Health RisksNCT03798990
Reduce Speed Limits From 90km/h to 80 km/h on French Roads: Impact on Mortality
An observational study of Health Risks and Death, run by Centre d'études et d'expertise sur les risques, l'environnement, la mobilité et l'aménagement at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Health Risks, Death
- How many people
- 80,000,000 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All the population who circulate on French non-motorway non-urban roads during the period of the study may be potentially concerned
Who may be able to join
- people who circulate on French non-motorway non-urban roads during the period of the study
- any person who dies in a road accident on this network during the period of the study, who either dies instantly or within 30 days of the accident, due to the consequences of the accident
Who cannot join
- all persons involved in an accident on a private road
- all persons involved in a road accident without a motor vehicle
Trial locations and contacts
1 site in 1 country.
About this study
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 "Before and After" the Reduction of Speed Limits.
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.
Read more
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).
Read the detailed description
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.
- Conditions
- Health Risks, Death
- Keywords
- Speed, Road safety
- Medical subject headings
- Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| users of French roads | all road users circulating on French roads outside over-seas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the number of fatalities in road accidents before and after the implementation of the measure
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)
Measured: before period: 2015-2017 / after period: July 2018- June 2019
Secondary outcomes (1)
Sub-groups analysis of road fatalities, by type of road users, before and after the implementation of the measure
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)
Measured: before period: 2015-2017 / after period: July 2018- June 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study startJan 2015
- Primary completionJul 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health RisksStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Other
- Enrolment
- 80,000,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre d'études et d'expertise sur les risques, l'environnement, la mobilité et l'aménagement
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marine Millot, PhD, Study director, Centre d'études et d'expertise sur les risques, l'environnement, la mobilité et l'aménagement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03798990
- Sponsor's protocol ID
- 2018-12
- Status last verified
- Jan 2019
- First submitted
- 21 Dec 2018
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 "Before and After" the Reduction of Speed Limits.
- ClinicalTrials.gov ID
- NCT03798990
- Acronym / sponsor ID
- 2018-12
- Conditions
- Health Risks, Death
- Keywords
- Speed, Road safety
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80,000,000 participants (estimated)
- Lead sponsor
- Centre d'études et d'expertise sur les risques, l'environnement, la mobilité et l'aménagementUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 10 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| users of French roads | – | –all road users circulating on French roads outside over-seas |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All the population who circulate on French non-motorway non-urban roads during the period of the study may be potentially concerned
Key inclusion criteria (2 listed)
- people who circulate on French non-motorway non-urban roads during the period of the study
- any person who dies in a road accident on this network during the period of the study, who either dies instantly or within 30 days of the accident, due to the consequences of the accident
Key exclusion criteria (2 listed)
- all persons involved in an accident on a private road
- all persons involved in a road accident without a motor vehicle
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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)
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marine Millot, PhD study director
Centre d'études et d'expertise sur les risques, l'environnement, la mobilité et l'aménagement
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Risks and Death, run by Centre d'études et d'expertise sur les risques, l'environnement, la mobilité et l'aménagement at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Chupin (33 4 72 14 31 52, david.chupin@cerema.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2019.