Availability of pharmaceutical drugs

Borst-Eilers, E

doi:10.1016/s0140-6736(00)91992-5

Cited by 8 publications

(6 citation statements)

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“…Finally, adapted questions were translated into English and presented to the developer of the PPIC survey to ask for feedback and approval (the survey is available from the authors on request). This study was exempt from review by the Medical Research and Ethics Committee since it was not liable according to the Dutch Medical Research (Human Subjects) Act [24]. …”

Section: Theory and Methodsmentioning

confidence: 99%

Translating the Patient Perception of Integrated Care Survey to Measure Integrated Care in the Netherlands: Combining Equivalence and Contextualization Approaches for Optimal Results

Tietschert

Angeli

Raak

et al. 2016

International Journal of Integrated Care

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Introduction:An increase in initiatives to improve integration of care provides the need for instruments that assess the degree of integrated care as perceived by patients across cultural contexts. This article aims to explain the relevance of equivalence and contextualization approaches in translating and adapting the Patient Perception of Integrated Care Survey developed in the US for use in the Netherlands.Theory and methods:The World Health Organization guidelines guided the translation and adaptation, including a forward-backward translation and patient-feedback through informal contacts (N4) and cognitive interviews (N14).Results:The forward-backward translation produced a Dutch version of the Patient Perception of Integrated Care Survey with minor adaptations. Patients evaluated the survey as very relevant. Alterations resulted from structural and cultural differences and specificities of patients with chronic conditions.Conclusions and discussion:A context-sensitive translation process is key to developing instruments for cross-cultural health research. Our results show that equivalence- and contextualization methods provide equally relevant, yet substantially different contributions to the translation outcome and should both be incorporated when translating instruments for different cultural contexts. The results support the applicability of the Patient Perception of Integrated Care Survey in the Netherlands and are promising for its adoption in other cultural contexts.

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Section: Theory and Methodsmentioning

confidence: 99%

Translating the Patient Perception of Integrated Care Survey to Measure Integrated Care in the Netherlands: Combining Equivalence and Contextualization Approaches for Optimal Results

Tietschert

Angeli

Raak

et al. 2016

International Journal of Integrated Care

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“…The ICH process might serve as a role model for a similar collaborative effort between third-party payers, manufacturers, and academic researchers in outcomes research. A similar concept has already been called for, even by healthcare decision makers themselves [30]. However, it is important to distinguish between scientific assessment, which can be readily harmonized, and appraisal, which cannot, due to different healthcare systems, political environments, and willingness to pay.…”

Section: Case Study 1: the Ich Processmentioning

confidence: 99%

Outcomes research collaborations between third-party payers, academia, and pharmaceutical manufacturers

2006

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Research collaborations between academic researchers, regulatory agencies, and pharmaceutical manufacturers have made the drug development process more efficient and have frequently supported the successful documentation of quality, safety, and efficacy of pharmaceuticals (the so-called three hurdles). Over recent years issues of drug cost, access, and utilization have moved to center stage, giving rise to a "fourth hurdle approval" process by third-party payers. This requires new forms of collaborative research among new players. This contribution highlights the need for a "triangular" relationship in the field of outcomes research between scientists in academia, third-party payer institutions, and pharmaceutical manufacturers. We discuss, and illustrate by case studies, how successful models of collaboration from the drug development process might be relevant to research activities related to the fourth hurdle. Case studies which may provide useful models for collaborative outcomes research include the "International Conference on Harmonization" process, the voluntary consultation procedures established by drug regulatory agencies, and the Quebec experience in database sharing.

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“…Regarding the question of the right time for the licensing of a new drug [1][2][3]5], the question facing the health authorities at present is much more how extensive the data on a new substance must be in order for them to be used as the basis for a solid, reliable assessment of drug safety. This question is, however, not primarily dependent on surrogate end points, but on the degree of probability that is required, with which statements concerning the safety of a drug can be made before it is approved [49].…”

Section: Present Attitude Of the Regulatory Authoritiesmentioning

confidence: 99%

“…Are the requirements placed on promising substances before they can be considered ready for licensing too stringent? These are questions which are not only raised by the pharmaceutical industry, but which have also recently been discussed within the medical profession [1] and have been raised very concretely by patients' organizations [2]: these organizations ask that the patients' views should be considered in regard to the assessment of the relevance of clinical data and end points [3]. The interests lying behind these questions are often divergent.…”

Section: Introductionmentioning

confidence: 99%

The Impact of Biomarkers and Surrogate End Points on Regulatory Approval of New Drugs

Kleist¹

2002

Heart Drug

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Biomarkers are becoming increasingly important in the process of development of new drugs. However, as they are often not able to reflect the actual clinical value and safety of a drug, their role in the framework of the licensing of drugs is limited. For the health authorities, proof of a positive benefit/risk ratio based on hard clinical end points is generally the decisive factor. Only in very few indications do validated surrogate end points exist that show a high predictive value for a relevant clinical end point – the granting of marketing authorization on the basis of a surrogate end point alone is therefore the exception. In principle, this is also true for drugs for the treatment of serious, life-threatening diseases, as the present accelerated approval procedures for the granting of a license on the basis of provisional data and without direct proof of a clinical benefit are used by the authorities only in isolated cases. Only if new biomarkers can be validated as surrogate end points for hard clinical end points can their value for the licensing of new drugs increase in the future.

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Availability of pharmaceutical drugs

Cited by 8 publications

References 0 publications

Translating the Patient Perception of Integrated Care Survey to Measure Integrated Care in the Netherlands: Combining Equivalence and Contextualization Approaches for Optimal Results

Translating the Patient Perception of Integrated Care Survey to Measure Integrated Care in the Netherlands: Combining Equivalence and Contextualization Approaches for Optimal Results

Outcomes research collaborations between third-party payers, academia, and pharmaceutical manufacturers

The Impact of Biomarkers and Surrogate End Points on Regulatory Approval of New Drugs

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