NIS Considerations
CHCUK NewsletterMarch 2011
In this Month's Issue
Czech Republic: Experience in NIS Data Collection
Austria: Updated NIS Guidance

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Greetings!

This month, It's my pleasure to present you with a guest article authored by Dr Vit Kandrnal and his team from Masaryk University Brno on their experience in non-interventional data collection in the Czech Republic.

Best wishes,
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Stuart McCully
CHCUK
 
Tel: +44 (0) 1997 42 33 11
Mobile: +44 (0) 7909 111 510
email: stuart.mccully@chcuk.co.uk
Czech Republic: Experience in NIS Data Collection
Institute of Biostatistics and Analyses, Masaryk University Brno: Our Experience in Non-interventional Data Collection in the Czech Republic
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Kandrnal V., Brabec P., Klimes D., Schwarz D., Majek O., Blaha M., Hrebicek J., Dusek L.


A history of non interventional data collection in the Czech Republic has been, to some extent, associated with epidemiological studies, clinical registries and non-interventional clinical trials carried out in different fields of cancer care. Standardized sets of data about diagnostic procedures, diagnoses, treatment and its outcome have been systematically collected in Czech National Cancer Registry (CNCR) since 1977. The registration of malignant cancers is stipulated by the Czech law and is obligatory for all healthcare institutions. Data analyses from this registry have become a benchmark for analysis of non-interventional studies. Institute of Biostatistics and Analyses, Masaryk University, Brno (IBA MU, www.iba.muni.cz ) has created an on-line application (http://www.svod.cz ), which makes the CNCR analyses widely accessible. The aim of IBA MU is to update these analyses on an annual basis.

 

In addition to CNCR, IBA MU has become responsible for central data management of three specific information systems and registries of all three national cancer screening programmes (breast cancer, colorectal cancer and cervical cancer). Data from these information systems have helped the Czech professional medical societies to assess the screening programmes and to optimize their performance and quality control (www.mamo.cz, www.cervix.cz, www.kolorektum.cz).

 

There is no doubt that CNCR and cancer screening programme registries have become a valuable and widely used source of information. These tools have been recently diversified into several diagnostically specific projects, e.g. www.uroweb.cz. Furthermore, the main and most important pool of information on standard clinical practice in oncology have been clinical registries and databases of the Czech Society for Oncology (CSO) the results of which have been regularly published on the official CSO web page (http://www.linkos.cz/english/index.php).

 

This family of more than 20 active registries, or more generally, research databases,(e.g. Alert - acute leukaemia registry, Avastin - registry of patients with advanced colorectal carcinoma treated with bevacizumab, Camelia - registry of patients with chronic myeloid leukaemia, Register - registry of patients with gastrointestinal stromal tumours, Interb - registry of HER2 positive breast cancer patients, Ikarus - registry of patients with metastatic solid tumours, RMG - registry of monoclonal gammopaties etc.) enables collection of relevant data regarding diagnostic and therapeutic procedures. They are typically designed to monitor a specific treatment or a well defined group of patients. Together with CNCR and cancer screening programmes registries they constitute comprehensive information - registration system which enables to assess not only the treatment outcomes, but also population-based indicators of quality and regional health care availability.

 

During the last 10 years, also other medical societies have recognised the importance of local as well as national registries and non-interventional data collection systems and initiated development of more than 50 projects in order to evaluate the situation in respective medical fields. Considerable number of these non-interventional data collection projects and data analyses has been carried out with direct or indirect support of IBA MU (http://www.iba.muni.cz).

 

The second most prominent group of clinicians which should be mentioned in terms of data collection in the Czech Republic is the Czech Society of Cardiology. This society supports projects such as Ahead - registry of patients with acute heart failure, Kardio ICD - national registry of patients with implantable cardioverter-defibrillator, Katab - national registry of patients that underwent catheter ablation and other (http://www.registry.cz).

