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We applaud Decullier et al for their insightful evaluation of some
factors
influencing publication of health-related research projects. (1) In
contrast to
the approach taken by others who have used national registries (2,3) or
sponsoring agency records, (4) these authors have examined research
activity
outcomes from the perspective of research ethics approval. Clinical
trial
registration is not universally required and sponsor databases are
necessarily
limited in scope. However, research committee approval is required of all
research involving human subjects and includes protocols regardless of
funding status and origin. We strongly agree with this approach and feel
that
research ethics approval represents the earliest convergence in the birth
of
human-subjects research projects, making them an ideal perspective from
which to study the subsequent events in their life cycle.
Failure to disseminate results is considered research misconduct and
is an
urgent scientific and ethical concern. (5,6) As confirmed by the
authors,
selective dissemination of research results in publication bias, typically
skewing the literature toward reports with positive findings. However, in
their
discussion, the authors appear to conflate the issue of clinical trial
registration with that of selective dissemination, implying that
registration
will remedy this situation. While the registration models promoted by the
International Council of Medical Journal Editors, the Canadian Institutes
of
Health Research, European regulatory agencies and others increase
transparency, they are not designed to ensure registered protocols result
in
publication; instead they are designed to ensure publications are only
spawned from registered protocols.
Preliminary results from a study we are undertaking at a major
Canadian
medical-doctoral university indicate that while meticulous financial
records of
research activity are kept, mechanisms for identifying and tracking the
dissemination status of human-subjects research projects are virtually
nonexistent. We hope to build on the work of Decullier et al. by
characterizing the spectrum of dissemination (e.g. from local presentation
to
global distribution) that is relevant to clinicians in contemporary
practice, to
identify trends over time in modes of dissemination (e.g. oral, written
and
electronic), and to clarify what mechanisms are required to increase rates
of
dissemination as a means of enhancing the value, integrity, and the
public’s
trust in clinical research.
Division of Clinical Pharmacy,
Faculty of Pharmaceutical Sciences,
University of British Columbia,
Vancouver, BC, Canada
References
1. Decullier E, Lheritier V, Chapuis F. Fate of biomedical research
protocols
and publication bias in France: retrospective cohort study. Bmj 2005; Jul
2;331(7507):19.
2. Pich J, Carne X, Arnaiz JA, Gomez B, Trilla A, Rodes J. Role of a
research
ethics committee in follow-up and publication of results. Lancet 2003; Mar
22;361(9362):1015-6.
4. Ioannidis JP. Effect of the statistical significance of results on the
time to
completion and publication of randomized efficacy trials. Jama 1998; Jan
28;279(4):281-6.
5. Chalmers I. Underreporting research is scientific misconduct. Jama
1990;
Mar 9;263(10):1405-. What is research misconduct? London: BMJ Publishing
Group; 2000.
6. Tri-Council Policy Statement: Ethical Conduct For Research Involving
Humans. Health Canada Panel on Research Ethics; 1998 (with 2000, 2002
updates).
Competing interests:
None declared
Competing interests:
No competing interests
15 July 2005
James P. McCormack
Professor
Peter S. Loewen, Peter J. Jewesson
University of British Columbia 2146 East Mall Vancouver BC Canada V6T 1W5
The paper by Decullier and colleagues provides fresh impetus for the
imperative that all clinical trials should be registered. Although 38% of
studies overall have been published in the 10 years since approval was
sought, only 26% (80/303) of the randomised controlled trials presented
for ethical approval have been published (excluding those still ongoing or
that failed to start, table 2, p21). Efforts to base treatment decisions
on summaries of evidence are grounded in the completeness of the available
evidence. If the failure to publish trial evidence observed by Decullier
et al is widely replicated then many summaries and thus treatment
decisions may be suspect. In addition to the International Committee of
Medical Editors requiring prospective public domain registration of
trials, ethics committees world-wide should require evidence of trial
registration before granting ethical approval. The net must tighten so
there is little chance of evidence not being employed to support clinical
decision-making.
