- Email: [email protected]
Clinical Research Networks as A Support to Independent Clinical Trials
Parallel Session Abstracts 2. Puntis JW. Gastro-oesophageal reflux in young babies: who should be treated? Arch Dis Child 2015; 0: 1-5. doi:10.1136/archdischild2014-306232.
Initiative on Medication Reviews and Dialogues M.B. Christensen; K.M. Harboe; J.P.K. Kampmann; A. Kobberø; G. Jürgens; J. Sonne; L. Reuther; and H.R. Christensen Copenhagen University Hospital Bispebjerg and Frederiksberg, Copenhagen, Denmark We have successfully implemented a multifaceted initiative to enhance rational pharmacotherapy, pharmacological focus, and clinical pharmacological decision making across health care systems in our region. The initiative promotes clinical pharmacology as a clinical discipline and consists of 4 key elements: 1. Primary practice and hospitals in the region are offered systematic reviews of a patient’s list of medicines forwarded by e-mail, fax, or phone. Medication reviews are aimed at optimising the combined list of medicines focusing on efficacy, interactions, adverse effects, collective drug burden, and cost-effectiveness of the medication. The medication review is performed by junior doctors and approved by a specialist in clinical pharmacology and returned to the inquirer within 2 days. 2. Acute medical ward medication review. Clinical pharmacists employed at the acute medicine department of the local hospital are supported with 1) patient-specific acute clinical pharmacological input when necessary and 2) evaluation and education based on appraisal and grading of the clinical pharmacist’s suggestions in relation to the individual patient charts. Clinical scientific projects concerning medication reviews as an alliance between clinical pharmacists and clinical pharmacologist are in development. 3. Psychiatric medication dialogues. Medication reviews of complex psychiatric patient’s medication. The cases, chosen beforehand and submitted by psychiatrists, are reviewed by a clinical pharmacologist. Problematic areas of the medication are subsequently discussed bilaterally at conference meeting held at the psychiatric department. 4. Primary practice medication dialogues. Medication reviews of primary practice patient’s medication. The cases, chosen beforehand and submitted by general practitioners, are reviewed by a pharmacist followed by a specialist in clinical pharmacology. Suggestions for change and optimisation are subsequently presented to the general practitioner at a dialogue based meeting held in the general practitioners private practice.
Clinical Research Networks as A Support to Independent Clinical Trials J. Demotes-Mainard ECRIN, Paris, France Independent multinational trials are key instruments to optimise healthcare strategies and to promote evidence-based medical practice in Europe and globally. However conducting multinational trials raises major obstacles for academic institutions, both on the trial management side and on the clinical investigation side. Due to the fragmentation of health and legislative systems, infrastructure, tools, procedures, and funding, a majority of non-commercial sponsors and clinical trial units (CTUs) lack the capacity to initiate and manage trials in foreign countries. ECRIN (European Clinical Research Infrastructure Network, www.ecrin.org) was designed to overcome these barriers, as a distributed, non-profit infrastructure supporting multinational clinical trials in Europe. By connecting and coordinating national CTU networks, ECRIN
August 2015
supports the management of multinational trials. ECRIN is open to the whole clinical research community, covering any disease area. Support to the management of multinational trials is provided after scientific evaluation of the full protocol. Most ECRIN-supported trials are funded by the FP7 and H2020; however, other funding mechanisms are being explored. Typical ECRIN users are multinational investigator consortia conducting independent trials. In our experience, structuring investigation capacity through the development of pan-European investigation networks has a tremendous impact on the development and the conduct of the project. For this reason, ECRIN also promotes the structuring of pan-European, disease-oriented investigation networks that become strategic partners, providing the scientific content and investigation capacity, whereas ECRIN supports the trial management. This is for instance achieved in the current FP7 ECRIN-IA project for the rare disease, medical device, and nutrition investigator communities, and similar partnerships are being developed with other disease areas.
Impact of biosimilar medicinal products in the EU pharmaceutical market A. Grozdanova; K. Ancevska Netkovska; Z. Sterjev; Z. Naumovska; A. Kapedanovska Nestorovska; and L.j Suturkova Faculty of Pharmacy, University Ss. Cyril and Methodius, Skopje, Macedonia Biosimilar medicinal products marketed for almost a decade are still relatively small segment of the EU pharmaceutical market, but with strong annual growth. The presence of biosimilars has enhanced competition and offered a less costly alternative to existing biologicals. There is a strong interest by healthcare stakeholders in measuring the biosimilar utilization and impact on the market entry. Regulatory issues, manufacturing, safety, pricing, and physician and patient acceptance have a part in developing the biosimilar market much different from the generic market. The lack of automatic substitution and interchangeability made the entry of biosimilars even more difficult. The purpose of this research was to evaluate the information related to impact of biosimilars and their potential to penetrate the EU market. The assessment of the biosimilar market uptake is done using data from several sources, measuring volume consumption and pricing information in EU countries where they are marketed. Different types of biosimilars have different market penetration potential, with very limited data for biosimilar monoclonal antibodies and biosimilar insulins. Noticeable differences in the use of biosimilars across EU countries are reflection of national treatment practices and guidelines, which are influenced by funding decisions and payer actions. The theoretical prediction that biosimilar competition will lead to major price erosion in practice has not been so significant. Despite those difficulties, it is expected that the biosimilar market will develop, mainly driven by potential profits with patent expiration in the next years. Even though the most important conditions for market uptake of biosimilars are driven by commercial factors, still, real clinical evidence, clear regulatory framework, and postmarketing data on the use of biosimilars will influence their market access.
