Intended for healthcare professionals

Rapid response to:

Education And Debate

Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa statement (part 1)

BMJ 2005; 330 doi: https://doi.org/10.1136/bmj.330.7497.956 (Published 21 April 2005) Cite this as: BMJ 2005;330:956

Rapid Response:

Trial Registration: Putting Principles into Practice

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

Senior Vice President, Worldwide Development

GlaxoSmithKline

Frank Rockhold

Senior Vice President, Biomedical Data Sciences

GlaxoSmithKline

Competing interests:
Employees of GlaxoSmithKline

Competing interests: No competing interests

18 May 2005
Ronald L Krall
Senior Vice President, Worldwide Development
Frank Rockhold
GlaxoSmithKline, Upper Merion, PA 19087, USA