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.