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Publication of Full Reports of Clinical Trials

University of Utah School of Medicine, Salt Lake City, UT

To the Editor: I commend the American Society of Clinical Oncology (ASCO) for formulating a revised conflict of interest policy (published online on April 29, 2003). It is notable that the policy primarily addresses financial conflicts of interest, but implicitly expresses concern about underreporting of trial results when it cautions investigators about contractual arrangements that grant sponsors veto power over publication decisions. This is relevant, but it is also known that the main cause of publication bias is the failure of investigators to publish results.¹

The underreporting of trial results is scientific misconduct, and has, once again, become the subject of recent commentary.² Along with research ethics committees³ and funders of research, professional organizations like ASCO can act to promote the public dissemination of trial results. Like many subspeciality societies, ASCO holds an annual meeting at which the results of trials are presented in abstract form. As with other societies, the full results of completed trials are often not subsequently reported.⁴ Abstracts are not a substitute for complete reporting of the rationale, design, and results of trials — physician-interpreters of trials and those conducting research synthesis (systematic reviews or meta-analyses) need complete reports. Reports are also needed for trials that are prematurely or unexpectedly terminated, or abandoned. I suggest ASCO adopt the following policies to ensure the complete reporting of trials presented in abstract form: (1) Trial registration. The case for trial registration has been summarized by Tonks.⁵ An application for abstract presentation should be accompanied by evidence of trial registration. This should apply to all trials — phase I through phase III. ASCO should promote registration at centralized registers (ClinicalTrials.gov and Current Controlled Trials Web sites) to discourage the proliferation of a multiplicity of smaller registers. Randomized controlled trials should be associated with an International Standard Randomized Controlled Trial Number.⁶ (2) Follow-up of trial reporting. The investigator presenting the abstract should assume responsibility for notifying ASCO of the subsequent complete reporting of the trial’s results. The location of the report should be identified in an updated description of the abstract on the Society’s Web site. Acceptable venues for public dissemination include print or online journals, trial banks, or other medically related Internet sites, hyperlinked to the Society’s electronic abstract archive. (3) Failure to report results in full. If a satisfactory reason for failure to report final and complete results after, perhaps, 2 years of completion of the trial, is not provided, an application from any of the coauthors to present an abstract at a subsequent meeting, or publish in an ASCO publication, should be denied until the situation is rectified.

I respectfully challenge ASCO to adopt these policies and apply them to its annual meetings beginning in 2004. In formulating a revised conflict of interest policy, ASCO will set a standard of research conduct that other speciality societies will be compelled to consider. It should do the same with respect to publication ethics applicable to clinical research.

AUTHOR’S DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

The author indicated no potential conflicts of interest.

REFERENCES

1. Dickersin K: Reducing reporting biases, in Chalmers I, Milne I, Trohler U (eds): The James Lind Library. http://www.jameslindlibrary.org/reporting.html

2. Antes G, Chalmers I: Under-reporting of clinical trials is unethical. Lancet 361:978–979, 2003[CrossRef][Medline]

3. Mann H: Research ethics committees and public dissemination of clinical trial results. Lancet 360:406–408, 2002[CrossRef][Medline]

4. Schwartz L, Woloshin S, Baczek L: Media coverage of scientific meetings: Too much, too soon? JAMA 287:2859–2863, 2002[Abstract/Free Full Text]

5. Tonks A: Registering clinical trials. BMJ 319:1565–1568, 1999[Free Full Text]

6. International Standard Randomised Controlled Trial Number. Current Controlled Trials. http://www.controlled-trials.com/isrctn/isrctn_faqs.asp

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This Article Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Mann, H. Search for Related Content PubMed PubMed Citation Articles by Mann, H. Social Bookmarking                            What's this?