Hillman and colleagues (1991) have raised an important issue concerning the potential bias in the conduct and reporting of economic analyses sponsored by pharmaceutical companies. Question 17 in Table 1 addresses this issue, as well as an assessment of the likely competence of the individuals who produce the report. Those reviewing economic documents would like to assure themselves that the potential for such bias has been avoided as much as possible.

It would be preferable to establish a contract between the investigators and the sponsoring pharmaceutical company that establishes the investigators' independence over methods and reporting of results, including the opportunities for publication. This will be possible in some cases, particularly where the analysis is being performed after the results of the clinical trials have been reported. In other cases, such as simultaneous performance of both a phase 3 trial and an economic study, pharmaceutical companies may be reluctant to give investigators more independence over the economic part of the study than is common practice for the clinical portion of the study. Of course, investigators can share the manuscript with the manufacturer prior to publication and receive non-binding feedback.

Question 17 does not prescribe a standard but rather asks questions about the independence of the relationship between those individuals who performed the analysis and the pharmaceutical company. Anyone, including individuals who are employees of the company, can produce an analysis for the submission. However, at a minimum, the supporting document should clearly state the authors of the analysis and the source of funding. Authors of these reports may wish to describe their funding contract in a manner similar to that of Krahn and Detsky (1993) and should sign a letter indicating they have read and agree with the document presented.

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