Listen to all the voices: an advocate's perspective on early access to investigational therapies

Abstract

In this issue of the journal, The Society for Clinical Trials, whose members are clinical investigators and regulators in academia, government and industry, has published the rationale for their opposition to US Senate bill S. 1956, the socalled “ACCESS” act, which would allow the marketing of therapies that have undergone only Phase I studies (dose finding and toxicity testing) in humans, to patients with “serious and life-threatening” disease who have exhausted other treatment options. While this bill reflects the views and efforts of some cancer advocates and their supporters, it does not represent the beliefs of the cancer advocacy community overall. The essay that follows is inspired by the need for other voices from the patient and advocacy communities to be heard in this debate.