<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03798990</url>
  </required_header>
  <id_info>
    <org_study_id>2018-12</org_study_id>
    <nct_id>NCT03798990</nct_id>
  </id_info>
  <brief_title>Reduce Speed Limits From 90km/h to 80 km/h on French Roads: Impact on Mortality</brief_title>
  <official_title>Reduce Speed Limits From 90km/h to 80 km/h on French Two-way Roads Without Central Separator: the Number of Traffic Related Fatalities on the Network Concerned &quot;Before and After&quot; the Reduction of Speed Limits.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre d'études et d'expertise sur les risques, l'environnement, la mobilité et l'aménagement</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre d'études et d'expertise sur les risques, l'environnement, la mobilité et l'aménagement</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      On the first July 2018, the French government lowered the maximum authorized speeds on&#xD;
      two-way roads without a central separator from 90 km/h to 80 km/h. The network concerned&#xD;
      represents approximately 400 000 km of roads outside the built-up area, accounting for 55% of&#xD;
      road deaths.&#xD;
&#xD;
      The objective of the measure is to reduce the number of deaths on the roads concerned by&#xD;
      encouraging the reduction of the average speed practiced by drivers.&#xD;
&#xD;
      The analysis deals with a comparison of the number of killed persons on the network&#xD;
      concerned, before and after the reduction of the speed limits. The &quot;before&quot; period is&#xD;
      2015-2017. The &quot;after&quot; period is from July 2018 to June 2019.&#xD;
&#xD;
      The data used are extracted from the national bodily injury accident file (BAAC). The police&#xD;
      fills this file for each road accidents occurring on a road open to public traffic and&#xD;
      causing at least one victim (i.e., one user requiring medical care and involving at least one&#xD;
      vehicle).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This measure was intended general and concerns a type of roads in its entirety. The rest of&#xD;
      the road network is too heterogeneous (urban, highways ...), leading to an accidentology very&#xD;
      far in terms of severity, users concerned and families of accidents to allow the&#xD;
      establishment of control groups that would not be affected by a reduction in the speed limit.&#xD;
      As a result, the principle of an assessment of &quot;before-and-after&quot; effects has been retained.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Anticipated">January 2020</completion_date>
  <primary_completion_date type="Anticipated">July 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evolution of the number of fatalities in road accidents before and after the implementation of the measure</measure>
    <time_frame>before period: 2015-2017 / after period: July 2018- June 2019</time_frame>
    <description>the number of fatalities in road accidents on non-motorway non-urban roads during the period July 2018-June 2019 (&quot;after&quot; the measure) compared to the number of fatalities during the period 2015-2017 (&quot;before&quot; the measure)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sub-groups analysis of road fatalities, by type of road users, before and after the implementation of the measure</measure>
    <time_frame>before period: 2015-2017 / after period: July 2018- June 2019</time_frame>
    <description>For each type of road users, the number of fatalities in road accidents on non-motorway non-urban roads during the period July 2018-June 2019 (&quot;after&quot; the measure) compared to the number of fatalities during the period 2015-2017 (&quot;before&quot; the measure)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">80000000</enrollment>
  <condition>Health Risks</condition>
  <condition>Death</condition>
  <arm_group>
    <arm_group_label>users of French roads</arm_group_label>
    <description>all road users circulating on French roads outside over-seas</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All the population who circulate on French non-motorway non-urban roads during the period&#xD;
        of the study may be potentially concerned&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  people who circulate on French non-motorway non-urban roads during the period of the&#xD;
             study&#xD;
&#xD;
          -  any person who dies in a road accident on this network during the period of the study,&#xD;
             who either dies instantly or within 30 days of the accident, due to the consequences&#xD;
             of the accident&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  all persons involved in an accident on a private road&#xD;
&#xD;
          -  all persons involved in a road accident without a motor vehicle&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marine Millot, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Centre d'études et d'expertise sur les risques, l'environnement, la mobilité et l'aménagement</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>David Chupin</last_name>
    <phone>33 4 72 14 31 52</phone>
    <email>david.chupin@cerema.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cerema</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David Chupin</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>January 9, 2019</last_update_submitted>
  <last_update_submitted_qc>January 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Speed</keyword>
  <keyword>Road safety</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03798990
org study id: 2018-12
nct id: NCT03798990
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
On the first July 2018, the French government lowered the maximum authorized speeds on
      two-way roads without a central separator from 90 km/h to 80 km/h. The network concerned
      represents approximately 400 000 km of roads outside the built-up area, accounting for 55% of
      road deaths.

      The objective of the measure is to reduce the number of deaths on the roads concerned by
      encouraging the reduction of the average speed practiced by drivers.

      The analysis deals with a comparison of the number of killed persons on the network
      concerned, before and after the reduction of the speed limits. The "before" period is
      2015-2017. The "after" period is from July 2018 to June 2019.

      The data used are extracted from the national bodily injury accident file (BAAC). The police
      fills this file for each road accidents occurring on a road open to public traffic and
      causing at least one victim (i.e., one user requiring medical care and involving at least one
      vehicle).
This measure was intended general and concerns a type of roads in its entirety. The rest of
      the road network is too heterogeneous (urban, highways ...), leading to an accidentology very
      far in terms of severity, users concerned and families of accidents to allow the
      establishment of control groups that would not be affected by a reduction in the speed limit.
      As a result, the principle of an assessment of "before-and-after" effects has been retained.
observational model: Ecologic or Community
time perspective: Other
measure: Evolution of the number of fatalities in road accidents before and after the implementation of the measure
time frame: before period: 2015-2017 / after period: July 2018- June 2019
description: the number of fatalities in road accidents on non-motorway non-urban roads during the period July 2018-June 2019 ("after" the measure) compared to the number of fatalities during the period 2015-2017 ("before" the measure)
measure: Sub-groups analysis of road fatalities, by type of road users, before and after the implementation of the measure
time frame: before period: 2015-2017 / after period: July 2018- June 2019
description: For each type of road users, the number of fatalities in road accidents on non-motorway non-urban roads during the period July 2018-June 2019 ("after" the measure) compared to the number of fatalities during the period 2015-2017 ("before" the measure)
arm group label: users of French roads
description: all road users circulating on French roads outside over-seas
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Marine Millot, PhD
role: Study Director
affiliation: Centre d'études et d'expertise sur les risques, l'environnement, la mobilité et l'aménagement
last name: David Chupin
phone: 33 4 72 14 31 52
email: david.chupin@cerema.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor