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Clinical trial registries are being increasingly acknowledged worldwide. We searched for possibly trustworthy online registries that are not already included in the International Clinical Trials Registry Platform to evaluate whether other useful trial data sources exist and whether they could potentially be consulted, since the strategy search within this platform has recently been questioned. Fifty-nine registries were initially identified, and 11 of them fit the criteria applied and were analyzed for quality and usability. Four additional, potentially reliable registries were identified that researchers could exploit in order to obtain a more global view of the issue being investigated.

Purpose: Quality of care is strongly influenced by evidence-based medicine, a large part of which is based on results obtained from clinical trials. If trials are conducted in secret, patient safety is at risk. Several mandates-legal, editorial, financial, and ethical-have tried to influence the disclosure of clinical trials, first by encouraging registration in publicly accessible registers and, second, by calling for the publication of results. Not all these initiatives have reached high rates of compliance, but the succession of national and international events over a few years gave an important boost to information disclosure. This article provides a chronicle of the succession of the events, from the historical calls to the recent EMA policy and WHO statement, and public consultations requested by the NIH, and the HHS, which will inevitably change the international panorama. The path of these new policies is moving towards more supervised clinical research. Individual scientific institutions can also contribute, at the local level, to such an ethical endeavor as is improving research transparency, by disclosing information on the trials coordinated by their own researchers., Results: The way is long and complex, but, if everyone contributes there could be a prompt, worldwide diffusion of the findings of clinical trials, and therefore a more possible evidenced-based medicine.

Objective: Clinical trials registries are important for guaranteeing trustworthy scientific knowledge. Despite international initiatives promoting trial registration, however, complete and high quality disclosure of trial information in such registries is not routine. The role of registries in also increasing transparency is fundamental, and these databases could be contemplated by research organizations, even at more local levels., Methods: A rare initiative was set up at the IRCCS-Mario Negri Institute for Pharmacological Research in Milan in order to make the institute's ongoing research accessible to anyone., Results: The register currently includes 112 studies in which the institute participates., Conclusions: Work still needs to be done to improve the registry, but it is up and functional. Could, or should, such registries be routine for all scientific institutions?

Objectives: To determine how many online clinical trial registers include paediatric trial data, how much information is provided, ease of searching for paediatric trials and the accessibility of paediatric trial data in general., Methods: Medline and Google were searched for mention of clinical trial registers in July 2008. All registers considered to be eligible were evaluated for trial information provided, search options available, and number of trials, both total and paediatric. A meta-analytic weighted average of the presence of paediatric trials was calculated and compared to the percentage of published paediatric trial articles in Medline. The paediatric trials in the registers were searched for in the World Health Organization's International Clinical Trials Registry Platform (ICTRP). All online, freely accessible registers including ongoing trials on different drugs or therapeutic areas, were eligible for review., Results: Twelve registers were included in the review. All except one provided detailed trial data, while search options varied between registers: seven provided free-text searching, two listed their trials by condition, two provided elaborate search options (age group, condition, study purpose, etc) and one simply listed its trials. Nine of the 12 registers' search facilities made it possible to search for paediatric trials, and these were analysed further: the percentage of paediatric trials in the single registers ranged from 4.8 to 33.3%, and the weighted average was 15% (95% confidence interval 8.2-21.8). The percentage of published, paediatric trial articles was 25%. Of the paediatric trials also searched for in the ICTRP, 66% were found., Conclusions: Great difficulty was found in retrieving paediatric trials due to the limited and inadequate search functions of the registers reviewed but, in general, the registers seem to represent fewer paediatric trials than those reported in the literature. The ICTRP portal is important for trial accessibility, but it is still in an initial phase and far from representative of the global research situation, especially in the field of paediatrics.

Aim: To evaluate the current paediatric therapeutic research situation in Europe with respect to paediatric needs and drug therapies., Methods: Data from ongoing and published paediatric drug therapy trials from 2004 to 2007 were evaluated and compared to the European Medicines Agency (EMEA) priority list for studies on paediatric medicinal products. Ongoing trial data from the DEC-net paediatric trial register and published trials from two biomedical databases were used., Results: In all, 379 trials from the 27 European Union (EU) countries were found (most common country: Italy, 18.2%). The major disease area covered was 'infectious and parasitic diseases' (21.4%). Only four of 25 EMEA priority conditions were addressed, the most common were 'malignant diseases' (18.2% of trials) and 'asthma' (3.2%). A subset of 190 published trials, representing the same four countries that participated in DEC-net (France, Italy, Spain and United Kingdom), was compared to the register's 257 ongoing trials. Some significant differences in disease areas covered were found. Concerning the EMEA priority conditions, the ongoing research addressed more of them., Conclusion: Paediatric research is being carried out in Europe, but this study found a general lack of overlap between therapeutic needs and research. The Paediatric Regulation will hopefully lead to research that is more focused on children's needs.

