Rapid Responses to:
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Rapid Responses: Rapid Responses published:
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![[Read Rapid Response]](/icons/misc/sectionDOWN.gif)
Wrong web address and wrong date
- Karmela Krleza-Jeric (23 April 2005)
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Trial Registration: Putting Principles into Practice
- Ronald L Krall, Frank Rockhold (18 May 2005)
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Karmela Krleza-Jeric, clinical research officer Canadian Institutes of Health Research, Ottawa
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Dear readers, We made two errors in the Next Steps part of our education and debate paper on Ottawa Statement Please note, that - the meeting on the operationalisation of principles of trial registration will take place on 23rd (and not 22nd) of May in Portland, Oregon. - the Ottawa group website address is: http://ottawagroup.ohri.ca (instead of the address which includes 'www') We apologise for any inconvenience that the incorrect information might have caused. Sincerely Karmela Krleza-Jeric Competing interests: None declared |
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Ronald L Krall, Senior Vice President, Worldwide Development GlaxoSmithKline, Upper Merion, PA 19087, USA, Frank Rockhold
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To the Editor: GlaxoSmithKline would like to join the signers of the Ottawa Statement in advocating transparency of clinical data. The Statement adds yet another endorsement of the principle that descriptions of clinical trials should be disclosed as those trials get under way and that the results should then be reported in a timely manner. Our company already gives notice of our active trials and posts results concerning marketed products in considerable detail by means of electronic databases. Nevertheless, we believe certain particulars in the Statement merit further scrutiny. Notice of active patient trials should unquestionably be given in sufficient detail to alert physicians and patients who may wish to participate in those trials, and to create a record to track for subsequent disclosure. Yet there is reason for concern about the amount of detail called for by the Statement, such as full protocols and protocol amendments. That so much disclosure at such an early stage will serve patients has not been demonstrated nor convincingly argued. What premature disclosure might do instead is to jeopardize the competitive investment which underlies the creation of new medicines. It is not as if much of this information (e.g. primary and secondary endpoints) will be not publicly available, for it will be posted to databases once the trials are completed, at least for marketed products. A middle way suggests itself. What all parties to this discussion share is the recognition that medical-journal editors reviewing papers based on clinical trials need access to information that will verify the original design of those trials. This information could be placed in a non -public repository for subsequent disclosure to editors on a confidential basis prior to publication. Other parts of the Statement also deserve further consideration, such as whether Institutional Review Boards should be put in the position of monitoring compliance of posting requirements, and whether patients are served by the reporting of results for experimental drugs that never reach the market, except insofar as those results inform the use of products on the market already. But notwithstanding the reservations expressed here, we reiterate our support for the principle of transparency and look forward to working with all interested parties to improve still more upon the rapid progress made over the past year. Ronald Krall
Frank Rockhold
Competing interests: Employees of GlaxoSmithKline |
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