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LETTERS: Eric S Kilpatrick Licensing diagnostic tests may benefit everyone BMJ 2005; 330: 1330 [Full text]

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Setting to work on a licensing program

Giuseppe Giocoli   (7 June 2005)

Setting to work on a licensing program 7 June 2005
Giuseppe Giocoli, GdL EBM Associazione Microbiologi Clinici Italiani V.Farini, 81 20159 Milano (Italia) Send response to journal: Re: Setting to work on a licensing program	I fully agree with Kilpatrick’s careful thoughts about benefits from licensing diagnostic tests (1). Though, I wonder about the way of filling the gap between laboratory people (and representative Academies) indulging their belief that they only have to prove their tests are analytically accurate, and those “willing to participate together as a network to carry out diagnostic trials” (1) to prove that their findings are of any use in managing patients. In my opinion, the very first approach towards the target is implementing the endorsement of the STARD initiative (2) for reporting observational diagnostic studies by medical and laboratory journals. The STARD checklist can be seen as a ladder to climb from the analytical world to the world of clinical utility of diagnostic tests - whether or not randomised controlled trial be necessary or best subsequent steps. To my knowledge, no one has tried yet to carry out a research about STARD similar to the recent one about CONSORT for randomized trials (3); it is a safe bet that its conclusions would be just the same: “Journals should be more explicit in their expectations of authors and ensure the accuracy of their instructions to authors”. No STARD for primary diagnostic studies, no diagnostic trials, no licensing diagnostic tests. Giuseppe Giocoli, MD (retired) 1. Licensing diagnostic tests may benefit everyone. Eric S Kilpatrick. BMJ 2005; 330:1330 2. The STARD Initiative -- Towards Complete and Accurate Reporting of Studies on Diagnostic Accuracy http://www.consort- statement.org/stardstatement.htm 3. Endorsement of the CONSORT statement by high impact medical journals: survey of instructions for authors. Douglas G Altman for the CONSORT Group. BMJ 2005;330:1056–7 Competing interests: None declared