Objective: To describe the results and conclusions of DEC-net, an international, publicly available register of paediatric drug therapy clinical trials, and to assess which paediatric health areas are covered by research and by which trial types., Methods: The contents of the register, which was set up by four groups (Italy, UK, France, Spain) who searched for paediatric trials and collected data between 2004-2006, were analysed. The disease areas reflected were compared with those covered by published trials and Burden of Disease (BD) data., Results: In all, 257 trial records were analysed, 86 of which were entered by the Italian partner, 84 by the UK partner, 56 by the French partner and 31 by the Spanish partner. Spain entered the majority of multinational trials, while the UK had the majority of single-centre national trials. Most trials were experimental (79%), and the most commonly represented diseases were neoplasms (14% trials). In all, 28% were double-blind randomised controlled trials (RCTs). The most common disease areas addressed in the 257 trials were similar to the published trials' areas. In contrast, the primary research area was low on the BD list., Conclusions: DEC-net has demonstrated that international research efforts exist, even for paediatrics, although there may be an imbalance between national and multinational studies and a limited approach to double-blind RCTs. Recent initiatives will increase the number of children participating in research, and European legislation will require prospective registration. Paediatric research priorities must be better defined, however, and this can be done by registering research and making the information available to all relevant actors.

Clinical trials have a fundamental role in promoting an evidence based use of drugs in adults and in children. However, it is often difficult to identify the few paediatric studies carried out and to thus implement knowledge derived from them. Furthermore, studies that are stopped prematurely or that have insignificant or negative results often remain unpublished, leading to duplication of effort by researchers, waste of resources and concealment of potentially toxic risks. The European Community decided to support the development of a European register of clinical trials in children as part of the Fifth Framework Thematic Programme "Quality of Life" in 2002. The project DEC-net is coordinated by the Laboratory of Mother and Child Health of the Mario Negri Institute for Pharmaceutical Research in Milan and currently involves members of four countries; France, Italy, Spain and the United Kingdom. It is unique in that it is the first population oriented clinical trial register. Such a register represents a useful source for planning new studies, promoting communications and collaborations between researchers, facilitating patient access and recruitment into trials, preventing trial duplication and inappropriate funding and identifying the therapeutic needs of children that remain neglected. It will also allow for active monitoring of new or evolved knowledge of drug therapies.

Background: The need to register a clinical trial in a public database has been widely discussed in the last few years. Several general clinical trial registers have been developed, but none are dedicated to children. A web-based register of trials on drug therapy in children was therefore developed., Purpose: The general objective of the project, called DEC-NET (European register of clinical trials on medicines for children - drug evaluation in children) and supported by the European Community, is to provide the scientific community with a flexible tool for promoting communication and collaboration among researchers, disseminating clinical trial results and facilitating patient access and recruitment to trials., Methods: We identified a set of trial data to be collected, including general trial information, recruitment information, eligibility criteria, clinical trial characteristics, location and contact information, study drugs, study sponsor and results. The system was set up to allow authorized users (working in Italy, Spain, France and UK) to enter, handle and monitor the trial information. Medical data dictionaries (ie, ICD-9 and ATC) were used in order to make the data-entry and the search and data analysis procedures easier. A multilingual approach in data handling and presentation made accessing trial information in English and in the language of the country where the study is located feasible. Search and browsing tools were set up to allow investigators, researchers, and citizens to freely search and browse the entire register and access the details of trials meeting the search criteria., Results: The DEC-net register (http://www.dec-net.org) was opened for trial notification and consultation., Limitations: DEC-net currently involves four European countries and is a pilot project., Conclusions: It is hoped that what has been achieved so far represents only the beginning of a long-term project, and the next step will be to extend the register's use to other European countries.

Children, as well as adults, can be subjects of clinical trials. An overview of the history and development of clinical experimentation through the main scientific publications is briefly outlined. A chart of children rights is also presented and discussed. Children's rights range from the right of being included in clinical trials to the right of being participants in a research that complies, without being overwhelmed, with formal rules. The maximum respect for the child is assumed if innovative questions are asked and independence and autonomy of judgement of researches are observed.

To define and evaluate the attention devoted to drug use in children rather than just review existing reviews, the present attempt is to seek out the primary sources of information in the hope that this effort would not only yield more reliable data, but would also provide an opportunity for reconsidering methodological problems which are possibly even more important. An English-language literature search for drug use in children from 1988 was conducted on two databases and a manual search was made of the literature, with a check of references quoted in main original articles, reviews and textbooks. The review was then organized in two main sections: an overall evaluation of the recent literature concerning drug use in children; the epidemiological profile of drug exposure as described cumulatively by the drug-utilization studies. A substantial lack of systematic attention to this area of drug epidemiology was found: drug use in the children is a 'hidden' reality in the literature; the wealth of methodologic developments that have taken place in the general field of drug use monitoring has scantly reached children. Children can be considered still "methodologic orphans" with respect to the transferable knowledge on the benefit/risk profile of therapies they receive. A network has to be developed to monitor clinical problems, including drug use, as part of an "audit" of the overall management of children.