[fusion_builder_container hundred_percent="no" equal_height_columns="no" menu_anchor="" hide_on_mobile="small-visibility,medium-visibility,large-visibility" class="" id="" background_color="" background_image="" background_position="center center" background_repeat="no-repeat" fade="no" background_parallax="none" parallax_speed="0.3" video_mp4="" video_webm="" video_ogv="" video_url="" video_aspect_ratio="16:9" video_loop="yes" video_mute="yes" overlay_color="" video_preview_image="" border_color="" border_style="solid" padding_top="" padding_bottom="" padding_left="" padding_right="" type="legacy"][fusion_builder_row][fusion_builder_column type="1_1" layout="1_1" background_position="left top" background_color="" border_color="" border_style="solid" border_position="all" spacing="yes" background_image="" background_repeat="no-repeat" padding_top="" padding_right="" padding_bottom="" padding_left="" margin_top="0px" margin_bottom="0px" class="" id="" animation_type="" animation_speed="0.3" animation_direction="left" hide_on_mobile="small-visibility,medium-visibility,large-visibility" center_content="no" last="true" min_height="" hover_type="none" link="" border_sizes_top="" border_sizes_bottom="" border_sizes_left="" border_sizes_right="" type="1_1" first="true"][fusion_text]Researchers, stakeholders, and corporate interests reached consensus in 2014 that there needed to be greater harmony of the rules for conducting clinical trials throughout the EU. While there were previous guidelines in place (namely the EU Clinical Trials Directive, which was approved in 2001), member states had interpreted and implemented the rules differently throughout the EU, resulting in increased costs, delays, and various administrative and regulatory burdens.
In response, the EU Clinical Trial Regulation (EU-CTR[1]) entered into force on June 16, 2014. The intention of the regulation is to, “create an environment favourable to conducting clinical trials, with the highest standards of patient safety, for all EU member states”[2]. The regulation includes a number of key provisions:
- Authorization procedure for clinical trials based on a single submission dossier
- Assessment procedure for singular decisions on all aspects
- Rules to guide the protection of subjects
- Transparency requirements
- Detailed safety provisions
- Indemnity provisions
- Guidelines to support increased multinational trials
Additional transparency requirements clarify the protocol for publishing clinical trial results, and will provide functionality to support such publication through the EU portal and database. The regulation supports the idea that clinical trial study reports should not be confidential, and that instead this information should be made more readily available to the public.
Transparency in the EU
One of the key tenets of the EU-CTR is transparency[3]. The regulation aims to make all information on the EU database publicly available, unless its confidentiality is found to be reasonable under the following 4 conditions:
- Protecting personal data
- Protecting confidential communication between EU member states
- Protecting commercially confidential information
- Ensuring effective supervision of a trial
Safety Reporting
The regulation makes further specifications around the rules for safety reporting:
- Not all adverse events may be reported or recorded
- Clinical trials involving more than one investigational medical product only need to submit a single safety report
- Suspected Unexpected Serious Adverse Reactions (SUSAR) can be reported to the database.
The Changing Landscape of Clinical Trial Communication
The global medical community has long been moving towards a more transparent landscape, in which data from clinical trials is more readily available to the public. Regulations supporting this assertion have begun popping up across the world, and in order to remain compliant with ongoing legislative changes, pharmaceutical companies need to remain focused on creating a future infrastructure that allows for the publication of a wider range of clinical trial data.
Experts in Medical Communications
At Six Degrees Medical, we are global leaders in translating complex science into knowledge. We understand that the process of introducing a new drug to treat diseases requires not only compliance with regulations such as the EU-CTR, but also high level communication. For over a decade, our team has assisted pharmaceutical clients in optimizing their brand, and streamlining their communications. To learn more about how Six Degrees Medical can improve your company’s communications, call us today at (647) 725-0073, or email us at info@sixdegreesmed.com.
[1] Pharmafile, “What You Need to Know About the EU Clinical Trial Regulation”, http://var/web/site/public_html.pharmafile.com/news/198121/what-you-need-know-about-eu-clinical-trial-regulation
[2] European Commission, “Clinical Trials- General Information”, https://ec.europa.eu/health/human-use/clinical-trials/information_en
[3] European Commission, “Clinical Trials- Regulation EU No. 536/2014”, https://ec.europa.eu/health/human-use/clinical-trials/regulation_en[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container]