Competing interests:
None declared
Competing interests:
No competing interests
04 July 2005
Andrew Jull
Research Fellow
Clinical Trials Research Unit, School of Population Health, University of Auckland, New Zealand
Publication bias, selective dissemination and trial registries
Dear Editors:
We applaud Decullier et al for their insightful evaluation of some
factors
influencing publication of health-related research projects. (1) In
contrast to
the approach taken by others who have used national registries (2,3) or
sponsoring agency records, (4) these authors have examined research
activity
outcomes from the perspective of research ethics approval. Clinical
trial
registration is not universally required and sponsor databases are
necessarily
limited in scope. However, research committee approval is required of all
research involving human subjects and includes protocols regardless of
funding status and origin. We strongly agree with this approach and feel
that
research ethics approval represents the earliest convergence in the birth
of
human-subjects research projects, making them an ideal perspective from
which to study the subsequent events in their life cycle.
Failure to disseminate results is considered research misconduct and
is an
urgent scientific and ethical concern. (5,6) As confirmed by the
authors,
selective dissemination of research results in publication bias, typically
skewing the literature toward reports with positive findings. However, in
their
discussion, the authors appear to conflate the issue of clinical trial
registration with that of selective dissemination, implying that
registration
will remedy this situation. While the registration models promoted by the
International Council of Medical Journal Editors, the Canadian Institutes
of
Health Research, European regulatory agencies and others increase
transparency, they are not designed to ensure registered protocols result
in
publication; instead they are designed to ensure publications are only
spawned from registered protocols.
Preliminary results from a study we are undertaking at a major
Canadian
medical-doctoral university indicate that while meticulous financial
records of
research activity are kept, mechanisms for identifying and tracking the
dissemination status of human-subjects research projects are virtually
nonexistent. We hope to build on the work of Decullier et al. by
characterizing the spectrum of dissemination (e.g. from local presentation
to
global distribution) that is relevant to clinicians in contemporary
practice, to
identify trends over time in modes of dissemination (e.g. oral, written
and
electronic), and to clarify what mechanisms are required to increase rates
of
dissemination as a means of enhancing the value, integrity, and the
public’s
trust in clinical research.
James McCormack, PharmD, ACPR
Professor
jmccorma@interchange.ubc.ca
Peter Loewen, PharmD, ACPR, FCSHP
Associate Professor, Part Time
ploewen@interchange.ubc.ca
Peter Jewesson, PhD, ACPR, FCSHP
Professor
pjj@interchange.ubc.ca
Division of Clinical Pharmacy,
Faculty of Pharmaceutical Sciences,
University of British Columbia,
Vancouver, BC, Canada
References
1. Decullier E, Lheritier V, Chapuis F. Fate of biomedical research
protocols
and publication bias in France: retrospective cohort study. Bmj 2005; Jul
2;331(7507):19.
2. Pich J, Carne X, Arnaiz JA, Gomez B, Trilla A, Rodes J. Role of a
research
ethics committee in follow-up and publication of results. Lancet 2003; Mar
22;361(9362):1015-6.
3. Bardy AH. Bias in reporting clinical trials. Br J Clin Pharmacol 1998;
Aug;46
(2):147-50.
4. Ioannidis JP. Effect of the statistical significance of results on the
time to
completion and publication of randomized efficacy trials. Jama 1998; Jan
28;279(4):281-6.
5. Chalmers I. Underreporting research is scientific misconduct. Jama
1990;
Mar 9;263(10):1405-. What is research misconduct? London: BMJ Publishing
Group; 2000.
6. Tri-Council Policy Statement: Ethical Conduct For Research Involving
Humans. Health Canada Panel on Research Ethics; 1998 (with 2000, 2002
updates).
Competing interests:
None declared
Competing interests: No competing interests