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Evaluation of clinical trials by Ethics Committees in Germany--results and a comparison of two surveys performed among members of the German Association of Research-Based Pharmaceutical Companies (vfa).
Ger Med Sci. 2015; 13:Doc02.GM

Abstract

OBJECTIVE

The objective of this project was to evaluate the quality and quantity of initial applications for a clinical trial according to § 7 of the German Good Clinical Practice (GCP) ordinance (German: GCP-Verordnung, GCP-V), the quality of evaluations of those applications by Ethics Committees (ECs)/Investigational Review Boards (IRBs) in Germany as well as the pattern of EC objections in their reasoned opinions (vote). In order to identify a change over time, the results of the present survey were also compared with a survey performed in 2008.

METHODS

Based on reasoned opinions issued by the respective EC in charge of the coordinating principle investigator (coordinating EC) in 2011, a written survey among members of the German Association of Research-Based Pharmaceutical Companies (vfa) was conducted in 2012. The answers to the questionnaire were analyzed descriptively. Since the data set collected in 2011 was structurally identical with the data set gained in 2007 both surveys were compared.

RESULTS

Of the 24 companies represented on the vfa Clinical Research/Quality Assurance Subcommittee, 75% (18) took part in the survey. Survey evaluation was based on a total of 251 applications of these 18 companies submitted to 43 ECs. These account for about 21% of 1,214 applications for authorization of commercial and non-commercial phase I-IV clinical trials submitted to the regulatory authorities (BfArM and PEI) in 2011. In comparison to 2007, a lower amount of applications (n=251 in 2011 vs. n=288 in 2007) was submitted to a slightly higher number of ECs (43 in 2011 vs. 40 in 2007). The amount of objections increased by 21% from 1,299 (2007) to 1,574 (2011) resulting in an average of 4.5 (2007) vs. 6.3 (2011) objections per application. Overall, the analysis of both formal and content related objections revealed almost the same pattern as in the previous survey. In total, the most frequent objections applied to the patient information and consent form followed in descending order by trial protocol content, miscellaneous, other application documents pursuant to § 7 (2) and (3) GCP-V, formal deficiencies pursuant to § 8 (1) GCP-V, and investigator and site qualifications. A trend towards a slightly increased rate of objections concerning patient information and consent form (+4%) and a minimal decrease in objections concerning investigator and site qualifications (-2%) was observed. As in 2007, about 1 in 6 applications was still incomplete with formal objections. Whilst the proportion of study applications with objections related to the patient information and consent form (+7.2%), the trial protocol content (+11.6%), and documents according to § 7 (2) and (3) GCP-V (+11.8%) increased in 2011 compared to 2007, the amount of study applications with objections related to the investigator and site qualifications decreased by 6.3%.

CONCLUSIONS

The majority of findings with respect to quantity, quality and main focus of objections reported in the first survey in 2008 were also found in 2012, indicating a shared understanding of applicable measures and criteria by sponsors and ECs on how to ensure patient rights and well-being, data integrity, and high quality documentation in clinical trials.

Authors+Show Affiliations

Lilly Deutschland GmbH, Bad Homburg, Germany.Bristol-Myers-Squibb GmbH & Co. KGaA, Munich, Germany.Lilly Deutschland GmbH, Bad Homburg, Germany.Boehringer Ingelheim GmbH, Ingelheim, Germany.

Pub Type(s)

