Making information about clinical trials publicly available
BMJ 2009; 338 doi: https://doi.org/10.1136/bmj.b2473 (Published 25 June 2009) Cite this as: BMJ 2009;338:b2473
All rapid responses
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
Competing interests: No competing interests
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.
Competing interests: No competing interests
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
Competing interests: No competing interests