Developing a National Registry of Pharmacologic and Biologic Clinical Trials Workshop Report (2006) / Chapter Skim
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Appendix D Published Journal Editorials
Appendix D Published Journal Editorials
Pages 81-90
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From page 81... ...
D Published Journal Editorials Clinical Trial Registration: A Statement from the International Committee of Medical Journal Editors Altruism and trust lie at the heart of research on human subjects. Altruistic individuals volunteer for research because they trust that their participation will contribute to improved health for others and that researchers will minimize risks to participants.
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82 CREATING A NATIONAL REGISTRY dence. We are far from this ideal at present, since trial registration is largely voluntary, registry data sets and public access to them vary, and registries contain only a small proportion of trials.
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APPENDIX D 83 Registration is only part of the means to an end; that end is full transparency with respect to performance and reporting of clinical trials. Research sponsors may argue that public registration of clinical trials will result in unnecessary bureaucratic delays and destroy their competitive edge by allowing competitors full access to their research plans.
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84 CREATING A NATIONAL REGISTRY Is This Clinical Trial Fully Registered? -- A Statement from the In ternational Committee of Medical Journal Editors Catherine D
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APPENDIX D 85 sors want to be sure that they understand ourrequirements, so that reports of their research will be eligible for editorial review. The purpose of this joint and simultaneously published editorial is to answer questions about the ICMJE initiative and to bring our position into harmony with that of others who are working toward the same end.
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From page 86... ...
86 CREATING A NATIONAL REGISTRY dress every key requirement that we established in our September 2004 editorial. The ICMJE supports the WHO minimal data set and has adopted it as the ICMJE's requirement: we will consider a trial for publication if the authors register it at inception by completing all 20 fields in the WHO minimal data set.
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APPENDIX D 87 9. Title of the study Brief title chosen by the research group (can be omitted if the re searchers wish)
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88 CREATING A NATIONAL REGISTRY 20. Key secondary outcomes The secondary outcomes specified in the protocol.
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APPENDIX D 89 Catherine D De Angelis, M.D., M.P.H.
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90 CREATING A NATIONAL REGISTRY REFERENCE De Angelis C, Drazen JM, Frizelle FA, et al.
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