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Quality assurance in non-interventional studies
Nowadays, drug research and surveillance after authorisation becomes more and more important for several reasons. Non-interventional studies (NIS) investigate various aspects of drug use including efficacy and safety under real life conditions. Such kind of health services research should be on a hi...
Autores principales: | , , , , |
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Formato: | Texto |
Lenguaje: | English |
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German Medical Science GMS Publishing House
2009
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2778825/ https://www.ncbi.nlm.nih.gov/pubmed/19949447 http://dx.doi.org/10.3205/000088 |
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author | Theobald, Karlheinz Capan, Müge Herbold, Marlis Schinzel, Stefan Hundt, Ferdinand |
author_facet | Theobald, Karlheinz Capan, Müge Herbold, Marlis Schinzel, Stefan Hundt, Ferdinand |
author_sort | Theobald, Karlheinz |
collection | PubMed |
description | Nowadays, drug research and surveillance after authorisation becomes more and more important for several reasons. Non-interventional studies (NIS) investigate various aspects of drug use including efficacy and safety under real life conditions. Such kind of health services research should be on a high scientific, methodological and organisational level. Therefore accompanying measures to improve or to keep the quality are highly recommended. The aim of quality management is: first to avoid bias of results by using an appropriate study design and an adequate data analysis, second to assure authenticity, completeness and validity of the data and third to identify and resolve deficiencies at an early stage. Basic principles are laid down in corresponding guidelines and recommendations of authorities, institutes and societies. Various guidelines for good epidemiological practice (GEP) were published by the U.S. Food and Drug Administration (FDA) and international and regional societies for epidemiology. In addition in Germany the Federal Institute for Drugs and Medical Devices (BfArM) together with the Paul Ehrlich Institute (PEI) and the German Association of Research-Based Pharmaceutical Companies (VFA) have published respectively recommendations dealing with quality aspects of non-interventional observational studies. Key points are the advanced publishing of information about the project, developing of a study plan/protocol containing the scientific objectives, a sample size justification and a description of the planned analyses and the publishing of a summary of the results timely after completion of the study. The quality of the data can be improved by using standardized case report forms (CRF) and the CRF should be reviewed and tested before start of study by some participants. A source data verification (SDV) should be performed in randomly selected centres – in between 2% and 5% of the centres depending on the number of participating centres. Before start of statistical analysis a statistical analysis plan (SAP) should be created. The use of standardized tables and figures is highly recommended. The basis of the report writing should be the STROBE-statement “Strengthening the Reporting of Observational studies in Epidemiology Initiative” containing a checklist of 22 points to be covered in the report. The development of own standard operating procedures (SOP) describing the processes during planning, conduct and evaluation of a non-interventional study as well as the quality management and the regular training of all involved people is also highly recommended. All accompanying measures to improve or to keep the quality of the NIS should not violate the concept of non-intervention. |
format | Text |
id | pubmed-2778825 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2009 |
publisher | German Medical Science GMS Publishing House |
record_format | MEDLINE/PubMed |
spelling | pubmed-27788252009-11-30 Quality assurance in non-interventional studies Theobald, Karlheinz Capan, Müge Herbold, Marlis Schinzel, Stefan Hundt, Ferdinand Ger Med Sci Article Nowadays, drug research and surveillance after authorisation becomes more and more important for several reasons. Non-interventional studies (NIS) investigate various aspects of drug use including efficacy and safety under real life conditions. Such kind of health services research should be on a high scientific, methodological and organisational level. Therefore accompanying measures to improve or to keep the quality are highly recommended. The aim of quality management is: first to avoid bias of results by using an appropriate study design and an adequate data analysis, second to assure authenticity, completeness and validity of the data and third to identify and resolve deficiencies at an early stage. Basic principles are laid down in corresponding guidelines and recommendations of authorities, institutes and societies. Various guidelines for good epidemiological practice (GEP) were published by the U.S. Food and Drug Administration (FDA) and international and regional societies for epidemiology. In addition in Germany the Federal Institute for Drugs and Medical Devices (BfArM) together with the Paul Ehrlich Institute (PEI) and the German Association of Research-Based Pharmaceutical Companies (VFA) have published respectively recommendations dealing with quality aspects of non-interventional observational studies. Key points are the advanced publishing of information about the project, developing of a study plan/protocol containing the scientific objectives, a sample size justification and a description of the planned analyses and the publishing of a summary of the results timely after completion of the study. The quality of the data can be improved by using standardized case report forms (CRF) and the CRF should be reviewed and tested before start of study by some participants. A source data verification (SDV) should be performed in randomly selected centres – in between 2% and 5% of the centres depending on the number of participating centres. Before start of statistical analysis a statistical analysis plan (SAP) should be created. The use of standardized tables and figures is highly recommended. The basis of the report writing should be the STROBE-statement “Strengthening the Reporting of Observational studies in Epidemiology Initiative” containing a checklist of 22 points to be covered in the report. The development of own standard operating procedures (SOP) describing the processes during planning, conduct and evaluation of a non-interventional study as well as the quality management and the regular training of all involved people is also highly recommended. All accompanying measures to improve or to keep the quality of the NIS should not violate the concept of non-intervention. German Medical Science GMS Publishing House 2009-11-09 /pmc/articles/PMC2778825/ /pubmed/19949447 http://dx.doi.org/10.3205/000088 Text en Copyright © 2009 Theobald et al. http://creativecommons.org/licenses/by-nc-nd/3.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.en). You are free to copy, distribute and transmit the work, provided the original author and source are credited. |
spellingShingle | Article Theobald, Karlheinz Capan, Müge Herbold, Marlis Schinzel, Stefan Hundt, Ferdinand Quality assurance in non-interventional studies |
title | Quality assurance in non-interventional studies |
title_full | Quality assurance in non-interventional studies |
title_fullStr | Quality assurance in non-interventional studies |
title_full_unstemmed | Quality assurance in non-interventional studies |
title_short | Quality assurance in non-interventional studies |
title_sort | quality assurance in non-interventional studies |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2778825/ https://www.ncbi.nlm.nih.gov/pubmed/19949447 http://dx.doi.org/10.3205/000088 |
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