title: State of the art in comparative cancer clinical trials.
abstract: In order to investigate the current state of the art in clinical cancer research, a survey of comparative cancer clinical trials was conducted using a MEDLINE literature search of the 6-month interval from July to December of 1985. Data were obtained primarily from the published abstracts. The major observations from the study are as follows. First, trials in cancer research are published in an extraordinarily wide range of journals covering most of the major medical specialties in addition to the many cancer specialty journals. Second, randomization is now used quite extensively. It is the predominant method of control in chemotherapy trials and in trials reported in cancer journals. However, its use is much less common in other specialties, especially surgery, so efforts to popularize randomization in these specialties would be beneficial. Third, sample sizes are highly variable, and the median sample size (96 patients) is too small to reliably detect and evaluate moderate treatment advances. Finally, our survey reveals that published trials show an inordinately large proportion of breakthroughs in treatment compared with the generally accepted view that only slow progress is being made in developing effective cancer treatments. Our view is that this result reflects the strong tendency to publish only studies with positive results. This hypothesis is supported by the fact that in nonrandom trials there tend to be more positive conclusions and an absence of a strong association between conclusions and sample size.
authors.affiliation: Division of Biostatistics, Dana-Farber Cancer Institute, Boston, MA 02115.
authors.forename: C B
authors.initials: CB
authors.lastname: Begg
authors.forename: S J
authors.initials: SJ
authors.lastname: Pocock
authors.forename: L
authors.initials: L
authors.lastname: Freedman
authors.forename: M
authors.initials: M
authors.lastname: Zelen
mesh_terms: D002986:Clinical Trials as Topic; D006801:Humans; D008523:MEDLARS; D009369:Neoplasms / Q000628:therapy*; D011897:Random Allocation; D013223:Statistics as Topic; D014481:United States