LEADING ARTICLE 559 Legislation American trials which were being Arch Dis Child: first published as 10.1136/adc.2004.064378 on 20 May 2005. Downloaded from ....................................................................................... submitted to the Food and Drug Administration (FDA)). An additional development in Europe Should paediatricians support the is that all new clinical trials involving medicines need to be registered with the European Paediatric Clinical Trials EMEA. This legislation affects both the pharmaceutical industry and academic Register? investigators who carry out independent research. What is not known at this H M Sammons, C Naylor, I Choonara, C Pandolfini, M Bonati stage is how much of the information available on the European Clinical Trials ................................................................................... Register will be accessible to academia, health professionals, and the public. A Ensuring its success will help improve the use of medicines register that is only accessible to the in children regulatory authorities will not benefit children. he importance of clinical trials in receive the safest and most effective children in providing a scientific treatment, health professionals need the DO PAEDIATRIC CLINICAL TRIALS Tevidence base for drug therapy is complete information. The existence of NEED A SEPARATE REGISTER? accepted by health professionals, regu- the European Paediatric Clinical Trials Health professionals who work with latory authorities, the pharmaceutical Register does not ensure publication.6 It children are well aware that many industry, and the parents of children. does, however, alert health professionals medicines used in paediatric patients Legislation in the USA alongside gov- to the fact that a clinical trial has been are either unlicensed or used off label.11 ernment investment in research has completed. This then allows researchers It is well recognised that drug toxicity in resulted in a significant increase in who are carrying out systematic reviews children is different to that in adults.12 paediatric clinical trials in North to contact the investigators directly and Additionally, the design of paediatric America.1 European legislation is cur- obtain unpublished data. The existence clinical trials is different to that in rently being proposed that will provide a of a register also prevents duplication by adults, where healthy volunteers can financial incentive to the pharmaceuti- investigators and encourages collabora- be used.13 Recruitment to paediatric cal industry to study medicines in tion. Additionally, it allows sponsors clinical trials involves patients and there- Europe. The proposal has been prepared (medical charities, Department of fore is usually slower, requiring more by the European Commission following Health) to ensure that duplicate studies emphasis on safety than corresponding extensive consultation. Within the UK are not funded. studies in adults.14 For these reasons, the establishment of a Medicines for there is a clear need for a separate register Children Research Network will hope- Pharmaceutical industry of paediatric clinical trials. fully also ensure that more clinical trials Concern has been raised that clinical are performed in paediatric patients of trials which produce negative results are EUROPEAN PAEDIATRIC CLINICAL all ages. deliberately suppressed by the pharma- TRIALS REGISTER http://adc.bmj.com/ ceutical industry.78 In the UK, the There is currently only one clinical trials REGISTRATION OF CLINICAL Association of the British Pharma- register that exclusively deals with TRIALS ceutical Industry (ABPI) has established paediatric clinical trials. This register There is increasing recognition that as a Clinical Trial Register. This register, was established with funding from the well as performing clinical trials, regis- however, is only voluntary and not all European Community.6 The project tration is essential.23 Many completed companies are supporting it. It is only commenced in January 2003 and cur- clinical trials are never published. A public pressure or legislation that will rently involves four countries: Italy, on September 27, 2021 by guest. Protected copyright. group of researchers in North America ensure that the pharmaceutical industry France, Spain, and the UK. The lead have studied the publication of clinical fully supports the concept of registration centre is in Milan and the register went trials that had been presented as of clinical trials. live on 1 July 2004.15 It can be accessed abstracts at the Society for Pediatric through the website www.dec-net.org. Research. They found that 28% of Compulsory registration The register is freely available to both abstracts were subsequently not