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December 16, 1983

Serious flaws mar many cancer therapy trials

JAMA. 1983;250(23):3142-3143. doi:10.1001/jama.1983.03340230010004

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Poor patient selection, inadequate follow-up, and premature reporting of results are among the factors that may obfuscate the meaning of many clinical trials in cancer medicine, according to several participants in the Sixth Annual Bristol-Myers Symposium on Cancer Research, held this year in Venice.

For example, Umberto Veronesi, MD, director general of the Italian National Cancer Institute in Milan, pointed out that although 100 different trials on the use of chemotherapy or radiation therapy as an adjunct to cancer surgery were carried out in 1982 alone, the results in many were unconvincing or contradictory.

The main flaw in such trials is that they provide little information as to the best time to administer adjunctive therapy. "A correct design for a trial on the efficacy of adjunctive surgical node dissection and/or of postoperative radiotherapy or adjunctive chemotherapy must explore their differential efficacies when applied 'earlier' [when presumptive metastases may be occult]