.

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