NEWS:

LATEST STUDIES:

Publications/Presentations

Presentations

A primary analysis of the first European, paediatric clinical trial register: DEC-net. III International Workshop onPaediatric & Perinatal Drug Therapy and Paediatric Clinical Trials (11-12 July 2005) Derby, UK. 11 July 2005.

A review of online, drug therapy clinical trial registers from a paediatric point of view. III International Workshop on Paediatric & Perinatal Drug Therapy and Paediatric Clinical Trials (11-12 July 2005) Derby, UK. 12 July 2005

DEC-NET: The Development of the European Register of Clinical Trials on Medicines for Children Portland, Oregon. May 2005.

DEC-NET: The First European Register of Clinical Trials on Medicines for Children. Paediatric Working Party (EMEA). 29 July 2005. London, UK.

Registro de ensayos clínicos Proyecto DEC-net. Annual Congress of the Spanish Society of Paediatrics (Asociación Española de Pediatría), Murcia, Spain. June 2005.

A European, paediatric, clinical trial registry, Milan, Italy. February 2004

DEC-net: the development of the European register of clinical trials on medicines for children, Genova, Italy. November 2004.

Registering trials in children in Europe and North America. II International Workshop on Paediatric & Perinatal Drug Therapy and Paediatric Clinical Trials (15-16 October 2004) London, Ontario, Canada. 16 October 2004.

The European register of clinical trials on medicines for children, Santander, Spain. October 2004

A European, paediatric, clinical trial registry, Milan, Italy. December 2003.

A European Clinical Trials Register for Children, Yorkshire, UK

Register-related

Bonati M, Pandolfini C. Trial registration, the ICMJE statement, and paediatric journals. Arch Dis Child 2006;91(1):93.

Bonati M, Pandolfini C. Trial registration, the ICMJE statement, and paediatric journals. Paediatr Anaesth 2006;16:92.

DEC-net website notice

Jacqz-Aigrain E, Zarrabian S, Pandolfini C, Bonati M, Sammons H, Choonara I, Danes I, Fuentes I, Arnau J. Le registre Européen des essais cliniques pédiatriques est une réalité [A complete clinical trial register is already a reality in the paediatric field]. Therapie 2006;61(2):121-4.

Jacqz-Aigrain E, Zarrabian S, Pandolfini C, Bonati M, Sammons H, Choonara I et al. DEC-net, le registre europeen des essais cliniques pediatriques, est une realite. [French] Arch Pediatr 2006;13:333-5.

Santoro E, Rossi V, Pandolfini C, Bonati M. DEC-net: the development of the European register of clinical trials on medicines for children. Clin Trials 2006;3:366-75.

Bonati M, Pandolfini C; DEC-net Collaborative Group. Pediatric clinical trials registry. CMAJ. 2005;172(9):1159-60

Bonati M, Pandolfini C; DEC-net collaborative group. A complete clinical trial register is already reality for paediatrics. Br Med J 2005;330(7489):480.

Bonati M, Pandolfini C; DEC-net Collaborative Group. Pediatric clinical trials registry. CMAJ. 2005 Apr 26;172(9):1159-60.

Bonati M, Pandolfini C; DEC-net collaborative group. More on compulsory registration of clinical trials: complete clinical trial register is already reality for paediatrics. BMJ. 2005 Feb 26;330(7489):480.

Fuentes Camps I, Danés Carreras I, Arnau de Bolós JM. Registros de ensayos clínicos y el proyecto DEC-net (Registro europeo de ensayos clínicos en niños. ICB digital 2005;38:2-5.

Pandolfini C, Bonati M. A review of online, drug therapy clinical trial registers from a paediatric point of view. Pediatr Perinat Drug Therapy 2005;6:181.

Pandolfini C, Bonati M. DEC-net: il registro europeo degli studi clinici pediatrici. I primi 200 protocolli inseriti. [Italian] Giornale Italiano di Farmacia Clinica 2005;19(4):408-10.

Sammons HM, Naylor C, Choonara I, Pandolfini C, Bonati M. Should paediatricians support the European Paediatric Clinical Trials Register? Arch Dis Child 2005;90(6):559-60.

Santoro E, Rossi V, Pandolfni C, Bonati M. DEC-net: the development of the European register of clinical trials on medicines for children [abstract]. Abstracts from the 26th Annual Meeting of the Society for Clinical Trials, 22-25 may, 2005, Portland, Oregon. Clinical Trials 2005;2:S40.

Santoro E, Rossi V, Pandolfini C, Bonati M. Dec-net: the first European register of clinical trials in children. Technol Health Care 2005;13:428-429.

Bonati M, Pandolfini C, Rossi V, Santoro E, Arnau JM, Fuentes I, Carreras ID, Camps IF, Castel Llobet JM, Jacqz-Aigrain E, Zarrabian S, Choonara I, Sammons H, Steingo J, Naylor C. A complete clinical trial register is already a reality for the paediatric field. Br Med J 2004; http://bmj.bmjjournals.com/cgi/eletters/329/7467/637#90155.

Bonati M, Pandolfini C, Rossi V, Santoro E, Arnau JM, Fuentes I, Castel Llobet JM, Jacqz-Aigrain E, Zarrabian S, Choonara I, Sammons H, Steingo J. Public disclosure of clinical trials. Br Med J 2004; bmj.bmjjournals.conm/cgi/eletters/329/7457/64#69125.

