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1. Assessment of outcome in ankylosing spondylitis: an extended radiographic scoring system

Author

Creemers, M.C.W., Franssen, M.J.A.M., Van t'Hof, M.A., Gribnau, F.W.J., Van de Putte, L.B.A., and Van Riel, P.L.C.M.

Subjects
Outcome and process assessment (Health Care) -- Methods, Outcome and process assessment (Health Care) -- Research, Radiography -- Usage, Ankylosing spondylitis -- Development and progression, Health
Published
2005

2. Diuretic use and withdrawal in ambulatory elderly

Author

Kraaij, D.J.W. van, Jansen, R.W.M.M., Gier, J.J. de, Gribnau, F.W.J., and Hoefnagels, W.H.L.

Subjects
Effecten en lotgevallen van geneesmiddelen in nier en bloedvaten, Effects and kinetics of drugs in kidney and blood vessels
Abstract

Item does not contain fulltext 5 p.

Published
1998

4. Gap in publication of comparative information on new medicines

Author

van Luijn, J.C.F., Stolk, P., Gribnau, F.W.J., Leufkens, H.G.M., Population-based studies of drug treatment: from molecule to patient outcomes, and Dep Farmaceutische wetenschappen

Subjects
Ziekenhuisstructuur en organisatie van de gezondheidszorg, Epidemiology, Farmacie(FARM), Public Health, Biomedische technologie en medicijnen
Published
2008

5. Availability of comparative trials for the assessment of new medicines in the European Union at the moment of market authorization

Author

van Luijn, J.C.F., Gribnau, F.W.J., Leufkens, H.G.M., Population-based studies of drug treatment: from molecule to patient outcomes, and Dep Farmaceutische wetenschappen

Subjects
Farmacie/Biofarmaceutische wetenschappen (FARM), Ziekenhuisstructuur en organisatie van de gezondheidszorg, Epidemiology, Farmacie(FARM), Public Health, Biomedische technologie en medicijnen
Published
2007

7. Superior efficacy of new medicines?

Author

Luijn, J.C.F. van, Gribnau, F.W.J., Leufkens, H.G.M., Luijn, J.C.F. van, Gribnau, F.W.J., and Leufkens, H.G.M.

Abstract

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.

Published
2010

8. Comparative information on new medicines : availability, quality and usage

Author

Pharmacoepidemiology, Population-based studies of drug treatment: from molecule to patient outcomes, Dep Farmaceutische wetenschappen, Gribnau, F.W.J., Leufkens, Bert, van Luijn, J.C.F., Pharmacoepidemiology, Population-based studies of drug treatment: from molecule to patient outcomes, Dep Farmaceutische wetenschappen, Gribnau, F.W.J., Leufkens, Bert, and van Luijn, J.C.F.

Published
2010

9. Choice of comparator in active control trials of new drugs.

Author

Luijn, J.C.F. van, Loenen, A.C. van, Gribnau, F.W.J., Leufkens, H.G.M., Luijn, J.C.F. van, Loenen, A.C. van, Gribnau, F.W.J., and Leufkens, H.G.M.

Abstract

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

Published
2008

10. Gap in publication of comparative information on new medicines

Author

Population-based studies of drug treatment: from molecule to patient outcomes, Dep Farmaceutische wetenschappen, van Luijn, J.C.F., Stolk, P., Gribnau, F.W.J., Leufkens, H.G.M., Population-based studies of drug treatment: from molecule to patient outcomes, Dep Farmaceutische wetenschappen, van Luijn, J.C.F., Stolk, P., Gribnau, F.W.J., and Leufkens, H.G.M.

Published
2008

11. Gap in publication of comparative information on new medicines.

Author

Luijn, J.C.F. van, Stolk, P., Gribnau, F.W.J., Leufkens, H.G.M., Luijn, J.C.F. van, Stolk, P., Gribnau, F.W.J., and Leufkens, H.G.M.

Abstract

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

Published
2008

12. Availability of comparative trials for the assessment of new medicines in the European Union at the moment of market authorization.

Author

Luijn, J.C.F. van, Gribnau, F.W.J., Leufkens, H.G., Luijn, J.C.F. van, Gribnau, F.W.J., and Leufkens, H.G.

Abstract

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.

Published
2007

14. Diuretic usage and withdrawal patterns in a Dutch geriatric patient population

Author

Kraaij, D.J.W. van, Jansen, R.W.M.M., Bruijns, E., Gribnau, F.W.J., and Hoefnagels, W.H.L.

Subjects
Pharmacology, Clinical, algemeen [Geneeskunde], Pharmacology, Clinical, Gezondheid, Bescherming en bevordering van de menselijke gezondheid, Geneeskunde: algemeen, Medical sciences, GeneralLiterature_REFERENCE(e.g.,dictionaries,encyclopedias,glossaries), Financial Economics, Medische Wetenschappen
Abstract

Contains fulltext : 25665___.PDF (Publisher’s version ) (Open Access)

Published
1997

15. Spiritual Care in a Hospital Setting. An Empirical-theological Exploration

Author

Ven, J.A. van der, Gribnau, F.W.J., Smeets, W., Ven, J.A. van der, Gribnau, F.W.J., and Smeets, W.