Comparative Study
Journal Article

Language

eng

PubMed ID

25698912

Citation

Russ, Hagen, et al. "Evaluation of Clinical Trials By Ethics Committees in Germany--results and a Comparison of Two Surveys Performed Among Members of the German Association of Research-Based Pharmaceutical Companies (vfa)." German Medical Science : GMS E-journal, vol. 13, 2015, pp. Doc02.
Russ H, Busta S, Jost B, et al. Evaluation of clinical trials by Ethics Committees in Germany--results and a comparison of two surveys performed among members of the German Association of Research-Based Pharmaceutical Companies (vfa). Ger Med Sci. 2015;13:Doc02.
Russ, H., Busta, S., Jost, B., & Bethke, T. D. (2015). Evaluation of clinical trials by Ethics Committees in Germany--results and a comparison of two surveys performed among members of the German Association of Research-Based Pharmaceutical Companies (vfa). German Medical Science : GMS E-journal, 13, Doc02. https://doi.org/10.3205/000206
Russ H, et al. Evaluation of Clinical Trials By Ethics Committees in Germany--results and a Comparison of Two Surveys Performed Among Members of the German Association of Research-Based Pharmaceutical Companies (vfa). Ger Med Sci. 2015;13:Doc02. PubMed PMID: 25698912.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of clinical trials by Ethics Committees in Germany--results and a comparison of two surveys performed among members of the German Association of Research-Based Pharmaceutical Companies (vfa). AU - Russ,Hagen, AU - Busta,Susanne, AU - Jost,Bertfried, AU - Bethke,Thomas D, Y1 - 2015/01/27/ PY - 2014/10/27/received PY - 2014/12/23/revised PY - 2015/2/21/entrez PY - 2015/2/24/pubmed PY - 2015/11/18/medline KW - Ethics Committees KW - application procedure KW - clinical trials KW - formal and content-related objections SP - Doc02 EP - Doc02 JF - German medical science : GMS e-journal JO - Ger Med Sci VL - 13 N2 - OBJECTIVE: The objective of this project was to evaluate the quality and quantity of initial applications for a clinical trial according to § 7 of the German Good Clinical Practice (GCP) ordinance (German: GCP-Verordnung, GCP-V), the quality of evaluations of those applications by Ethics Committees (ECs)/Investigational Review Boards (IRBs) in Germany as well as the pattern of EC objections in their reasoned opinions (vote). In order to identify a change over time, the results of the present survey were also compared with a survey performed in 2008. METHODS: Based on reasoned opinions issued by the respective EC in charge of the coordinating principle investigator (coordinating EC) in 2011, a written survey among members of the German Association of Research-Based Pharmaceutical Companies (vfa) was conducted in 2012. The answers to the questionnaire were analyzed descriptively. Since the data set collected in 2011 was structurally identical with the data set gained in 2007 both surveys were compared. RESULTS: Of the 24 companies represented on the vfa Clinical Research/Quality Assurance Subcommittee, 75% (18) took part in the survey. Survey evaluation was based on a total of 251 applications of these 18 companies submitted to 43 ECs. These account for about 21% of 1,214 applications for authorization of commercial and non-commercial phase I-IV clinical trials submitted to the regulatory authorities (BfArM and PEI) in 2011. In comparison to 2007, a lower amount of applications (n=251 in 2011 vs. n=288 in 2007) was submitted to a slightly higher number of ECs (43 in 2011 vs. 40 in 2007). The amount of objections increased by 21% from 1,299 (2007) to 1,574 (2011) resulting in an average of 4.5 (2007) vs. 6.3 (2011) objections per application. Overall, the analysis of both formal and content related objections revealed almost the same pattern as in the previous survey. In total, the most frequent objections applied to the patient information and consent form followed in descending order by trial protocol content, miscellaneous, other application documents pursuant to § 7 (2) and (3) GCP-V, formal deficiencies pursuant to § 8 (1) GCP-V, and investigator and site qualifications. A trend towards a slightly increased rate of objections concerning patient information and consent form (+4%) and a minimal decrease in objections concerning investigator and site qualifications (-2%) was observed. As in 2007, about 1 in 6 applications was still incomplete with formal objections. Whilst the proportion of study applications with objections related to the patient information and consent form (+7.2%), the trial protocol content (+11.6%), and documents according to § 7 (2) and (3) GCP-V (+11.8%) increased in 2011 compared to 2007, the amount of study applications with objections related to the investigator and site qualifications decreased by 6.3%. CONCLUSIONS: The majority of findings with respect to quantity, quality and main focus of objections reported in the first survey in 2008 were also found in 2012, indicating a shared understanding of applicable measures and criteria by sponsors and ECs on how to ensure patient rights and well-being, data integrity, and high quality documentation in clinical trials. SN - 1612-3174 UR - https://www.unboundmedicine.com/medline/citation/25698912/Evaluation_of_clinical_trials_by_Ethics_Committees_in_Germany__results_and_a_comparison_of_two_surveys_performed_among_members_of_the_German_Association_of_Research_Based_Pharmaceutical_Companies__vfa__ L2 - https://doi.org/10.3205/000206 DB - PRIME DP - Unbound Medicine ER -