The importance of independent academic statistical analysis

The profession of medicine in every aspect—clinical, education, and research—has been inundated with profound influence from the pharmaceutical and medical device industries (DeAngelis and Fontanarosa, 2008). With industry-sponsored biomedical research, there are numerous examples of high-profile and widely publicized occurrences of data misrepresentation, inappropriate statistical analyses, and selective reporting of major trial results. In 2001, JAMA instituted policies in an effort to counteract such problems, and since then we have continued to strengthen these procedures (Fontanarosa and others, 2005). Unfortunately, critics continue to misunderstand, misconstrue, and misrepresent the details, intention, and application of these policies (Keiding, 2010; Rothman and Evans, 2005). To help ensure the integrity and veracity of data reported in research papers published in JAMA, authors must fulfill 2 requirements. First, for all research reports containing original data (regardless of funding source), at least one author must state that she or he “had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis” (http:// JAMA.ama-assn.org/misc/ifora.dtl). For industry-sponsored studies, this statement must be provided by an investigator who is not employed by any commercial funding source. This requirement is intended to ensure that a responsible academic author is aware of and has full access to “all” data collected as part of the investigation. This investigator vouches for the completeness of the data set, so that if issues or questions should arise about missing data or incomplete reporting of data, this academic author will be held accountable and responsible. Second, industry-sponsored studies in which the data analysis has been conducted only by statisticians employed by the company sponsoring the research or by other for-profit entities will not be accepted for publication in JAMA. For these studies, an independent analysis must be conducted by a biostatistician who has a faculty appointment at, and is operating under the auspices of, an academic institution or who is employed by a government research institute. For these analyses, the entire raw data set must be provided to the independent biostatistician, along with the study protocol and the prespecified statistical analysis plan. The independent biostatistician verifies the appropriateness of the analytic plan and conducts an independent analysis of the raw data. The results of these analyses are reported in the manuscript. Details of this independent statistical analysis, as well as the name and academic institution of the independent statistician and whether compensation or funding was received for conducting the analyses, are also included in the published article. This requirement is not intended to cast aspersions toward biostatisticians employed by industry or to imply any doubt about their analytic capabilities. However, there may be unique considerations for employees of for-profit study sponsors because of the vested financial interest those companies have in