Abstract

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)

Published
2006

17. Disease activity in ankylosing spondylitis: selection of a core set of variables and a first step in the development of a disease activity score

Author

Creemers, M.C.W., Hof, M.A. van 't, Franssen, M.J.A.M., Putte, L.B.A. van de, Gribnau, F.W.J., and Riel, P.L.C.M. van

Subjects
Pharmacotherapy of rheumatic diseases, Farmacotherapie van reumatische aandoeningen, OVERIG ONDERZOEK MIES, GeneralLiterature_REFERENCE(e.g.,dictionaries,encyclopedias,glossaries)
Abstract

Contains fulltext : 23722.PDF (Publisher’s version ) (Open Access)

Published
1996

18. Methotrexate in severe ankylosing spondylitis: an open study

Author

Creemers, M.C.W., Franssen, M.J.A.M., Putte, L.B.A. van de, Gribnau, F.W.J., and Riel, P.L.C.M. van

Subjects
Piroxicambetacyclodextrin versus naproxen in ankylosing spondylitis, GeneralLiterature_REFERENCE(e.g.,dictionaries,encyclopedias,glossaries), Vergelijking van Piroxicambetacyclodextrine en naproxen in de behandeling van patiënten met de ziekte van Bechterew
Abstract

Contains fulltext : 20642___.PDF (Publisher’s version ) (Open Access)

Published
1995

19. Seeing and observing in international pharmacovivigilance.

Author

Hekster, Y.A., Gribnau, F.W.J., Edwards, I.R., Meyboom, R.H.B., Lindquist, A.M., Hekster, Y.A., Gribnau, F.W.J., Edwards, I.R., Meyboom, R.H.B., and Lindquist, A.M.

Abstract

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

Published
2003

24. Diuretic use and withdrawal in elderly patients

Author

Hoefnagels, W.H.L., Gribnau, F.W.J., Kraaij, D.J.W. van, Hoefnagels, W.H.L., Gribnau, F.W.J., and Kraaij, D.J.W. van

Abstract

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

Published
1999

25. Pharmacovigilance in perspective

Author

Meyboom, R.H.B., Egberts, A.C.G., Gribnau, F.W.J., Hekster, Y.A., Meyboom, R.H.B., Egberts, A.C.G., Gribnau, F.W.J., and Hekster, Y.A.

Abstract

Item does not contain fulltext

Published
1999

28. Detecting adverse drug reactions

Author

Gribnau, F.W.J., Hekster, Y.A., Meyboom, R.H.B., Gribnau, F.W.J., Hekster, Y.A., and Meyboom, R.H.B.

Abstract

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

Published
1998

29. Mechanisms of drug transfer across the human placenta

Author

Aa, E.M. van der, Copius Peereboom-Stegeman, J.H.J., Noordhoek, J., Gribnau, F.W.J., Russel, F.G.M., Aa, E.M. van der, Copius Peereboom-Stegeman, J.H.J., Noordhoek, J., Gribnau, F.W.J., and Russel, F.G.M.

Abstract

Item does not contain fulltext

Published
1998

32. Principles of signal detection in pharmacovigilance

Author

Meyboom, R.H.B., Egberts, A.C.G., Edwards, I.R., Hekster, Y.A., Koning, F.H.P. de, Gribnau, F.W.J., Meyboom, R.H.B., Egberts, A.C.G., Edwards, I.R., Hekster, Y.A., Koning, F.H.P. de, and Gribnau, F.W.J.

Abstract

Item does not contain fulltext

Published
1997

39. Diuretic misuse and complications of congestive heart failure

Author

Heerdink, E.R. (Eibert), Leufkens, H.G.M. (Hubert), Stricker, B.H.Ch. (Bruno), Gribnau, F.W.J., Urquhart, J. (John), Heerdink, E.R. (Eibert), Leufkens, H.G.M. (Hubert), Stricker, B.H.Ch. (Bruno), Gribnau, F.W.J., and Urquhart, J. (John)

Abstract

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

Published
1995

40. Drug transport and drug-nutrient interactions in the human placenta

Author

Gribnau, F.W.J., Noordhoek, J., Aa, E.M. van der, Gribnau, F.W.J., Noordhoek, J., and Aa, E.M. van der

Abstract

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

Published
1995

41. Geneesmiddelen en ouder worden

Author

Bezooijen, C.F.A., Gier, J.J. de, Goedhard, W.J.A., Gribnau, F.W.J., Jonkers, J.R., Knook, D.L., Korst, J.K. van der, Offerhaus, L., Schouten, J., Zwieten, P.A. van, and Instituut voor experimentele gerontologie TNO

Subjects
Biology
Published
1980

43. Influence of non-steroidal anti-inflammatory drugs on diuretic treatment of mild to moderate essential hypertension.

Author

Koopmans, P.P., Thien, T.H., and Gribnau, F.W.J.