Bonati M, Pandolfini C, Rossi V, Santoro E, Arnau De Bolos JM, Carreras ID, Camps IF, Castel Llobet JM, Jacqz-Aigrain E, Zarrabian S, Choonara I, Sammons H, Steingo J. Launch of a European paediatric clinical trials register. Paed Perinat Dr Ther 2004;6:38-39.

Bonati M, Pandolfini C, Rossi V, Santoro E, de Bolos AJ, Carreras DI, Camps FI, Jacqz-Aigrain E, Choonara I, Sammons H, Steingo J. The first European registry for pediatric clinical trials: DEC-net. Assist Inferm Ric 2004 Apr-Jun;23(2):91-2. Italian.

Bonati M, Pandolfini C, Clavenna A. Disclosure of clinical trials in children. Science 2004 Sep 3;305(5689):1401.

Bonati M, Pandolfini C, Rossi V, Santoro E, Arnau De Bolos JM, Carreras ID, Camps IF, Castel Llobet JM, Jacqz-Aigrain E, Zarrabian S, Choonara I, Sammons H, Steingo J. Launch of a European paediatric clinical trials register. Paed Perinat Dr Ther 2004; 6:38-39.

Bonati M, Pandolfini C. DEC-net: il primo registro di studi clinici pediatrici. Medico e Bambino 2004;23:281.

Bonati M, Pandolfini C, Rossi V, Santoro E. Un registro degli studi clinici pediatrici: uno strumento dalla parte dei bambini. Giornale Italiano di Farmacia Clinica 2004;18:1-5.

Bonati M, Pandolfini C, Clavenna A. Disclosure of clinical trials in children. Science. 2004 Sep 3;305(5689):1401.

Danés Carreras I, Fuentes C, Arnau de Bolós JM, Pandolfini C, Bonati M, Sammons H, Choonara I, Jacqz-Aigrain E. Un registro europeo de ensayos clínicos en niños. An Pediatr (Barc) 2004;60(3):212-4.

Garattini S, Bonati M, Pandolfini C. Un registro europeo degli studi clinici pediatrici. R&P 2004;20:83-84.

I Danés Carreras, Fuentes Campsa I, Arnau de Bolósa JM, Pandolfini C, Bonati M, Sammonsc H, Choonara I, Jacqz-Aigrain E. Un registro europeo de ensayos clìnicos en ninos. An Pediatr (Barc) 2004;60(3):212-4.

Pandolfini C., Bonati M., Choonara I., Sammons H., Jacqz-Aigrain E., Danés I., Fuentes I., Arnau J. A European Clinical Trials Registry for Children Paed Perinat Dr Ther 2003;5(3):98-10.

Bonati M, Pandolfini C, Choonara I, Jacqz-Aigrain E, Arnau J Something is finally moving, at least in the paediatric field... BMJ 2002. http://bmj.com/cgi/eletters/325/7376/1314#28245

Clavenna A, Pandolfini C, Bonati M. Public disclosure of clinical trials in children. Curr Ther Res 2002;63:707-16.

Bonati M., Impicciatore P., Pandolfini C. Registering clinical trials. Br Med J 2000;320:1339-40.

Impicciatore P., Pandolfini C., Bonati M. Database could give children safer medicines. Nature 2000;405:882.

Bonati M., Choonara I., Hoppu K., Pons G., Seyberth H. Closing the gap in drug therapy. Lancet 1999;353:1625.

Cazzato T, Pandolfini C, Campi R, Bonati M; ACP Puglia-Basilicata Working Group. Drug prescribing in out-patient children in Southern Italy. Eur J Clin Pharmacol. 2001 Oct;57(8):611-6.

Off-label/Adverse drug reactions

Pandolfini C, Bonati M. A literature review on off-label drug use in children. Eur J Pediatr. 2005 Sep;164(9):552-8. Epub 2005 May 24.

Pandolfini C, Campi R, Clavenna A, Cazzato T, Bonati M. Italian paediatricians and off-label prescriptions: loyal to regulatory or guideline standards? Acta Paediatr. 2005 Jun;94(6):753-7.

Pandolfini C, Bonati M, Giozani M, Raffaelli MP, Rossi R, Serra G, et al. Off-label and unlicensed drug use in neonatal wards of three different Italian hospitals. Pediatr Perinat Drug Ther 2003;5:169.

Pandolfini C, Bonati M. Off-label drug use in children in Europe: a major health issue. Pharm Dev Regul 2003;1:133-43.

Pandolfini C., Impicciatore P., Provasi D., Rocchi F., Campi R., Bonati M. Off-label use of drugs in Italy: a prospective, observational and multicentre study Acta Paediatr 2002;91:339-47.

Impicciatore P., Choonara I., Clarkson A., Provasi D., Pandolfini C., Bonati M. Incidence of adverse drug reactions in paediatric in/out-patients: a systematic review and meta-analysis of prospective studies. Br J Clin Pharmacol 2001;52:77-83.

Conroy S., Choonara I., Impicciatore P., Mohn A., Arnell H., Rane A., et al. Survey of unlicensed and off label drug use in paediatric wards in European countries. Br Med J 2000;320:79.82.

Other

Bonati M, Pandolfini C. Is it time for a European formulary of paediatric medicines? Arch Dis Child. 2004 Sep;89(9):890-1.

Bonati M, Pandolfini C. Children need international formulary to guarantee rational use of drugs. BMJ. 2004 Jan 24;328(7433):227.

Impicciatore P, Pandolfini C, Bonati M. Database could give children safer medicines. Nature. 2000 Jun 22;405(6789):882.