The Study Focus on no Specific ConditionNCT04263805
A Vignette-based Randomized Controlled Trial to Evaluate the Impact of Research Climate on Research Practices of Doctoral Students
A study testing Vignette with emphasis on research climate in people with The Study Focus on no Specific Condition, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This study aims to evaluate the impact of research climate on PhD students' research practice (i.e., an environment where their peer (i.e., a post-doc researcher) had detrimental practice in a similar situation) Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- The Study Focus on no Specific Condition
- What is being tested?
- Vignette with emphasis on research climate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2020to 31 Dec 2020
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PhD students in biomedical disciplines
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
France1 site
Centre d'Epidémiologie Clinique, hôpital Hôtel Dieu, Assistance Publique-Hôpitaux de Paris
Paris, 75181
About this study
Official title: A Vignette-based Randomized Controlled Trial to Evaluate the Impact of Research Climate on Research Practices of Doctoral Students Facing Dilemma Situations
This study aims to evaluate the impact of research climate on PhD students' research practice (i.e., an environment where their peer (i.e., a post-doc researcher) had detrimental practice in a similar situation)
Read the detailed description
PhD students are the next generation of researchers and will present the field in the future. However, several environmental factors might influence their research practice. In this study, the investigators will evaluate the impact of research climate on PhD students' research practice (exposure to an environment where their peers commit a detrimental practice).
Objective: To evaluate the impact of research climate on PhD students' research practice
Design: A randomized controlled trial
- Intervention: Participants will be shown two case vignettes describing dilemma situations in research reported with and without research climate factor.
- Participants: The participants will be PhD students in all biomedical disciplines.
- Sample size will be 300 participants
- Primary outcome: In each vignette, participants will have to indicate which solution they prefer on a semantic differential scale, rated from - 5 to -1 (preference for solution A) and from 1 to 5 (preference for solution B). Participants will be forced to make a choice between the 2 solutions. The primary outcome will be the mean preference score.
- This study is approved by ethics review regulations by INSERM (CEEI-IRB): IRB00003888
- Conditions
- The Study Focus on no Specific Condition
- Being tested
- Vignette with emphasis on research climate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vignette with emphasis on research climateOther
A vignette describing a dilemma situation for a researcher (e.g. adding an honorary author) with or without a research environment factor (i.e. an environment where other researchers commit detrimental research practice)
| Study group | Role | What they receive |
|---|---|---|
| Vignette with research climate | Experimental | Participants in this arm will receive vignettes describing a dilemma situation in research (e.g adding honorary author) with additional sentence describing research climate (i.e. an environment where their peer had detrimental practice in a similar situation) Receives: Other: Vignette with emphasis on research climate |
| Vignette without research climate | Active comparator | Participants in this arm will receive vignettes describing a dilemma situation in research without the additional sentence describing research climate Receives: Other: Vignette with emphasis on research climate |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean preference score
In each vignette, participants will have to indicate which solution they prefer on a semantic differential scale, rated from - 5 to -1 (preference for solution A) and from 1 to 5 (preference for solution B).
Measured: Immediate assessment
Secondary outcomes (1)
proportion of students who chose the detrimental research practice (DRP)
Proportion of students rated from -5 to -1 for the DRP.
Measured: Immediate assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start1 Feb 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for The Study Focus on no Specific ConditionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04263805
- Sponsor's protocol ID
- ISB-013
- Status last verified
- Jan 2020
- First submitted
- 7 Feb 2020
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nguyen VT, Sharp MK, Superchi C, Baron G, Glonti K, Blanco D, Olsen M, Vo Tat TT, Olarte Parra C, Neveol A, Hren D, Ravaud P, Boutron I. Biomedical doctoral students' research practices when facing dilemmas: two vignette-based randomized control trials. Sci Rep. 2023 Sep 29;13(1):16371. doi: 10.1038/s41598-023-42121-1.
PubMed 37773192
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Vignette-based Randomized Controlled Trial to Evaluate the Impact of Research Climate on Research Practices of Doctoral Students Facing Dilemma Situations
- ClinicalTrials.gov ID
- NCT04263805
- Acronym / sponsor ID
- ISB-013
- Conditions
- The Study Focus on no Specific Condition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Feb 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 11 Feb 2020 (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.
This study aims to evaluate the impact of research climate on PhD students' research practice (i.e., an environment where their peer (i.e., a post-doc researcher) had detrimental practice in a similar situation)
Detailed description
PhD students are the next generation of researchers and will present the field in the future. However, several environmental factors might influence their research practice. In this study, the investigators will evaluate the impact of research climate on PhD students' research practice (exposure to an environment where their peers commit a detrimental practice).
Objective: To evaluate the impact of research climate on PhD students' research practice
Design: A randomized controlled trial
- Intervention: Participants will be shown two case vignettes describing dilemma situations in research reported with and without research climate factor.
- Participants: The participants will be PhD students in all biomedical disciplines.
- Sample size will be 300 participants
- Primary outcome: In each vignette, participants will have to indicate which solution they prefer on a semantic differential scale, rated from - 5 to -1 (preference for solution A) and from 1 to 5 (preference for solution B). Participants will be forced to make a choice between the 2 solutions. The primary outcome will be the mean preference score.
- This study is approved by ethics review regulations by INSERM (CEEI-IRB): IRB00003888
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vignette with research climate | Experimental | Other: Vignette with emphasis on research climateParticipants in this arm will receive vignettes describing a dilemma situation in research (e.g adding honorary author) with additional sentence describing research climate (i.e. an environment where their peer had detrimental practice in a similar situation) |
| Vignette without research climate | Active comparator | Other: Vignette with emphasis on research climateParticipants in this arm will receive vignettes describing a dilemma situation in research without the additional sentence describing research climate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- PhD students in biomedical disciplines
Key exclusion criteria (1 listed)
- NA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vignette with emphasis on research climateA vignette describing a dilemma situation for a researcher (e.g. adding an honorary author) with or without a research environment factor (i.e. an environment where other researchers commit detrimental research practice) | Other | Vignette with research climate, Vignette without research climate |
Primary outcome
mean preference score
Time frame: Immediate assessment
In each vignette, participants will have to indicate which solution they prefer on a semantic differential scale, rated from - 5 to -1 (preference for solution A) and from 1 to 5 (preference for solution B).
1 secondary outcome
proportion of students who chose the detrimental research practice (DRP)
Time frame: Immediate assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Derived from this study: PubMed 37773192Nguyen VT, Sharp MK, Superchi C, Baron G, Glonti K, Blanco D, Olsen M, Vo Tat TT, Olarte Parra C, Neveol A, Hren D, Ravaud P, Boutron I. Biomedical doctoral students' research practices when facing dilemmas: two vignette-based randomized control trials. Sci Rep. 2023 Sep 29;13(1):16371. doi: 10.1038/s41598-023-42121-1.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vignette with emphasis on research climate in people with The Study Focus on no Specific Condition, run by Assistance Publique - Hôpitaux de Paris 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 1 inclusion and 1 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 11 Feb 2020. 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 Isabelle BOUTRON, Pr (+33 (0)1.42.34.78.33, isabelle.boutron@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean preference score (time frame: Immediate assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04263805, which also lists 1 linked publication.
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 11 Feb 2020; AzTrials last refreshed its copy on 28 Oct 2026.