Review
The interface between publicly funded and industry-funded research in pediatric psychopharmacology: opportunities for integration and collaboration

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Abstract

Pediatric psychopharmacology research is undergoing a major expansion consequent to increasing use of psychotropic medications in children and recent legislative incentives to industry. In this rapidly changing context, the interface between publicly and privately funded research needs to be reconsidered to integrate activities and avoid unnecessary duplication of efforts. Once, by default, the almost exclusive domain of public research, child research is now increasingly funded by industry. There are, however, important issues unlikely to be addressed through private funding for which public support is needed, such as direct comparisons between active medications, between pharmacological and psychosocial interventions, or between combined and single treatment modalities; development of effective treatment strategies for patients unresponsive to first-line treatments; development of better research methods to assess efficacy and safety; identification of moderators and mechanisms of treatment response; and impact of treatment on illness course and prognosis. Industry-sponsored research is limited by the restricted access to proprietary databases, which impedes independent analyses and meta-analyses. Translation of basic neuroscience discoveries into treatment applications for children with mental illness is a critical area of inquiry that can benefit from integration of efforts and collaborations among academia, government, and industry.

Section snippets

Industry-funded research

In medicine, industry is the main source of funding for clinical drug development. It is estimated that industry supports about 70% of all the costs of clinical trials in the United States (Bodenheimer 2000). In Europe, the rate is about 90% (Fegert 2003b). But, until recently, the involvement of industry in pediatric psychopharmacology has been, with few exceptions like that of clomipramine (DeVeaugh-Geiss et al 1992), rather limited. For instance, only one of the eight placebo-controlled

Government-funded research

Public funding for research in pediatric psychopharmacology has grown substantially during the last few years. Within the NIMH Child and Adolescent Treatment and Preventive Intervention Research Branch, which funds extramural intervention research in children, funding for pediatric psychopharmacology was about $39 million in 2003, more than three times what it was in 1997. About half of these funds support studies comparing the relative efficacy of pharmacotherapy with psychosocial

Research funded by private not-for-profit institutions

Private foundations have provided important financial support for innovative pilot studies in pediatric psychopharmacology. For instance, the Stanley Foundation has supported research in bipolar disorder that included testing of mood stabilizers for efficacy and tolerability in children (Kowatch et al 2000). The MacArthur Foundation has been active in supporting conferences and reports on ethical aspects and human subject protection issues that are relevant to child psychopharmacology research.

Collaborations among academia, industry, and government

In most cases, industry-sponsored clinical research are, in fact, collaborations between industry and academia. Typically, industry supplies study drugs, financial resources, quality control, data management, and statistical analyses. Some of these functions are often delegated by industry to separate contract research organizations. The protocol is often drafted by industry and finalized with the input of the investigators. The investigators are responsible for the identification and selection

Other essential parties not here discussed

We have here examined and discussed some aspects of the interface among some of the critical players in child psychopharmacology research: academia, government, industry, and private not-for-profit foundations. Other players who were not discussed are essential to this area of research, in particular, children, families, bioethicists, and patient advocates. Indeed, research in pediatric psychopharmacology requires the participation, collaboration, and integration of efforts of multiple partners.

Conclusions

Recent marketing and regulatory changes are profoundly impacting the funding scenario in pediatric psychopharmacology research. With powerful incentives to industry for sponsoring pharmacokinetics studies and placebo-controlled efficacy trials for drugs with patent coverage, government-funded research can now refocus on other more complex studies that will, among others, compare active treatments; inform on long-term impact on course of illness and distal outcomes; advance research methodology,

Acknowledgements

Financial disclosure (relative to the last 2 years): MAR received research support from National Institute of Mental Health (NIMH) and Pfizer and speaker or consultant honoraria from Pfizer, Sanofi-Synthelabo, Forest, and Janssen. LLG received research grants from NIMH, Eli Lilly, Celltech, Shire, Cephalon, Novartis, and Noven, and consultant honoraria and/or travel support from Bristol-Myers Squibb, Pfizer, Janssen, Janssen-Cilag, Novartis, Celltech, Shire, and Cephalon. JMF received research

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