Open access to industry's clinically relevant data

Editor - As reported in Dr. Herxheimer’s editorial,(1) access to
clinically relevant data from trials is difficult, when possible, and this
is due mostly to industry’s argument that it owns the research it has paid
for and that revealing results could help competitors. However, a few
events that occurred during the past few months have contributed to
supporting efforts devoted to public disclosure.(2) Access to data is
necessary to patients, doctors, and researchers in order to make optimal
drug therapy choices, maximising benefits and minimising harms.(1)
Europe’s new clinical trial database, EudraCT, has been criticized(3)
because, although it aims to improve access to information on clinical
trials in the community, it is accessible only to the Competent
Authorities of the Member States, the EMEA and the Commission. In fact,
its primary objectives are to provide European regulatory authorities with
an overview of interventional clinical trials of medicinal products in the
Community in order to facilitate communication on the trials, allow for
greater supervision of the trials and of medicinal product development,
and provide better protection of clinical trial subjects or patients
receiving investigational medicinal products (see
http://eudract.emea.eu.int/docs/Detailed%20guidance%20EudraCT.pdf).

The problems with such limited access are that it can lead to
duplication of effort by researchers, waste of resources, and poorly
directed funding.(4,5) More importantly, it will make it more difficult to
decide whether commonly used treatments are effective.(3)

Many attempts at creating publicly accessible, international clinical
trial registries have been made in order to overcome issues related to the
inaccessibility of trial information, such as the metaRegister of
Controlled Trials (http://controlled-trials.com/mrct). The paediatric
population, like other sub-populations such as those regarding specific
diseases for which there is insufficient knowledge, are more strongly
affected by limits to information. This led to the creation of an
international paediatric clinical trial register in 2003. The project,
entitled The European register of clinical trials on medicines for
children - Drug Evaluation in Children (DEC-net), is coordinated by the
Laboratory of Mother and Child Health of the "Mario Negri" Institute for
Pharmacological Research in Milan and involves a core group of members
from France, Italy, Spain, and the United Kingdom. It is unique in that it
is the first population oriented clinical trial register. The register,
which has just recently been activated with data from the first few trial
protocols inputted, is supported by the European Community as part of its
Fifth Framework Programme, Thematic Programme "Quality of Life" (contract
QLG4-CT-2002-01054). The members have begun to input trial information.
The DEC-net register’s main objective is to help identify the few
paediatric studies being carried out; this can be useful for researchers
and health care workers to increase their knowledge on drug therapies
derived from them. DEC-net also represents a resource for planning new
studies, promoting communication and collaboration among researchers,
facilitating patient access and recruitment into trials, preventing trial
duplication and inappropriate funding, and identifying the therapeutic
needs of children that remain neglected.

The register will be freely accessible to anyone interested in
information on paediatric drug therapy clinical trials. The information
will be displayed in two different formats, a simple one intended for
parents/the lay public and a more advanced one for health professionals,
although users will be free to choose between views. The information
includes the protocol title, International Standard Randomized Controlled
Trial Number (ISRCTN), EudraCT number, current trial status, disease,
gender, age range, purpose, main investigator contact details, countries
involved (if multinational), experimental drug, trial phase, type of
study, and inclusion criteria. Some of the information will also be
provided in the original language (Italian, Spanish, or French). Further
information on the DEC-net register and on related issues can be found at
www.dec-net.org.

Different forms of collaboration with all "actors" who are
potentially interested in clinical trials in children are currently being
discussed: ethics committees, scientific societies, patient associations,
pharmaceutical industries, and regulatory authorities. Such an initiative
could be an example for improving and further developing informed
participation and management in clinical trials. Although some of the data
concerning paediatric clinical trials may become public also in EudraCT’s
future, to achieve a satisfactory level of public disclosure it is
essential that registries, such as those announced by some pharmaceutical
companies, limit their access limitations so as to act as proposals
instead of obstacles to the informed participation of professionals and
lay people in the health field.

References
1. Herxheimer A. Open access to industry's clinically relevant data. Br
Med J 2004;329:64-5.
2. Steinbrook R. Public registration of clinical trials. N Engl J Med
2004;351:315.
3. Burgermeister J. New EU trials database is criticised for lack of
openness. Br Med J 2004;328:1094.
4. Clavenna A, Pandolfini C, Bonati M. Public disclosure of clinical
trials in children. Curr Ther Res Clin Exp 2002;63(10):707-16.
5. Tonks A. Registering clinical trials. Br Med J 1999;319:1565-8.

Competing interests:
None declared