Good Publication Practice for Communicating Company-Sponsored Medical Research: GPP3.

This updated Good Publication Practice (GPP) guideline, known as GPP3, builds on earlier versions and provides recommendations for individuals and organizations that contribute to the publication of research results sponsored or supported by pharmaceutical, medical device, diagnostics, and biotechnology companies. The recommendations are designed to help individuals and organizations maintain ethical and transparent publication practices and comply with legal and regulatory requirements. These recommendations cover publications in peer-reviewed journals and presentations (oral or poster) at scientific congresses. The International Society for Medical Publication Professionals invited more than 3000 professionals worldwide to apply for a position on the steering committee, or as a reviewer, for this guideline. The GPP2 authors reviewed all applications (n = 241) and assembled an 18-member steering committee that represented 7 countries and a diversity of publication professions and institutions. From the 174 selected reviewers, 94 sent comments on the second draft, which steering committee members incorporated after discussion and consensus. The resulting guideline includes new sections (Principles of Good Publication Practice for Company-Sponsored Medical Research, Data Sharing, Studies That Should Be Published, and Plagiarism), expands guidance on the International Committee of Medical Journal Editors' authorship criteria and common authorship issues, improves clarity on appropriate author payment and reimbursement, and expands information on the role of medical writers. By following good publication practices (including GPP3), individuals and organizations will show integrity; accountability; and responsibility for accurate, complete, and transparent reporting in their publications and presentations.

Quadrivalent meningococcal vaccines: hyporesponsiveness as an important consideration when choosing between the use of conjugate vaccine or polysaccharide vaccine.

Regional variations in the incidence and the distribution of serogroups which are responsible of meningococcal disease necessitate multivalent vaccines to ensure broad coverage for travelers. For almost 30 years, this has been provided by quadrivalent polysaccharide vaccine to protect against serogroups A, C, W-135 and Y, but with the advent of quadrivalent conjugate vaccines is there still a case to use the polysaccharide? The well documented hyporesponsiveness induced by polysaccharide vaccines after repeated administration, most clearly observed against serogroup C, suggest that, where available, conjugate vaccines should always be considered ahead of polysaccharide vaccine.

International Society for Medical Publication Professionals (ISMPP) position statement: the role of the professional medical writer.

The International Society for Medical Publication Professionals (ISMPP) is an independent, nonprofit professional association with members from the pharmaceutical, medical device, and biotechnology industries; publication planning and medical communications companies; academia; and medical journal staffs, including editors and publishers. ISMPP's mission is to support the educational needs of medical publication professionals by providing a forum to facilitate awareness and development of best practices in publication planning and implementation, and fostering consensus policies related to medical publishing. This position statement reflects our concern about the current climate of mistrust regarding the use of professional medical writers in the preparation of manuscripts. We acknowledge the skills and training of medical writing professionals and support their role in working with research teams to develop clear and concise manuscripts in a timely fashion. Further, we support complete and transparent disclosure of the role of the medical writer and the source of funding for the writing initiative in order to build awareness of, and trust in, the appropriate use of medical writing professionals. ISMPP endorses use of the contributorship model, which offers detailed information on the roles of all who participated in planning, conducting, developing, and publishing medical research. Further, we propose that this model be integrated into the standard operating procedures of the diverse organizations that comprise our membership because the responsibility for authorship disclosure is shared by sponsors, authors, study investigators, and medical writers. Finally, we commend the many organizations that have worked to increase recognition and understanding of the legitimate role of the medical writer, and are eager to work in concert with them to ensure the rigorous maintenance of all ethical standards for reporting the results of medical research.

Comparison of two combined vaccines against typhoid fever and hepatitis A in healthy adults.

A prospective, randomised, observer-blind, comparative study was performed in healthy adults with a new hepatitis A/typhoid combined vaccine, Viatim, and the marketed Hepatyrix vaccine. Both vaccines induced high levels of protective antibodies, but typhoid responses were higher and hepatitis A responses more rapid with Viatim compared with Hepatyrix. Both vaccines were well tolerated, no serious adverse events (SAEs) occurred, but more Viatim vaccinees had more mild or moderate local reactions (82.7%) than Hepatyrix (53.1%, p < 0.001). In this direct comparison Viatim induced more local reactions, but elicited a more rapid and higher immune response to both antigens than Hepatyrix.

Efficacy of rabies immunoglobulins in an experimental post-exposure prophylaxis rodent model.

In a recently published Syrian hamster animal challenge study [Vaccine 19 (2001) 2273], a highly purified, heat-treated equine rabies immunoglobulin (pERIG HT, Favirab) did not elicit satisfactory protection. The efficacies of this batch, a second stage pERIG HT batch and reference RIG preparations (Imorab, Imogam Rage pasteurised, Berna antiserum) were compared in mice challenged with either Ariana canine field strain or CVS strain. Survival rates against Ariana challenge with the second pERIG HT batch were indistinguishable from those of other licensed preparations (83-90% survival), but the deficient batch did not provide satisfactory protection (53%). These data confirm the inadequate response to a first stage pERIG HT batch, but a current batch provides equivalent protection to that afforded by licensed HRIG and ERIG preparations.