Child and Adolescent Psychopharmacology in the New Millennium: A Workshop for Academia, Industry, and Government
To give academic researchers, government officials, and industry scientists an opportunity to assess the state of pediatric psychopharmacology and identify challenges facing professionals in the field.
Increased federal spending and the introduction of pediatric exclusivity led to large increases in pediatric psychopharmacology research in the 1990s. Despite the increase in research, concerns exist about methods and incentives for making new medications available for use in pediatric psychiatric disorders. In recognition of these concerns, the Duke Clinical Research Institute held a roundtable in September 2004. Participants from the National Institutes of Health, regulatory agencies, academia, and the pharmaceutical industry spoke about the effects of government regulations such as the U.S. Food and Drug Administration Modernization Act and the Pediatric Research Equity Act on pediatric research from academic, clinical, and industry perspectives, and bioethical considerations of such research.
To ensure development of new drugs for treating psychiatric disorders in children and adolescents, we must address the challenges posed by the regulatory environment governing pediatric psychopharmacology research. Strategies were identified for improving the evidence base for psychopharmacologic interventions in youth before widespread use and for more effectively defining a research agenda for the future.
Available from: Alfiee M. Breland-Noble
- "In actuality, many lessons have been learned in the process of moving CAPTN from concept to functioning PCT network that are of general importance for practical clinical trialists and, in particular, for those seeking to create multi-center clinical trials networks in pediatric and adult psychiatry. In previous reports we documented the need for PCTs in pediatric psychopharmacology , described common obstacles to conducting PCTs in psychiatry and proposed a set of solutions , and presented a theoretical rationale for CAPTN . In this article, we specifically focus on infrastructure development issues (the "hardware") that enables practical clinical trials (the "software") to run on CAPTN. "
[Show abstract] [Hide abstract]
ABSTRACT: In 2003, the National Institute of Mental Health funded the Child and Adolescent Psychiatry Trials Network (CAPTN) under the Advanced Center for Services and Intervention Research (ACSIR) mechanism. At the time, CAPTN was believed to be both a highly innovative undertaking and a highly speculative one. One reviewer even suggested that CAPTN was "unlikely to succeed, but would be a valuable learning experience for the field."
To describe valuable lessons learned in building a clinical research network in pediatric psychiatry, including innovations intended to decrease barriers to research participation.
The CAPTN Team has completed construction of the CAPTN network infrastructure, conducted a large, multi-center psychometric study of a novel adverse event reporting tool, and initiated a large antidepressant safety registry and linked pharmacogenomic study focused on severe adverse events. Specific challenges overcome included establishing structures for network organization and governance; recruiting over 150 active CAPTN participants and 15 child psychiatry training programs; developing and implementing procedures for site contracts, regulatory compliance, indemnification and malpractice coverage, human subjects protection training and IRB approval; and constructing an innovative electronic casa report form (eCRF) running on a web-based electronic data capture system; and, finally, establishing procedures for audit trail oversight requirements put forward by, among others, the Food and Drug Administration (FDA).
Given stable funding for network construction and maintenance, our experience demonstrates that judicious use of web-based technologies for profiling investigators, investigator training, and capturing clinical trials data, when coupled to innovative approaches to network governance, data management and site management, can reduce the costs and burden and improve the feasibility of incorporating clinical research into routine clinical practice. Having successfully achieved its initial aim of constructing a network infrastructure, CAPTN is now a capable platform for large safety registries, pharmacogenetic studies, and randomized practical clinical trials in pediatric psychiatry.
Available from: PubMed Central
- "Enrollment in clinical trials is often a slow process that takes several years to be completed. Various strategies for engaging both practitioners and potential research participants have been proposed, and greater attention on the part of researchers to the perspectives and needs of children and families have been recommended [43,48]. "
[Show abstract] [Hide abstract]
ABSTRACT: Research in pediatric pharmacology has undergone major changes in the last ten years, with an expansion in both publicly and privately funded activities. A number of pharmacokinetics studies and multi-site controlled efficacy trials have been conducted, so that treatment of children and adolescents can now be better informed and evidence-based. Regulatory financial incentives to industry in return for studies on drugs still covered by patent exclusivity have resulted in a substantial increase in pediatric research funded by pharmaceutical companies. In parallel, public funding has supported research on off-patent medications and other clinical important aspects of treatment, such as comparisons between active treatments, including non-pharmacological interventions. With greater interest by industry in pediatric research, the role of government funding agencies has been redefined to avoid duplication and ensure better integration of efforts and utilization of resources. The present review discusses some of the recent developments in pediatric pharmacology with focus on psychiatric medications.
Available from: medworksmedia.com
[Show abstract] [Hide abstract]
ABSTRACT: Psychotropic medications are increasingly being used by children and adolescents. In an earlier report, we noted that boys were receiving atypical antipsychotics more frequently than were girls, (70% of the claims). Since diagnosis was not available in the data, we were unable to ascertain the reasons for this. In the present analysis, we examined a large clinical mental health database to ascertain the reason for antipsychotic use.We evaluated the extent to which race, gender, age and type of diagnosis accounted for atypical antipsychotic use in children. Methods: The authors used an anonymous clinical database created at Duke University Medical Center. The database is based on the clinical document of care in the Department of Psychiatry. The data are de-identified per HIPAA guidelines and has an IRB exemption for use in clinical research. Patients analyzed were seen from 1999 to 2005 and were below the age of 18 at the time of clinical care. A total 3,268 patients, with a total of 7,701 visits comprise the analysis sample. Age, gender, race, and diagnosis were extracted as predictors of use of atypical antipsychotics. Results: Males and older children were also more likely to use an atypical. African Americans were slightly more likely to use an atypical than whites. Patients whose diagnoses were classified as either psychotic or internalizing were also more likely to use an antipsychotic. Conclusion: The underlying reasons for the high level of use of atypicals in boys and in African Americans need to be investigated further.
Data provided are for informational purposes only. Although carefully collected, accuracy cannot be guaranteed. The impact factor represents a rough estimation of the journal's impact factor and does not reflect the actual current impact factor. Publisher conditions are provided by RoMEO. Differing provisions from the publisher's actual policy or licence agreement may be applicable.