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. 2000 May 13;320(7245):1339.
Registering clinical trials
Register of clinical trials in children must be set up
Editor—Tonks's paper1 and other efforts to boost registration of new clinical trials2 should be supported. Registration of clinical trials would benefit evidence based health care and freedom of information and, more importantly, would benefit patients, particularly children.
Randomised controlled trials aimed at meeting the requirements of regulatory agencies are seldom carried out in paediatric patients, and many children thus receive drugs that do not have labelling for paediatric use.3 Furthermore, there is an imbalance in the distribution of efforts and resources. Systematic studies (and reviews) have focused mainly on a few childhood illnesses such as asthma, otitis media, and respiratory tract infections—as found by consulting the Cochrane Library.
This longstanding, underprivileged position of children underlines the need for further approaches aimed at promoting the rational use of drugs in paediatric patients. Over the past 20 years the number and diversity of databases available to the biomedical research community have grown considerably. These resources, including a few that deal with children, range from registries of patient information to datasets of national demographics.
Comparable approaches in gathering and organising information on randomised controlled trials have not been developed.2 Although the need to identify unpublished randomised controlled trials in children was noted long ago,4 no retrospective and prospective registries have been set up. These registries are a useful resource for doctors planning new studies, promote communication and collaboration between researchers, and facilitate patients' (and parents') access to and recruitment into trials.
The European Network for Drug Investigation in Children5 is considering the feasibility of a pan-European register of randomised controlled trials in children. As Tonks points out, it is encountering some barriers (economical, legislative, ethical, and, in particular, cultural) to establishing a collaboration among all members. Nevertheless, we strongly agree with Tonks's statement that registering a clinical trial is “a clinical declaration of intent by those doing the work, and those paying for it.” Registering trials would satisfy the right of children, parents, and their family doctor to have access to all the available evidence, including that on trials in which they might take part.
2.Horton R, Smith R. Time to register randomised trials. BMJ. 1999;319:865–866. doi: 10.1136/bmj.319.7214.865. . (2 October.) [DOI] [PMC free article] [PubMed] [Google Scholar]
3.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. BMJ. 2000;320:79–82. doi: 10.1136/bmj.320.7227.79. . (8 January.) [DOI] [PMC free article] [PubMed] [Google Scholar]
4.Bonati M. Is it time for a registry of clinical trials in pediatrics? J Pediatrics. 1990;116:667. doi: 10.1016/s0022-3476(05)81627-0. [DOI] [PubMed] [Google Scholar]
5.Bonati M, Choonara I, Hoppu K, Pons G, Seyberth H. Closing the gap in drug therapy. Lancet. 1999;353:1625. doi: 10.1016/S0140-6736(05)75752-4. [DOI] [PubMed] [Google Scholar]
BMJ. 2000 May 13;320(7245):1339.
Italian clinical trial registry is kept by pharmacists on local ethical committees
Editor—The debate on registering clinical trials1-1,1-2 and its importance for all interested parties (investigators, government agencies, the pharmaceutical industry, local ethical committees, and patients) is of great relevance in Italy nowadays. Recent legislation has given more power and responsibilities to local ethical committees in terms of approval of protocols and monitoring of studies.1-3
The Italian Society of Hospital Pharmacy (Società Italiana di Farmacia Ospedaliera) proposed to its pharmacists' network involved in local ethical committees that it should keep a registry of all clinical protocols under evaluation by the committees.1-4 The Italian law requires a pharmacist to be appointed ex officio in each local ethical committee,1-3 and the registry was set up in August 1998.
The registry has four objectives: to share information among participating committees on protocols under evaluation at different sites; to give an overall picture of clinical experimentation in Italy; to monitor clinical trials at central and local levels while they are being carried out and after they have ended; and to give local committees the possibility of giving predefined activity reports on their activity.
Data are now available on one year of activity of 20 local ethical committees in different geographical areas in Italy. Information on 625 evaluations corresponding to 452 protocols was collected. One hundred and nine of the protocols were evaluated by two or more local ethical committees. Most were experimental studies evaluating drugs (n=376), sponsored (348), and multicentre (393).
Among drug studies, 226 were phase III studies. A larger proportion of phase I-II studies than phase III studies were not sponsored (22/63 (35%) v 29/226 (13%)) and single centre (18/63 (29%) v 9/226 (4%)). The complete data are available at the society's website (http://www.sifo.it).
Data will be collected via the internet. Access will be password protected and limited to the participating local ethical committees. Data collected through the registry are:
General characteristics of the study (type, title, objectives, coordinating centre, treatments, phase, study design, population, statistics, sponsor)
Local ethical committee's decision (approved/not approved/suspended) and reasons leading to the decision
Study monitoring at local level (first enrolment date, payment, reason for and date of interruption/suspension/ending of the trial in the centre, number of patients enrolled at the end)
Study monitoring at central level (protocol amendments, adverse drug reactions).
We believe that making clinical trials registries into working instruments and a source of information for local ethical committees' activity will contribute to their completeness and their usefulness at national level.
References
1-1.Horton R, Smith R. Time to register randomised trials. BMJ. 1999;319:865–866. doi: 10.1136/bmj.319.7214.865. . (2 October.) [DOI] [PMC free article] [PubMed] [Google Scholar]
1-3.Ministero della Sanità. Guidelines for institution and procedures of ethical committees. Rome: Istituto Poligrafico e Zecca dello Stato; 1998. . (Gazzetta Ufficiale della Repubblica Italiana, Serie Generale No122.) [Google Scholar]
1-4.Rampazzo R, Scroccaro G. Activity of ethic committees in Europe: a survey by ESCP. In: Scroccaro G, Martini N, Delporte JP, Husson C, Walker R, editors. Progress in clinical pharmacy—clinical trials and pharmacoepidemiology. Part 1. Noordwijk, Netherlands: European Society of Clinical Pharmacy; 1994. pp. 21–27. [Google Scholar]
