Rapid Responses to:
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Rapid Responses: Rapid Responses published:
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![[Read Rapid Response]](/icons/misc/sectionDOWN.gif)
Power of Scientific Journals
- Stefan W. Krause (14 December 2002)
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Transparency of clinical trials: the patient’s perspectives
- Nicki On (28 December 2002)
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Something is finally moving, at least in the paediatric field...
- Maurizio Bonati, Chiara Pandolfini*, Imti Choonara**, Evelyne Jacqz-Aigrain***, Josep Arnau***. *IRFMN, Milan, I. **University of Nottingham, Derby, UK. ***Hopital Robert DEBRE, Paris, F. ****Fundacio Institut Catala de Farmacologia, Barcelona, E. (29 December 2002)
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The Principal Principle
- Jonathan R. Benger (31 December 2002)
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An unanticipated effect of clinical trial registration
- David L. Hahn (2 November 2007)
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Stefan W. Krause, attendant University Hopital, Dept. Hematology/Oncology, 93042 Regensburg, Germany
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Lobbying is one part, but the power of medical journals should not be underestimated, since the wish to publish is the driving force at least of academic personnel involved in clinical trials. If only 20 or 30 of the most prestigous medical journals announced that they will not publish the results of a clinical trial in the future, unless this trial has been registered before inclusion of patients, the completenes of trial registries would increase rapidly. Competing interests: None declared |
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Nicki On, Founder DA17 5BA
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Dear Ms Tonks I am writing in response to your article “A clinical trials register for Europe”. In an attempt to make clinical trials more transparent to the public and researchers, a patient friendly clinical trial portal website www.drugsontrial.com was recently launched, which acts as an information hub for the clinical trial community. Our current remit is to list trials in UK then later to expand to trials within the EU. Our objective is to enable potential patients to learn more about available trials and clinical trial background, which would help them to make informed choices about clinical trial participation. There has been an imbalance in terms of knowledge in clinical trials between investigators and potential patients. Often, broaching by the investigators can make the patients feel unease, which may lead to a less informed choice. Indeed, the FDA has recently assessed the role of internet trials in USA and concluded that this strategy led to increased informed consent. DrugsOnTrial is NOT a clinical trial registry that keeps records of all trials. Our mission is to address the point you mentioned in your article “In an ideal world people would declare their trials for the greater good, to help with recruitment, and to make their work more visible”. This website has been live for 3 months and received lots of viewers who even registered to be informed of upcoming trials. I hope the medical professions involved in clinical trials would find DrugsOnTrial.com helpful like the public at large. Dr Nicki On. PhD, MBA, MRPharmS. Competing interests: None declared |
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Maurizio Bonati, Laboratory for Mother and Child Health, "Mario Negri" Research Institute Via Eritrea 62, 20157 Milan, Italy, Chiara Pandolfini*, Imti Choonara**, Evelyne Jacqz-Aigrain***, Josep Arnau***. *IRFMN, Milan, I. **University of Nottingham, Derby, UK. ***Hopital Robert DEBRE, Paris, F. ****Fundacio Institut Catala de Farmacologia, Barcelona, E.
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In support of Tonk’s editorial, "A clinical trials register for Europe" published in the December 7 issue, we would like to add that the longstanding, underprivileged position of children throughout Europe with respect to medicine calls for strategies aimed at the promotion of the rational use of drugs in paediatric patients. Clinical trials have a fundamental role in obtaining this, since they are the key to distinguishing useful from harmful treatments. However, it is difficult to identify the already insufficient (in number and, at times, in method) paediatric studies carried out and to thus implement the knowledge derived from them. The development of a drug therapy trials registry specific to the paediatric field would therefore be valuable, but, despite the remarkable efforts made to create numerous, diverse databases addressing the needs of the biomedical research community in the past few years, none have involved such a registry. A registry of completed and ongoing clinical trials in children would be a useful resource for planning new studies, promoting communication and collaboration among 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 would also allow for active monitoring of new or evolved knowledge of drug therapies. At the conclusion of the Fifth Framework Programme, the European Community decided to fund the development of a European register of clinical trials in children whose aim is to create an online registry that will collect essential data on paediatric clinical trials conducted in European member states, and will monitor the outcome of the studies (results, conclusions and publications). A network has already begun to materialise, characterised by different, complementary clinical backgrounds and research experiences to facilitate the creation of a clinical trials registry. The members will identify planned and ongoing trials through communication with ethical review boards, national associations of paediatricians, pharmaceutical companies, etc, and the data will then be collected into one database. Members will be responsible for monitoring progress in their country and in countries allocated to them in order to keep the register up to date. The register will be put up on the internet, with a friendly interface so that trial data will be available to all. Competing interests: None declared |
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Jonathan R. Benger, Registrar in Emergency Medicine Royal United Hospital, Bath, UK. BA1 3NG
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Editor, I enjoyed reading the editorial regarding a clinical trials register for Europe, and support the principles outlined by Alison Tonks,(1) I was, however, surprised to note that amongst the core items proposed for trial registration (listed in the article's box) are the contact details for the "principle investigator". Whilst it seems only sensible that a trial's principal investigator should be a person of principle, how would this be determined in practice? Or has the BMJ joined the increasing number of organisations that seem unable to distinguish between the words principal (first in order of importance)and principle (fundamental truth or proposition serving as the foundation for belief or action)? 1. Tonks A. A clinical trials register for Europe. BMJ 2002;325:1314- 5. Competing interests: None declared |
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David L. Hahn, Family physician and clinical researcher Dean East Clinic, Madison, Wisconsin 53716 USA
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Based on positive pilot results [1] we are currently enrolling patients into a nationwide (US) practice-based research network (PBRN) trial of the effectiveness of azithromycin as adjunctive treatment for adult asthma (AZMATICS: www.clinicaltrials.gov/NCT 00266851). The original protocol anticipated enrolling patients from the participating PBRN practices, whereas we have now enrolled additional eligible subjects who contacted the principal investigator (PI) after having searched the clinicaltrials.gov website for asthma studies. A second unanticipated source of subjects has been www.asthmastory.com, a website giving a patient testimonial of a dramatic response to azithromycin treatment. According to a non-systematic query from the PI, both websites could be accessed from Google searches using such terms as “cure” and “asthma.” Several patients, particularly those exposed to the compelling story related on the latter website, have declined randomization in favor of receipt of open-label treatment from the personal physician. We have therefore added an observational arm to AZMATICS for this group that we suspect have more severe asthma and a greater likelihood of response. For our trial, patient self-referral via Internet has been an unanticipated resource for study recruitment. 1. Hahn DL, Plane MB, Mahdi OS, Byrne GI. Secondary outcomes of a pilot randomized trial of azithromycin treatment for asthma. PLoS Clin Trials 2006;1(2):e11 DOI: 10.1371/journal.pctr0010011. Competing interests: None declared |
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