Subjects
NONSTEROIDAL anti-inflammatory agents, THERAPEUTICS, HYPERTENSION
Abstract

Examines the influence of non-steroidal anti-inflammatory drugs on diuretic treatment of hypertension. Increase in blood pressure during treatment with indomethacin; Factors contributing to the differences in blood pressure; Level of indomethacin dosage needed.

Published
1984
Full Text
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44. Comparative information on new medicines : availability, quality and usage

Author

van Luijn, J.C.F., Pharmacoepidemiology, Population-based studies of drug treatment: from molecule to patient outcomes, Dep Farmaceutische wetenschappen, Gribnau, F.W.J., and Leufkens, Bert

Subjects
Ziekenhuisstructuur en organisatie van de gezondheidszorg, Epidemiology, Farmacie(FARM), Public Health, Biomedische technologie en medicijnen
Abstract

When a new medicine is marketed, it is important to know how it compares with existing medicines for the same indication. Healthcare professionals and regulators all require this comparative information in order to make decisions on prescribing and reimbursement. Evaluating differences between medicines can best be studied in randomized controlled trials with an existing medicine as the active control group (RaCT). The lack of outcomes of comparative research upon the introduction of a new medicine is regarded as an important problem. However, statistics on the nature and extent of this problem are scarce. The aim of this thesis is to shed light upon this problem by carrying out an evaluation of the availability, quality and the use of the comparative information on new medicines at the moment of market entry. Methods For the studies in the thesis we used the data from the pivotal trials of medicines with a new active substance that were authorized through a Centralised Procedure by the European Commission between 1999 and 2005. Information was extracted from the European Public Assessment Reports (EPARs). Information on publications was obtained from the MEDLINE and EMBASE databases. Results We identified 122 new medicines, of which 58 (48%) had been studied in comparison with an existing medicine. For 33 (27 %) medicines, the results were publicly available as a peer-reviewed publication at the moment of market entry. After two years 78% and after three years 83% of the RaCTs had been published. A new mechanism of action of a new medicine was shown to be a limiting factor in providing comparative information. Of the new medicines, 13 (10%) demonstrated a statistically significant difference in efficacy in comparison with an existing medicine. In a case-study on etanercept, a new medicine without premarketing RaCT, we found that the post-approval trials were unsuitable to answer the demands from clinical practice for more comparative information. Further we found that 47 (81%) new medicines were compared with the recommended standard treatment in at least one trial. We experienced problems interpreting the public data of noninferiority and equivalence trials, as these trials provide insufficient additional information on the comparator in public sources of information on these trials. In an evaluation on decisions on comparative efficacy, for 50 (72%) of the new medicines studied, sufficient premarketing data were available for a clear opinion. However, for only a few (12%) the body of evidence could be ranked at the highest level and for about 40% at the lowest level: the expert opinion. Conclusions The lack of comparative data on one out of two new medicines and the problem of accessibility to the full data of premarketing RaCTs at market entry, represents an obstacle to optimal decision-making on prescribing and reimbursement at the moment when the need is greatest. Though the goal of developing new medicines should be to improve treatment, this is not always apparent from the objectives and outcomes of premarketing research. Optimal pharmacotherapy would benefit from more comparative research in the development of new medicines.

Published
2010

45. Detecting adverse drug reactions

Author

Meyboom, R.H.B., Gribnau, F.W.J., Hekster, Y.A., and Radboud University Nijmegen

Subjects
Effecten en lotgevallen van geneesmiddelen in nier en bloedvaten, Effects and kinetics of drugs in kidney and blood vessels, GeneralLiterature_REFERENCE(e.g.,dictionaries,encyclopedias,glossaries)
Abstract

Contains fulltext : mmubn000001_270541349.pdf (Publisher’s version ) (Open Access) KU Nijmegen, 13 oktober 1998 Promotores : Gribnau, F.W.J., Hekster, Y.A. 163 p.

Published
1998

46. Drug transport and drug-nutrient interactions in the human placenta

Author

Aa, E.M. van der, Gribnau, F.W.J., Noordhoek, J., and Radboud University Nijmegen

Subjects
Drug transport in human placenta, GeneralLiterature_REFERENCE(e.g.,dictionaries,encyclopedias,glossaries), Transport van farmaca in de humane placenta
Abstract

Contains fulltext : mmubn000001_210333693.pdf (Publisher’s version ) (Open Access) Promotores : F. Gribnau, J. Noordhoek, F. Russel en J. Copius Peereboom-Stegeman 152 p.

Published
1995

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