Personalised Pharmacotherapy In Routine Clinical Pharmacological Practice M. Grundmann Department of Clinical Pharmacology, Faculty of Medicine, University of Ostrava, Czech Republic
e163
Initiative on Medication Reviews and Dialogues M.B. Christensen; K.M. Harboe; J.P.K. Kampmann; A. Kobberø; G. Jürgens; J. Sonne; L. Reuther; and H.R. Christensen Copenhagen University Hospital Bispebjerg and Frederiksberg, Copenhagen, Denmark We have successfully implemented a multifaceted initiative to enhance rational pharmacotherapy, pharmacological focus, and clinical pharmacological decision making across health care systems in our region. The initiative promotes clinical pharmacology as a clinical discipline and consists of 4 key elements: 1. Primary practice and hospitals in the region are offered systematic reviews of a patient’s list of medicines forwarded by e-mail, fax, or phone. Medication reviews are aimed at optimising the combined list of medicines focusing on efficacy, interactions, adverse effects, collective drug burden, and cost-effectiveness of the medication. The medication review is performed by junior doctors and approved by a specialist in clinical pharmacology and returned to the inquirer within 2 days. 2. Acute medical ward medication review. Clinical pharmacists employed at the acute medicine department of the local hospital are supported with 1) patient-specific acute clinical pharmacological input when necessary and 2) evaluation and education based on appraisal and grading of the clinical pharmacist’s suggestions in relation to the individual patient charts. Clinical scientific projects concerning medication reviews as an alliance between clinical pharmacists and clinical pharmacologist are in development. 3. Psychiatric medication dialogues. Medication reviews of complex psychiatric patient’s medication. The cases, chosen beforehand and submitted by psychiatrists, are reviewed by a clinical pharmacologist. Problematic areas of the medication are subsequently discussed bilaterally at conference meeting held at the psychiatric department. 4. Primary practice medication dialogues. Medication reviews of primary practice patient’s medication. The cases, chosen beforehand and submitted by general practitioners, are reviewed by a pharmacist followed by a specialist in clinical pharmacology. Suggestions for change and optimisation are subsequently presented to the general practitioner at a dialogue based meeting held in the general practitioners private practice.
Clinical Research Networks as A Support to Independent Clinical Trials J. Demotes-Mainard ECRIN, Paris, France Independent multinational trials are key instruments to optimise healthcare strategies and to promote evidence-based medical practice in Europe and globally. However conducting multinational trials raises major obstacles for academic institutions, both on the trial management side and on the clinical investigation side. Due to the fragmentation of health and legislative systems, infrastructure, tools, procedures, and funding, a majority of non-commercial sponsors and clinical trial units (CTUs) lack the capacity to initiate and manage trials in foreign countries. ECRIN (European Clinical Research Infrastructure Network, www.ecrin.org) was designed to overcome these barriers, as a distributed, non-profit infrastructure supporting multinational clinical trials in Europe. By connecting and coordinating national CTU networks, ECRIN
August 2015
supports the management of multinational trials. ECRIN is open to the whole clinical research community, covering any disease area. Support to the management of multinational trials is provided after scientific evaluation of the full protocol. Most ECRIN-supported trials are funded by the FP7 and H2020; however, other funding mechanisms are being explored. Typical ECRIN users are multinational investigator consortia conducting independent trials. In our experience, structuring investigation capacity through the development of pan-European investigation networks has a tremendous impact on the development and the conduct of the project. For this reason, ECRIN also promotes the structuring of pan-European, disease-oriented investigation networks that become strategic partners, providing the scientific content and investigation capacity, whereas ECRIN supports the trial management. This is for instance achieved in the current FP7 ECRIN-IA project for the rare disease, medical device, and nutrition investigator communities, and similar partnerships are being developed with other disease areas.
Impact of biosimilar medicinal products in the EU pharmaceutical market A. Grozdanova; K. Ancevska Netkovska; Z. Sterjev; Z. Naumovska; A. Kapedanovska Nestorovska; and L.j Suturkova Faculty of Pharmacy, University Ss. Cyril and Methodius, Skopje, Macedonia Biosimilar medicinal products marketed for almost a decade are still relatively small segment of the EU pharmaceutical market, but with strong annual growth. The presence of biosimilars has enhanced competition and offered a less costly alternative to existing biologicals. There is a strong interest by healthcare stakeholders in measuring the biosimilar utilization and impact on the market entry. Regulatory issues, manufacturing, safety, pricing, and physician and patient acceptance have a part in developing the biosimilar market much different from the generic market. The lack of automatic substitution and interchangeability made the entry of biosimilars even more difficult. The purpose of this research was to evaluate the information related to impact of biosimilars and their potential to penetrate the EU market. The assessment of the biosimilar market uptake is done using data from several sources, measuring volume consumption and pricing information in EU countries where they are marketed. Different types of biosimilars have different market penetration potential, with very limited data for biosimilar monoclonal antibodies and biosimilar insulins. Noticeable differences in the use of biosimilars across EU countries are reflection of national treatment practices and guidelines, which are influenced by funding decisions and payer actions. The theoretical prediction that biosimilar competition will lead to major price erosion in practice has not been so significant. Despite those difficulties, it is expected that the biosimilar market will develop, mainly driven by potential profits with patent expiration in the next years. Even though the most important conditions for market uptake of biosimilars are driven by commercial factors, still, real clinical evidence, clear regulatory framework, and postmarketing data on the use of biosimilars will influence their market access.
Personalised Pharmacotherapy In Routine Clinical Pharmacological Practice M. Grundmann Department of Clinical Pharmacology, Faculty of Medicine, University of Ostrava, Czech Republic
e163