Search

Item does not contain fulltext

1 mei 2010, Contains fulltext : 89113.pdf (publisher's version ) (Open Access), PURPOSE: To provide an overview of and discuss newly authorised medicines with an improved efficacy. METHODS: This analysis focussed on new medicines with an improved efficacy based on the results of randomised active control trials. Information on comparative efficacy was obtained from the European Medicines Agency European Public Assessment Reports. RESULTS: Between 1999 and 2005 we identified 122 new medicines with a new active substance. Of these, 13 (10%) were shown to be superior to already available medicines in terms a statistically significant difference in primary clinical endpoints. CONCLUSIONS: A proven advantage in efficacy at an early stage of drug development is the exception rather than the rule. The absence of evidence demonstrating differences between medicines does not necessarily mean that there are no actual differences. Optimal pharmacotherapy would benefit from more comparative research in the development of new medicines. The results of comparative trials need to be critically evaluated for their specific value in clinical practice. To this end, prescription data may be helpful.

Item does not contain fulltext, BACKGROUND: When choosing the active control group in a randomized trial, it is important to maintain standard treatment for the therapeutic indication for which a medicine is studied. This choice is relevant not only for demonstrating the efficacy and safety of a new drug, but also for assessing its place in therapy in comparison with existing medicines. Comparative information is important for decisions on prescribing and reimbursement. However, choosing the most suitable comparator is difficult when recommendations on drugs of first choice vary depending on clinical settings and times. OBJECTIVE: To evaluate the choice of comparator in premarketing randomized active control trials (RaCTs) in comparison with recommendations for standard treatment. METHODS: We evaluated drugs that were authorized for use in the European Union market between 1999 and 2005. Information on active comparators in RaCTs was extracted from the European Public Assessment Reports and information on recommendations regarding standard treatment was retrieved from the annual editions of the Dutch reference book on pharmacotherapy. Data on prescribing and indications at the time of authorization and 3 years before authorization were included. The comparator was considered to be in line with standard treatment if there was a similarity in both active substance or therapeutic class and the dosage. RESULTS: For 58 new medications identified, treatment in the active control group was in line with the recommended standard treatment in 108 of 153 (71%) RaCTs at the time of the drug's authorization; 47 (81%) of the new drugs had been compared with the recommended standard treatment in at least one trial. When dissimilarities occurred, none of the comparators had been recommended as standard treatment 3 years earlier (the supposed time of defining the trials' protocol). CONCLUSIONS: Most comparators in the premarketing RaCTs of new medicines were in line with the recommended standard treatment at the m

Item does not contain fulltext, WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT: Randomized active control trials are used by health care professionals and reimbursement authorities for the assessment of the added value of a new medicine. Failing to publish the results of clinical trials limits making an evidence based assessment and conducting systematic reviews. WHAT THIS STUDY ADDS: About one-third of the comparative trials used in the authorization process are published at the moment of market authorization and about four out of five within 2 or 3 years. Most of the rest remain unpublished. Unpublished trials contain information regarding a different therapeutic use or a different comparator of the same medicine and, in some cases, have influenced the risk : benefit assessment of the registration authorities. A standardized public registration of results of the main premarketing trials is advocated to fill the publication gap. AIMS: To determine the time-lag between the EU authorization of new medicines and the publications of the main randomized active control trials (RaCTs) used in the authorization process and to compare unpublished with published RaCTs of the same medicine. METHODS: All RaCTs for new medicines with a new active substance, authorized between 1999 and 2003, were extracted from the European Public Assessment Reports (EPAR). Information about the publication status of RaCTs was obtained from the MEDLINE and EMBASE databases. RESULTS: We identified 116 RaCTs for 42 new medicines; 28% of the RaCTs had been published at the moment of market authorization, 59% after 1 year, 78% after 2 and 83% after 3 years. Most of the rest of the studies remained unpublished after 3 years of follow-up. Unpublished RaCTs differed from published trials of the same medicine especially regarding therapeutic use and/or comparator. In some cases unpublished trials have influenced the risk : benefit assessment of the registration authorities. CONCLUSIONS: Most of the main RaCTs, relevant for assessing the ad

Item does not contain fulltext, AIMS: To investigate the availability of information about premarketing randomized active-control trials (RaCTs) involving medicines with a new active substance at the moment of market authorization in the European Union. METHODS: Information was obtained from the EMEA European Public Assessment Reports and the MEDLINE and EMBASE databases. RESULTS: Between 1999 and 2005, 48% of recently approved medicines (n = 122) had been studied in comparison with existing medicines at the moment of market authorization. About one-third of these trials were published and publicly available at that moment. CONCLUSIONS: For most new medicines evidence-based assessment of the (added) therapeutic value is not really possible at the moment of market authorization.

RU Radboud Universiteit Nijmegen, 17 maart 2006, Promotores : Ven, J.A. van der, Gribnau, F.W.J., Contains fulltext : mmubn000001_451919017.pdf (publisher's version ) (Closed access)

Item does not contain fulltext

KUN, 11 juni 2003, Promotores : Hekster, Y.A., Gribnau, F.W.J., Edwards, I.R. Co-promotor : Meyboom, R.H.B., Item does not contain fulltext

Item does not contain fulltext

Item does not contain fulltext

Item does not contain fulltext

Item does not contain fulltext

KUNijmegen, 25 juni 1999, Promotores : Hoefnagels, W.H.L., Gribnau, F.W.J., Item does not contain fulltext

Item does not contain fulltext

Item does not contain fulltext

KU Nijmegen, 13 oktober 1998, Promotores : Gribnau, F.W.J., Hekster, Y.A., Contains fulltext : mmubn000001_270541349.pdf (publisher's version ) (Open Access)

Item does not contain fulltext

Universiteit Nijmegen, 13 oktober 1998, Promotores : Gribnau, F.W.J., Hekster, Y.A., Item does not contain fulltext

Item does not contain fulltext

Item does not contain fulltext

Item does not contain fulltext

In: Abstracts of Papers and Posters; Drug Utilization Research and Pharmacoepidemiology Meeting, Utecht (The Netherlands), 19 May 1995

Katholieke Universiteit Nijmegen, 15 november 1995, Promotores : Gribnau, F.W.J., Noordhoek, J., Item does not contain fulltext