© 2005 Oxford University Press
CORRESPONDENCE |
RESPONSE: Re: Reporting Recommendations for Tumor Marker Prognostic Studies (REMARK)
Affiliations of authors: Biometric Research Branch (LMM), Cancer Diagnosis Program (SET), DCTD, National Cancer Institute, Bethesda, MD; Centre for Statistics in Medicine, Wolfson College, Oxford, U.K. (DGA); Institut fuer Medizinische Biometrie und Medizinische Informati, Universitaetsklinikum Freiburg, Freiburg, Germany (WS); Centro Regionale Indicatori Biochimici di Tumore, Ospedale Civile, Venezia, Italy (MG); OSI Pharmaceuticals, Inc., Boulder, CO (GMC)
Correspondence to: Lisa M. McShane, PhD, Biometric Research Branch, DCTD, National Cancer Institute, Room 8126, Executive Plaza North, 6130 Executive Blvd., Bethesda, MD 20892-7434 (e-mail: lm5h{at}nih.gov).
We thank Popat and Houlston for their expression of support of the principles underpinning the REMARK guidelines, and we welcome further dialogue on the specific topic of public access to raw time-to-event data. Popat and Houlston suggest that we "missed a major opportunity by falling short of mandating public access to raw time-to-event data." We mostly agree with Popat and Houlston on the idea of making raw data publicly accessible, as indicated by our statement "we view movement in this direction as generally positive." However, we would like to explain our reasons for not bundling data access issues with the REMARK guidelines.
We did not consider ourselves in a position to "mandate" anything—either public access to raw data or adherence to the REMARK guidelines. Our approach with the REMARK guidelines was to make recommendations that were based on sound arguments and empirical evidence supporting the notion that adherence to the guidelines would benefit tumor marker research. An explanatory document in preparation will explicitly detail these arguments and evidence. Journal editors, funding agencies, and review bodies can mandate adherence, but they would wisely do so only if the rationale and benefits are clear.
There are serious deficiencies in the quality of reporting of tumor marker studies. We maintain our position that "more is better" only when the data are of good quality. If studies are not clearly and fully reported, it may be impossible to distinguish badly designed or poorly executed studies from high-quality studies. Including data from poor studies in a meta-analysis might only add noise and obscure true findings. Even data from a high-quality study may be misinterpreted or misused if the details of the study design, execution, and analysis are not carefully documented. We believe that the problem of poor reporting of studies has to be tackled first, and we hope that the REMARK guidelines will lead to improvements.
How to best implement public access to data must be carefully considered. If all journals were to require full public access to data from studies they published, this activity would capture much, but not all, of the useful data. The problem of publication bias is well recognized. For example, in an article by Kyzas et al. (1) published recently in this Journal, there were striking differences in estimated association between TP53 status and mortality, depending on whether unpublished data were included in the meta-analysis. Perhaps investigators and their supporting institutions should bear some of the responsibility for making freely accessible the data produced by their studies, regardless of whether those studies are ultimately published. The nature and quality of the data produced could serve as one measure of accountability for the time and resources expended to conduct the research that would go beyond counting published papers.
To summarize—yes, let's work toward open access to tumor marker study data, but let's do it right.
REFERENCES
(1) Kyzas PA, Loizou KT, Ioannidis JPA. Selective reporting biases in cancer prognostic factor studies. J Natl Cancer Inst 2005;97:1043–55.
Related Correspondence
CiteULike 
Connotea 
Del.icio.us What's this?
J Natl Cancer Inst 2005 97: 1855.
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||