 

Medical societies with numerous members are not the only professional groups that participate in clinical data collection projects. An excellent example of projects focused on a relatively small groups of patients are Amadeus, registry of patients with the wet form of age related macular degeneration (wet AMD) (http://amadeus.registry.cz/index-en.php ), supported by the Czech Society of Ophthalmology, and/or the DMD/BMD project - registry of patients diagnosed with Duchenne/Becker Muscular Dystrophy (http://dystrofie.registry.cz/), which has been run by IBA MU in conjunction with a registered charitable organization "Parent Project".

 

Despite the fact that private contract research organizations (http://www.acro-cz.cz/en/clenove.html ) have made a notable contribution to organizing and running non-interventional studies in the Czech Republic over the past several years, this field remains the domain of academically driven projects with support of Czech medical and scientific societies, research institutes and universities.

 

All the academically driven research databases are also opened to a multidisciplinary research focused on optimization of data management processes and information mining. As an example we can mention projects "TaToo" - Tagging tool based on a semantic discovery framework (http://www.tatoo-fp7.eu/tatooweb ) and I-COP - Information Centre for Oncology Care, a data mining tool which can use various sources of clinical and administrative information, carry out comprehensive data analysis and provide results in structured and if required schematic form.

   

Quick guide for running academic, non-interventional clinical trial in the Czech Republic:

  1. Find out whether or not there is a similar project running in the Czech Republic (medical and scientific societies, IBA MU).
  2. Assess the legal requirements for running non-interventional clinical trials in the Czech Republic (the latest version of CHCUK book "NIS in Europe" is up to date).
  3. Obtain a support of a professional/scientific society that will recommend the approach taking into consideration specifics of each society.

 

 

Contact:

Dr. Vit Kandrnal, MD.,

Manager of clinical projects

Institute of Biostatistics and Analyses

Masaryk University, Brno

Czech Republic


 

Austria: Updated Guidance on Conduct of NIS
Updated Scientific Guidance for the Conduct of Non-Interventional Studies in Austria Available 
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The Scientific Guidance for the Conduct of Non-interventional Studies (NIS) in Austria originally published in August 2010 were updated on the 28 January 2011 (see link below).

 

 

Non-interventional Studies (NIS)

 

To align with the European terminology, the term "Anwendungsbeobachtung" was replaced by the term "Non-interventional Study" through the Amendment BGBl. I Nr. 63/2009 to the Austrian Medicinal Product Act (AMG). The requirement to plan and conduct these studies according to the scientific state-of-the-art was additionally introduced, with a view to the foreseen reporting obligation.

 

The power to issue a reporting obligation and to establish a public registry for Non-interventional Studies was introduced to the Austrian Medicinal Product Act in § 48 para 3 through Amendment BGBl. I Nr. 153/2005.

  

 

The power of authority of the Secretary of Health to issue reporting rules for Clinical Trials and Non-interventional Studies with respect to drug safety is outlined in § 48. It is further elaborated in paragraph 3 empowering the Secretary of Health, with a view to drug safety and international scientific standards, to issue ordinance on the reporting obligations for Non-interventional Trials, including a registry for these studies with partial accessible by the public.

 

These reporting rules were issued in the National Regulation for the Reporting Obligations for Non-interventional Studies on June 17th 2010, (Verordnung des Bundesministers für Gesundheit über die Meldepflicht von Nicht-interventionellen Studien), BGBL. II Nr. 180/2010. Any Non-interventional study initiated after September 1st 2010 has to be registered with the BASG.

 

Reporting obligation

 

Non-interventional studies fall under the reporting obligation, if the inclusion of the first patient occured on or after September 1st 2010. The regulation is not applicable to Non-interventional studies where the first patient was included prior to this date.

 

Notice: The registration portal for Non-interventional Studies and the public registry are accessible via the  AGES PharmMed-e-Service-Portal.

 

For further information refer to:   

 

 

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