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EDITORIALS: Rosalind L Smyth Making information about clinical trials publicly available BMJ 2009; 338: b2473 [Full text]

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Dr David Egilman

David egilman   (28 June 2009)

Astronomical data

Norman R Williams   (8 July 2009)

Wrong approach

Vasiliy V Vlassov   (22 August 2009)

Dr David Egilman 28 June 2009
David egilman, boss Attleboro Ma 02703 Send response to journal: Re: Dr David Egilman	In a world of globalization it is time to require that the results and origional protocols of all trials conducted anywhere be published. The location where a trial is conducted is not the major concern in determining the relevance of the results. The EU regulatory agencies demand production of non-EU studies; they are equally relevant to practicing doctors. This will prevent companies from moving research to developing countries as a way of hiding results. Competing interests: I have serves as an expert witness in litigation at the request of patients who were injured as a result of corporate negligence.
Astronomical data 8 July 2009
Norman R Williams, Senior Clinical Project Manager UCL Medical School, Whittington Campus, London N19 5LW Send response to journal: Re: Astronomical data	Astronomers have been making their raw data publicly available for some time, after a suitable delay to enable those who came up with the idea (and the funding) to perform the first analyses. For example, one organisation releases data to the public 18 months after archiving (http://www.ukidss.org/). Perhaps a suitable time for release of data held by pharmaceutical companies would be shortly after the patent for the drug has expired. Secrecy might produce short-term gains, but in the longer run it can only hinder progress. Competing interests: None declared
Wrong approach 22 August 2009
Vasiliy V Vlassov, Professor Moscow 109451 Send response to journal: Re: Wrong approach	What Mr Williams proposed - to have trials' data open AFTER THE PATENT EXPIRED is completely wrong. Patent is about the exclusive right to produce and trade the product. The trial's data is about efficacy and safety of the product. With current long-long patent times such 'openness' of trials' data may means that the full data on safety will not be available for 15-20 years. Currently, during this time many new drugs are erazed from the marked (up to 1/4). Many of them - because of the inappropriate collection, analysis or presentation of the information by the sponsors of the trials. Proposal to keep in secrecy trial data for such long time is against the public good. Realistic estimate of the period of the exclusive use of trial data by sponsor leads to proposal of the 2-4 years period, no more. Competing interests: None declared