The hidden alternative: getting investigational treatments off-study.

Abstract

Research studies commonly randomise patients between standard care and some new form of treatment. In a substantial number of studies, the new treatment could have been obtained by the patient directly from their doctor, without participating in a study. Yet it is a common practice, endorsed and encouraged by the US government, not to advise potential research participants about their ability to get the new treatment outside of the study. This policy is even occurring in one of the largest studies ever funded by the US government, the 22000 patient, 5-year comparison of tamoxifen and raloxifene in the prevention of breast cancer. This practice has the effect of encouraging more individuals to participate in research studies, but the result is that their consent to participate is not fully voluntary. Many ongoing studies may therefore be of questionable ethical soundness.