Patient and public involvement in clinical trials has been defined as “experimenting with” as opposed to “experimenting on” patients.1 It is founded on the belief that a collaborative approach to testing treatments is vital if the uncertainties that matter most to patients are to be reduced.2 In 1994, the ethicist Raanon Gillon proposed that not only morality but also scientific interest should combine to urge a “brave new partnership between clinical trialists and patients.”3

It is difficult to be precise about the origin of patient and public involvement but several early examples exist. Rose Kushner—a pioneer of patient involvement in the United States in the 1970s—was a freelance writer who also had breast cancer. She wrote a book, which was based on a thorough review of evidence of the effects of radical mastectomy. Her influence and attitude was such that she eventually reviewed new research proposals for the US National Cancer Institute.4 …