Enrollment in Cancer Trials Not Linked to Better Health Outcomes

Issue 24 January 2004

The widely held view that people with cancer who participate in clinical trials have better treatment outcomes is disputed by US authors of a study in this week's issue of THE LANCET.

Less than 5% of adults with cancer are enrolled into clinical trials. Steven Joffe from the Dana-Farber Cancer Institute, Boston, USA, and colleagues reviewed 26 previously published studies that compared the health outcomes of cancer patients enrolled or not enrolled in clinical trials.

Although 14 of the studies suggested a beneficial health outcome for trial participants, most studies did not effectively control for bias. For example, only nine studies required the same entry criteria for participating and non-participating patients, and only three of these found that trial participants had better outcomes than non-participants.

Steven Joffe comments: "Until more convincing evidence for a trial effect is available, recruitment messages to patients considering trials should focus on their contribution to advances in treatment. We believe that patients, professionals, and third-party payers can recognise the crucial function of clinical trials in advancing treatment, and that de-emphasising direct benefits to patients need not compromise accrual or coverage. We remain optimistic that strong support for trials can flourish on the basis of their unquestioned role in improving options and outcomes for patients with cancer."

Please remember to cite THE LANCET.