AAGP Position Statement: Clinical Trials Registry
Adopted by the Board of Directors of the American Association
for Geriatric Psychiatry in November 2005
This statement reflects the position of the American Association
for Geriatric Psychiatry regarding a centralized clinical
trials registry. The AAGP is in agreement with the registry
guidelines proposed by the American Medical Association and
supports their assertion that a mandatory registry is essential
in ensuring that complete and unbiased information will be
publicly available to clinicians and researchers. Full access
to safety and efficacy data, including reasons for early termination,
is of critical importance in conveying the best possible information
to colleagues in the field as well as maintaining public trust
in psychiatric research.
Specifically, the AAGP supports the following guidelines
as proposed by the AMA:
- The inclusion of phase II and III clinical trials in support
of a new drug, biologic or device application as well as
post-marketing studies and other trials designed to test
a therapeutic intervention;
- The availability of identifying information such as the
name of the trial sponsor, sources of funding, a unique
identifier and contact information for the person responsible
for the clinical trial;
- The inclusion of details such as the trial purpose and
objective, the study design, the population and diseases
being studied and the dates the trial began and ended in
a simple, easy-to-understand format;
- A requirement for registration as a condition of approval
from Institutional Review Boards to ensure that clinical
trials are reported to the registry; and,
- Publicly available clinical trial results and an efficient
link to published journal articles or clinical trial reports.
If a trial was terminated early, the reason for such termination
should be explained.
The AAGP recognizes that there will be many practical challenges
in creating and enforcing such a registry. However, the successful
implementation of a public registry may achieve a number of
positive objectives as follows: a) to promote the disclosure
of trial results for consumer awareness, b) to promote disclosure
of data for clinicians to help direct patient care, and c)
to publicly establish an a priori plan for data analysis and
publication purposes. Regarding the latter issue of publication,
the AAGP supports the position of the International Committee
of Medical Journal Editors (ICMJE), and would like to offer
the following important points regarding the publication of
studies involving older adults:
Older adults constitute a vulnerable patient group that
has unique issues of medical comorbidity and functional
disabilities. Consequently, sample sizes in studies of older
adults tend to be smaller and clinical trials may be single-site
or conducted at a limited number of sites, such that they
may escape attention before completion and presentation.
The special vulnerability of older adults to serious adverse
events may complicate or limit the interpretation of outcomes
and create challenges in quantifying the positive effects
of treatment. It is therefore particularly important that
all such trials are published, regardless of whether the
results are favorable, in an effort to enhance the scientific
evidence behind various treatment options and allow the
best possible estimation of the risk/benefit ratio for any
given intervention.
Finally, older adults often do not meet specific DSM criteria,
as they tend to suffer significant distress and disability
from subsyndromal illness or mixed features of more than
one disorder. Hence current diagnostic criteria do not always
optimally reflect the spectrum of symptoms experienced by
older persons. Clinicians therefore need access to all trial
results that may shed light on a variety of symptom clusters,
as well as data regarding patient subgroups or characteristics
that may be uniquely responsive to a given treatment. This
situation is quite distinct from current practices in many
large-scale studies, where published results are more likely
to include patients with limited medical comorbidity who
meet narrowly defined diagnostic criteria. Broader dissemination
of all trial results can help clinicians better interpret
the possible benefits versus risks of an intervention for
an individual elder who may have subsyndromal or mixed symptoms.
With these points in mind, the AAGP wishes to endorse the
guidelines put forward by the AMA outlining the essential
registry elements as well as the goals of the ICMJE regarding
a registration requirement for publications.
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