pub- Several leading adult medical journals health professionals and the public. lished.4 This however may have been an have declared that clinical trials sub- Trial information is available in two underestimate as they relied on the mitted for publication will need to have different formats, a simple one aimed at return of questionnaires from authors been registered in order for their find- parents and the public and a more who had presented the abstracts. A ings to be published.910 This is a advanced one aimed at health profes- British study of the publication rate welcome step and will ensure that sionals. Users are, however, free to following presentation at two national clinical trials registers are used. The choose whether they obtain the simple meetings found that 22% and 49% of the International Committee of Medical or advanced information. Information presentations were subsequently not Journal Editors (ICMJE) has not advo- listed in the register is as follows: published as full papers.5 In the majority cated a particular register but has of cases the authors did not submit their suggested that the register sponsored N Title of protocol findings for publication. by the United States National Library of N Status of the clinical trial The lack of publication of completed Medicine (www.clinicaltrials.gov) meets N Disease 9 clinical trials adversely affects the evi- all their necessary requirements. N Age and sex of patients being studied dence base on which decisions regard- Concerns have, however, been expressed ing choice of drugs and dosage in in that this register is quite restrictive as N Aim of the study relation to efficacy and toxicity are to which trials can be registered10 (the N Contact details for lead investigator made. In order to ensure that children register was primarily designed for N Participating centres/countries. www.archdischild.com 560 LEADING ARTICLE The advanced view contains more Within the UK there has been con- opportunity. Paed Perinat Drug Ther Arch Dis Child: first published as 10.1136/adc.2004.064378 on 20 May 2005. Downloaded from 2000;4:71–4. details and includes administrative siderable support for the register from 2 Dickersin K, Rennie D. Registering clinical trials. information about the trial (local pro- the Royal College of Paediatrics and JAMA 2003;290:516–22. tocol number, EUDRACT number, Child Health, the Neonatal and 3 Steinbrook R. Public registration of clinical trials. N Engl J Med 2004;351:315–17. ISRCTN number). Also included are Paediatric Pharmacists Group, and the 4 Hartling L, Craig WR, Russell K, et al. Factors the following: ABPI. Over 40 of the clinical trials on the influencing the publication of randomized register are studies from the UK. More controlled trials in child health research. Arch Pediatr Adolesc Med 2004;158:983–7. N Name of the drug than 20 different academic units and 5 Riordan FAI. Do presenters to paediatric meetings N Type of trial (therapeutic efficacy, NHS hospitals have already provided get their work published? Arch Dis Child information on clinical trials that they 2000;83:524–6. pharmacokinetic, safety/toxicity) 6 Pandolfini C, Bonati M, Sammons H, et al. A are involved in. Ensuring the success of N Inclusion criteria European clinical trials registry for children. Paed the only Paediatric Clinical Trials Perinat Drug Ther 2003;5:98–100. N Exclusion criteria. Register worldwide will help improve 7 Herxheimer A, Mintzes B. Antidepressants and adverse effects in young patients: uncovering the the use of medicines in children. evidence. CMAJ 2004;170:487–9. Since the official launch of the register, Arch Dis Child 2005;90:559–560. 8 Whittington CJ, Kendall T, Fonagy P, et al. the website has seen an average of 400– Selective serotonin reuptake inhibitors in doi: 10.1136/adc.2004.062836 500 hits each month. As of January childhood depression: systematic review of published versus unpublished data. Lancet 2005 the website had had over 3700 ...................... 2004;363:1341–5. visits. This illustrates the importance of Authors’ affiliations 9 De Angelis C, Drazen JM, Frizelle FA, et al. ensuring that the website is user Clinical trial registration: a statement from the H M Sammons, C Naylor, I Choonara, International Committee of Medical Journal friendly. Academic Division of Child Health, The Editors. N Engl J Med 2004;351:1250–1. The register currently contains details Medical School, University of Nottingham, 10 Abbasi K. Compulsory registration of clinical of over 60 clinical trials. These range Derbyshire Children’s Hospital, Derby, UK trials. BMJ 2004;329:637–8. 11 Turner S, Longworth A, Nunn AJ, et al. from double blind randomised con- C Pandolfini, M Bonati, Mario Negri Institute, Unlicensed drug use on paediatric wards.