RESUMO
In the European Union (EU), 27 May 2014 was a significant date for clinical trials. Since that day, the EU Clinical Trials Regulation 536/2014 (EU-CTR) officially came into force. The new EU-CTR replaces EU Directive 2001/20/EC and fundamentally reforms the way clinical trials are applied for and conducted in Europe. For clinical trial sponsors, the responsible regulatory authorities, ethics committees, and all EU member states, the new EU-CTR brings profound changes. However, it has taken a long time for the new regulation to be applied, as the establishment of the new Clinical Trials Information System (CTIS) of the European Medicines Agency (EMA) has taken some time. Contrary to expectations, the establishment of this system could not be completed in 2016, but only with a notification from the EMA on 31 July 2021.Overall, Germany is well prepared for the new regulation. The German Medicinal Products Act (AMG) was adjusted at an early stage. Authorities and ethics committees have tested the cooperation in a pilot phase from 2015 to 2021 and have shown that the cooperation in Germany works well in the evaluation of applications.However, initial experience from the application process shows that there are some fundamental problems with CTIS and that there is also a need for further adaptation at the national level in Germany. This includes, for example, the integration of the Federal Office for Radiation Protection (BfS) approval or the harmonization of ethics committee requirements. It is important that Germany addresses these points at the national level to remain competitive.
Assuntos
Ensaios Clínicos como Assunto , Indústria Farmacêutica , Comissão de Ética , União Europeia , AlemanhaRESUMO
The objective of clinical trials is to transfer findings gained from basic research to patients and to result in innovative treatment approaches. Along with basic research, results from clinical trials thus represent a core area of medical advances. As a location for clinical trials, Germany is currently well-positioned and internationally competitive. This is evident in its position as No. 2 in Europe and No. 3 worldwide - behind the US and UK - in clinical trials of pharmaceuticals [1]. Maintaining and further improving this favorable positioning as a location for clinical trials is in the mutual interest of all parties involved in the field of clinical research, patients, trial sites and sponsors of clinical trials. For patients, clinical trials offer opportunities to gain early access to innovative therapy options. In addition to the scientific interest from medical faculties, clinical research is thereby an important aspect for university clinics in Germany as they fulfill their medical care mandate. Their involvement in clinical trials gives physicians the ability to gather experience with new treatment approaches at an early stage and to pass this know-how on to their patients. A location's clinical research is thus an important competitive factor in terms of international comparison as well. Industry likewise benefits from the favorable research infrastructure in Germany, which provides rapid patient recruitment and outstanding quality of results obtained and can thus contribute to the early approval of new drugs. From the perspective of the authors, it is therefore essential that Germany continues to remain competitive as a location for conducting clinical trials, precisely because the number of clinical trials is decreasing overall. Companies themselves are in international competition internally and externally, which often creates a certain pressure on trial preparation and thus on the start of a clinical trial. To ensure that a clinical trial can begin early, it is essential that contracts related to the trial are concluded quickly and simply, including remuneration for participants and full, transparent and comprehensible coverage of content for the business relationship. The swift agreement of key contractual and budgetary aspects is therefore in the interest of everyone involved. Against this backdrop, the German Association of Medical Faculties (MFT), the German Association of Academic Medical Centers (VUD), the Coordination Center for Clinical Studies (KKS-Netzwerk) and the German Association of Research-Based Pharmaceutical Companies (vfa) have held joint discussions regarding an important aspect of the contract negotiations - the cost consideration of clinical trials. As a result of these talks, these organizations have developed and published joint "Recommendations for the preparation of a total services calculation for remuneration related to the conduct of a clinical trial in a trial center" [2], [3]. The parties concerned share the conviction that, against the backdrops described, it would be helpful if the potential contract partners had access to recommendations that offer examples of constantly recurring cost positions in order to more precisely determine remuneration related to the conduct of a clinical trial. This article explains how the "Recommendations for the preparation of a total services calculation for remuneration related to the conduct of a clinical trial in a trial center" [2], [3] were developed and provides an overview of their content.
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Ensaios Clínicos como Assunto/organização & administração , Contratos , Ensaios Clínicos como Assunto/economia , Contratos/economia , Contratos/normas , Indústria Farmacêutica/economia , Indústria Farmacêutica/organização & administração , Alemanha , Humanos , RemuneraçãoRESUMO
In recent years, the number and scope of outsourced activities in the pharmaceutical industry have increased heavily. In addition, also the type of outsourcing has changed significantly in that time. This raises the question of whether and how sponsors retain the capability to select and to control the contract research organizations (CROs) involved and what expertise still has to be present in the development department as well as other relevant departments to ensure adequate oversight, also in line with the expectations of regulators and health authorities. In order to answer these questions, a survey was conducted among the German vfa member companies. The survey describes the latest developments and experiences in outsourcing by 18 German vfa member companies. It concentrates on measures how to implement Quality Assurance (QA) when performing outsourced clinical studies. This study shows that the majority of companies apply a full-outsourcing, preferred-provider model of clinical trial services, with the clinical research department playing the major role in this process. A large amount of guiding documents, processes and tools are used to ensure an adequate oversight of the services performed by the CRO(s). Finally the guiding principles for all oversight processes should be transparent communication, a clearly established expectation for quality, a precise definition of accountability and responsibility while avoiding silo mentality, and a comprehensive documentation of the oversight's evidence. For globally acting and outsourcing sponsors, oversight processes need to be aligned with regards to local and global perspectives. This survey shows that the current implementation of oversight processes in the participating companies covers all relevant areas to ensure highest quality and integrity of the data produced by the outsourced clinical trial.
