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October 15, 2009 (Vol. 29, No. 18)

Update on Evolving Regulatory Guidance

Companies Need to Be Cognizant of and Continually Adjust to Changing Guidelines

  • The FDA’s position on a myriad of issues is constantly evolving. Companies need to be aware of these pending and implemented changes and adjust their practices accordingly. This month’s column will focus on ghost writing of medical journal articles, personnel training, access to investigational drugs, foreign inspections, and cancer vaccines.

    Exposing industry ghost writing of articles for clinical investigators has been high on the agenda of Senator Charles Grassley, who has been asking major medical journals what their policies regarding such articles are. In fact, many sponsors of clinical studies, faced with the slowness of their clinical investigators to write up the data, have tried to expedite the process by organizing the clinical data tables and even writing the first draft. 

    Obviously, some larger pharmaceutical companies have taken this one step further and employed medical writers to completely ghost write clinical articles. Companies are now faced with a dilemma—how much assistance can they give clinical investigators to facilitate article preparation? 

    One solution currently being implemented is to put a separable, deliverable payment clause in the clinical site/investigator agreement that facilitates the timely preparation of a final manuscript ready for submission. Another option that several companies are pursuing is providing an acknowledgement in an article footnote stating what the company provided, for example, statistical and data charts and/or methods and materials section drafting. 

    Senator Grassley appears to be receptive to the idea of footnoted disclosure in the published article. It remains unclear how journal editors and reviewers feel about such practices, however.

  • GCP: Personnel Training

    In a recent warning letter, FDA made clear to both clinical investigators and sponsors that the level of good clinical practice experience in clinical coordinators needs to be explicitly demonstrated. The warning letter in question cited an inexperienced clinical investigator for his reliance on equally inexperienced clinical coordinators, all of whom lacked sufficient training. 

    This warning letter, and several others like it that were also recently sent, bring to the forefront the fundamental problem of sponsors not adequately conducting site-initiation visits and site-personnel training before allowing clinical protocols to be initiated. Inadequate corporate monitoring and quality-assurance auditing are likely responsible for these failures.

    Needless to say, FDA inspected the sponsor after inspecting the clinical investigator.

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