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Strengthening the credibility of clinical research
Catherine D DeAngelis a, Phil B Fontanarosa a
is an important example of the continuing and increasing awareness of medical journal editors' commitments to fulfil their responsibility to physicians and patients to ensure that all articles published in their journals are accurate, valid, and honest. However, given the inappropriate conduct, selective data analysis and reporting, misrepresentation of study results, and attempts at manipulation that have occurred with some industry-sponsored studies, redoubling efforts to ensure integrity in medical research has never been more important.
We are not surprised to learn that The Lancet considers the results of its forward-thinking approach to protocol review to be “disappointing” and we share the hope that the forthcoming SPIRIT guidelines will help to improve the reporting of scientific and ethical issues involving clinical trials. However, we maintain that perhaps the most effective way to strengthen the credibility of industry-sponsored medical research is to do exactly what many for-profit research sponsors continue to resist—ie, take steps to minimise or eliminate the study sponsor's control over the collection, collation, analysis, and reporting of study data, and require that these responsibilities be conducted solely by independent academic researchers, with no sponsor involvement whatsoever.
The Lancet has already taken an important step in this direction, by requiring that “the corresponding author should confirm that he or she had full access to all of the data in the study and had final responsibility for the decision to submit for publication.”2 We encourage The Lancet editors and the editors of other medical journals to take the next logical and essential step—ie, to require, as a condition of publication, that all industry-sponsored studies have the data analysed by an independent academic biostatistician or researcher who has full access to all study data, and that the results of this analysis must be the results reported in the article.3 In the same manner as the International Committee of Medical Journal Editors' require that clinical trials must be registered to be considered for publication,4 if major journals would adopt the approach requiring that academic authors have full access to all study data and requiring an independent statistical analysis, the credibility of clinical research funded and conducted by industry is bound to be strengthened.
We declare that we have no conflicts of interest.
References
1 The Lancet. Strengthening the credibility of clinical research. Lancet 2010; 375: 1225. Full Text | PDF(74KB) | CrossRef | PubMed
2 The Lancet. Information for authors. http://download.thelancet.com/flatcontentassets/authors/lancet-information-for-authors.pdf. (accessed April 19, 2010).
3 DeAngelis CD, Fontanarosa PB. Ensuring integrity in industry sponsored research. Primum non nocere, revisited. JAMA 2010; 303: 1196-1198. CrossRef | PubMed
4 DeAngelis CD, Drazen JM, Frizelle FA, et al. Clinical trial registration. a statement from the International Committee of Medical Journal Editors. JAMA 2004; 292: 1363-1364. CrossRef | PubMed
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