Most Cancer Clinical Trials Go Unpublished

Findings from fewer than one in five registered cancer clinical trials are published in peer-reviewed journals, according to a study that appeared September 15 in The Oncologist. This finding, the authors state, raises the concern of publication bias in cancer clinical trials.

Drs. Scott Ramsey and John Scoggins of the Fred Hutchinson Cancer Research Center and the University of Washington found that between 1999 and 2007, only 17.6 percent of cancer-related trials registered with ClinicalTrials.gov (the federal registry for clinical trials of interventions for serious or life-threatening conditions) went on to be published in widely accessible journals listed in the PubMed.gov online database.

The researchers also found evidence of a selection bias on the part of investigators, who are less likely to publish results of a trial that did not meet its endpoints. Though more than 94 percent of the registered, industry-sponsored trials were never published, three-fourths of those in PubMed.gov reported positive results. By comparison, 59 percent of NCI-supported trials were published, half of which reported negative results.

In a related commentary, Dr. James H. Doroshow, director of NCI's Division of Cancer Treatment and Diagnosis, wrote that "the apparent lack of access to the final efficacy and toxicity data…poses multiple scientific and ethical questions." He described an NCI clinical trials database project expected to launch in 2009 that will address this problem by requiring administrative and outcome data for all intervention studies that receive NCI support.

The Oncologist is also considering creating a peer-reviewed, searchable venue for "well-executed trials that fail to meet positive endpoints," wrote Editor-in-Chief Dr. Bruce A. Chabner and Senior Editor Dr. Gregory A. Curt, for trials that are "'negative' in a sense, but valuable nonetheless."

National Cancer Institute Bulletin
September 23, 2008 • Volume 5 / Number 19

LET THE PATIENT BEWARE!!!!!!!!

Jimmy B