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7/3/2002

PhRMA Clinical Trial Guidelines Tackle Authorship Issues

Kate Traynor

New ethics guidelines from the Pharmaceutical Research and Manufacturers of America (PhRMA) acknowledge the role of contract writers in preparing manuscripts and call for such ghostwriters to be recognized in publications.

The voluntary guidelines, "PhRMA Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results," (PDF) state that drug companies sometimes pay people "to help analyze and interpret data, and to produce manuscripts and presentations."

According to the guidelines, which go into effect in October, contract staff must work "in conjunction with the investigator-author." All authors, contract and otherwise, are to be given copies of "relevant statistical tables, figures, and reports needed to support the planned publication."

PhRMA suggests that paid writers or contributors be named as authors or recognized in the publication's acknowledgment section, depending on the person's level of contribution to the publication. To be considered an author, a contributor should play a "substantial" role in the study's design, the gathering and interpreting of data, or the writing, revising, or final approval of the manuscript.

The guidelines declare that the sponsor of a clinical trial owns the study data and has the right to decide who has access to it. Clinical trial sponsors that adhere to the guidelines must summarize the study's results and make them available to the investigators who conduct the trial. The guidelines also require the sponsors of multicenter studies to make available to participating investigators data summaries and reports from other sites involved in the trial.

Under the guidelines, trial sponsors have the right to review before publication any manuscripts, presentations, or abstracts related to the study. The guidelines declare that trial sponsors may not "suppress or veto" the publication of materials related to the study. But sponsors are allowed to delay for an unspecified "short time" publications that interfere with the sponsor's intellectual property rights.

The guidelines call for the publication of "meaningful" positive and negative findings from studies of "marketed products or investigational products that are approved for marketing." But the results of all postmarketing or preliminary studies need not be published. Specifically, the guidelines state that "[s]ponsors do not commit to publish the results of every exploratory study performed, or to make the designs of clinical trial protocols available publicly at inception."

On request, sponsors of clinical trials will provide to a medical journal reviewing a manuscript for possible publication a synopsis of the study protocol and the planned methods of data analysis. The guidelines call for the journal's personnel to treat the information as confidential.

In a background statement at PhRMA's Web site, the trade organization said that the guidelines were created to put into a single document "long-established practices for conducting clinical trials." Other issues discussed in the guidelines include:

  • Clinical researchers are encouraged to disclose to study participants any payment received by the investigator or the clinical site for conducting the study. The investigator or that person's family members should not have a "direct ownership interest" in the drug being studied. Clinical researchers and their institutions should not receive company stock or stock options as compensation for conducting the trial.  
  • A trial's safety monitoring committee should not include clinical investigators who are conducting the study that is being monitored. Voting members of the safety monitoring committee should neither have significant financial ties to the trial's sponsor nor be employed by the sponsor.  
  • Clinical trials conducted in the developing world are to be held to the same ethical standards as trials conducted in industrialized countries.