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Pesquisa Biomédica/métodos , Contratos/estatística & dados numéricos , Indústria Farmacêutica/estatística & dados numéricos , Pesquisa Biomédica/organização & administração , Pesquisa Biomédica/estatística & dados numéricos , Indústria Farmacêutica/organização & administração , Alemanha , Humanos , Serviços Terceirizados/estatística & dados numéricos , Controle de Qualidade , Inquéritos e QuestionáriosRESUMO
Although the use of psychotropic medications in child and adolescent psychiatry in Germany is on the increase, most compounds are in fact prescribed "off-label" because of a lack of regulatory approval in these age groups. In 2007, the European Parliament introduced Regulation 1901/2006 concerning medicinal products in pediatric populations, with a subsequent amendment in the form of Regulation 1902/2006. The main aim of this legislation was to encourage research and clinical trials in children and adolescents, and thus promote the availability of medications with marketing authorization for these age groups. Furthermore, initiatives such as the European 7th Framework Program of the European Union now offer substantial funding for pediatric pharmacological research. At a recent Congress of the German Society for Child and Adolescent Psychiatry and Psychotherapy (DGKJP), experts from the field and the pharmaceutical industry held a symposium with lay representatives in order to discuss attitudes toward, and experience with, pediatric psychopharmacology research in Germany since 2007. Several areas of concern were identified. The present paper derives from that symposium and provides an overview of these opinions, which remain crucial to the field. A wider discussion of how to facilitate psychopharmacological research in Germany in order to optimize the treatment and welfare of children and adolescents with psychiatric disorders is now warranted.
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Ensaios Clínicos como Assunto/legislação & jurisprudência , Aprovação de Drogas/legislação & jurisprudência , União Europeia , Transtornos Mentais/tratamento farmacológico , Psicotrópicos/efeitos adversos , Psicotrópicos/uso terapêutico , Adolescente , Psiquiatria do Adolescente/legislação & jurisprudência , Criança , Psiquiatria Infantil/legislação & jurisprudência , Comportamento Cooperativo , Indústria Farmacêutica/legislação & jurisprudência , Alemanha , Humanos , Comunicação Interdisciplinar , Uso Off-Label/legislação & jurisprudênciaRESUMO
UNLABELLED: The German AMNOG healthcare reform includes a mandatory early-benefit-assessment (EBA) at launch. As per German social code, EBA is based on registration trials and includes evaluation of the patient-relevant effect of the new medicines compared to an appropriate comparator as defined by the Federal Joint Committee (G-BA). Current EBA decisions released have unveiled issues regarding the acceptance of some patient-relevant endpoints as G-BA and IQWiG are grading the endpoints, focusing on overall survival as the preferred endpoint in oncology.A taskforce of experienced German outcomes research, medical, health-technology assessment and biostatistics researchers in industry was appointed. After agreement on core assumptions, a draft position was prepared. Input on iterative versions was solicited from a panel of reviewers from industry and external stakeholders.Distinctive features of registration trials in oncology need to be considered when these studies form basis for EBA, especially in cancer-indications with long post-progression survival; and with several consecutive therapeutic options available post-progression. Ethical committees, caregivers and patients often demand cross-over-designs diluting the treatment-effect on overall survival. Regulatory authorities require evaluation of morbidity-related study endpoints including survival of patients without their disease getting worse (i.e., progression-free survival). Also, progression requires treatment-changes, another strong indicator for its relevance to patients.Based on specific guidelines and clinical trial programs that were developed to be consistent with regulatory guidance, endpoints in oncology are thoroughly evaluated in terms of their patient-relevance. This extensive knowledge and experience should be fully acknowledged during EBA when assessing the patient-relevant benefit of innovative medicines in oncology. JEL CODES: D61; H51; I18.
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In 2007 the Association of Research-Based Pharmaceutical Companies (vfa) published recommendations to improve the quality and transparency of non-interventional studies. These recommendations include quality assurance measures, in particular with respect to transparency as well as for the verification of the data collected in these studies. This publication presents the results of a survey on fees in non-interventional studies which was conducted within the member companies of the vfa in June 2011. These results demonstrate a consistent adherence to the statutory requirements and the implementation of the recommendations concerning the remuneration of the study centers. Depending on the indication, the number of routine doctor/patient contacts is different and associated with that number the documentation efforts vary. Accordingly, the fee varies based on the fee schedule for physicians (German: Gebührenordnung für Ärzte) by taking into account the actual efforts at the study center.
Assuntos
Indústria Farmacêutica/economia , Custos de Cuidados de Saúde/legislação & jurisprudência , Vigilância de Produtos Comercializados/economia , Remuneração , Indústria Farmacêutica/legislação & jurisprudência , Prescrições de Medicamentos , Alemanha , Humanos , Padrões de Prática Médica , Inquéritos e QuestionáriosRESUMO
After the regulatory approval has been obtained, epidemiological studies are acknowledged scientific medical research methods for a new drug which provide additional knowledge about routine application of the drug in clinical daily routine. These studies are performed according to the recommendations of both international and national expert associations, the recommendations of the higher federal authorities in Germany and according to the recommendations of the associations of the pharmaceutical industry. Two surveys among the member companies of the Association of Research-based Pharmaceutical Companies investigated the status of the implementation of the recommendations in the years 2008 and 2010 and compared the results with each other. It could be shown that these recommendations were implemented successfully and were fully adhered to during the conduct of non-interventional studies in Germany. The recommendations define a quality standard which justifies a high level of confidence in the validity of the data collected and the results from these investigations.