Control in a Clinical Trial

The gold standard for a clinical trial design is the inclusion of a control. A control could be a placebo, active or no treatment. Clinicians use controls in order to give more power for their studies. A placebo control is a vehicle without the active ingredient. The main purpose of using a placebo in clinical trials is to differentiate the background noise from the actual effect of the treatment drug. Regulatory agencies prefer or favor trials that use controls such as placebo since the data obtained will be clear and non-ambiguous [‎1].

The use of placebo controlled study has been controversial since it was first introduced (c 1931). In this study, distilled water was used as a control when Sanocrysin was tested as a possible treatment for tuberculosis. The use of placebo control in clinical trials becomes controversial when there are other effective treatments available. It is undeniable that the use of placebo control can be beneficial in giving a strong clinically relevant data [‎2].

The recent version of the declaration of Helsinki states that “the benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best current proven intervention, except in the following circumstances [‎3]:

• The use of placebo, or no treatment, is acceptable in studies where no current proven intervention exists; or

• Where for compelling and scientifically sound methodological reasons the use of placebo is necessary to determine the efficacy or safety of an intervention and the patients who receive placebo or no treatment will not be subject to any risk of serious or irreversible harm. Extreme care must be taken to avoid abuse of this option.”

Clinicians, however, have been justifying the use of plac...

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... in clinical trials. This decision will benefit pharmaceutical companies and CROs since it allows them to use placebo control even when a standard treatment is available [‎10 & ‎11].

As Epstein (2007) alluded that pharmaceutical companies could be exploiting the poor infrastructure, deferential patient population and the lack of regulatory body in developing countries to conduct clinical trials that are ethically unacceptable [‎12].

This paper, by no means, is suggesting to completely avoid a placebo controlled studies. However, it points out that special care and thoughtful considerations need to be taken when planning a placebo controlled study especially where there are existing treatments. In addition, when conducting clinical trials in developing countries, patients should be given equal rights and opportunities as their counterparts in the developed countries.