ABS: Mariani, Content and quality of currently published phase II cancer trials

[Gretchen Whitney]

PT J
AU Mariani, L
 Ist Nazl Tumori, Dept Biometry, Via Venezian 1, I-20133 Milan, Italy.

   Marubini, E
TI Content and quality of currently published phase II cancer
   trials
SO JOURNAL OF CLINICAL ONCOLOGY
LA English
NR 30
SN 0732-183X
PU W B SAUNDERS CO
C1 Ist Nazl Tumori, Dept Biometry, Via Venezian 1, I-20133 Milan,
   Italy.
   Ist Nazl Tumori, Dept Biometry, I-20133 Milan, Italy.
   Univ Milan, Inst Med Stat & Biometry, Milan, Italy.
ID CLINICAL-TRIALS; MULTIPLE OUTCOMES; DESIGNS; 2-STAGE;
   GUIDELINES; TOXICITY; EFFICACY; THERAPY
AB Purpose: A number of statistical methods have been proposed for
   the design and analysis of phase II studies based on
   dichotomous outcomes. To investigate to what extent such
methods are in current use, we conducted a survey of published
   studies.

Materials and Methods: We identified studies by
   conducting a computerized literature search of MEDLINE. We
   considered trials on systemic antineoplastic treatments
   described as phase II or pilot. The search was limited to
   articles written in English and published in 1997.

Results:
   Three hundred eight trials were identified. The majority, ie,
   295 (95.8%), had been conducted as single-arm studies, with
   objective tumor response as the primary efficacy end point. An
   identifiable statistical design was reported for only 58
   (19.7%) of these trials. The quality in reporting the
   statistical design and compliance with the design in carrying
   out the study or results interpretation were frequently poor.
   The frequency of reporting the statistical design was not shown
   to increase over the years of study start and was not
   associated with sample size or study duration, Instead, a
   significant association was found with trial results (which
   were less frequently positive among studies with a statistical
   design) and with the impact factor of the publishing journal.

Conclusion: This survey shows that the quality of the
   statistical component of published phase II cancer trials is
   generally poor and raises suspicion that low quality is likely
   to bias study findings. Journals might improve the
   methodiologic standard of published articles through a more
   vigilant reviewing policy, (C) 2000 by American Society of
   Clinical Oncology.
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TC 0
BP 429
EP 436
PG 8
JI J. Clin. Oncol.
PY 2000
PD JAN
VL 18
IS 2
GA 275TK
PI PHILADELPHIA
RP Mariani L
  Ist Nazl Tumori, Dept Biometry, Via Venezian 1, I-20133 Milan, Italy.
J9 J CLIN ONCOL
PA INDEPENDENCE SQUARE WEST CURTIS CENTER, STE 300, PHILADELPHIA,
   PA 19106-3399 USA
UT ISI:000084836100025
ER

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