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