The Study Focus on no Specific ConditionNCT04263506
A Vignette-based Randomized Controlled Trial to Evaluate the Impact of Supervisor's Role on Research Practices of Doctoral Students
A study testing Vignette with emphasis on supervisor's opinion in people with The Study Focus on no Specific Condition, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
This study aims to evaluate the influence of supervisors on PhD students' research practice (i.e., an environment where there is a lack of opposition to detrimental research practice from the supervisor) Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- The Study Focus on no Specific Condition
- What is being tested?
- Vignette with emphasis on supervisor's opinion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2020to 1 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PhD students in biomedical sciences
Who cannot join
- NA
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Vignette-based Randomized Controlled Trial to Evaluate the Impact of Supervisor's Role on Research Practices of Doctoral Students Facing Dilemma Situations
This study aims to evaluate the influence of supervisors on PhD students' research practice (i.e., an environment where there is a lack of opposition to detrimental research practice from the supervisor)
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, we will evaluate the influence of supervisors on PhD students' research practice (an environment where there is a lack of opposition to detrimental research practice from the supervisor).
Objective: To evaluate the influence of supervisors 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 the role of the supervisor.
- 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 supervisor's opinion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vignette with emphasis on supervisor's opinionOther
A vignette describing a dilemma situation for a researcher (e.g. adding an honorary author) with or without the description of supervisor's advice that does not oppose to detrimental research practice (i.e. the supervisor is fine with whatever the PhD student decides in the dilemma).
| Study group | Role | What they receive |
|---|---|---|
| Vignette with supervisor's opinion | Experimental | Participants in this arm will receive vignettes with an additional sentence describing supervisor's opinion (i.e. supervisor does not oppose to detrimental research practice) Receives: Other: Vignette with emphasis on supervisor's opinion |
| Vignette without supervisor's opinion | Active comparator | Participants in this arm will receive vignettes without an additional sentence describing supervisor's opinion. Receives: Other: Vignette with emphasis on supervisor's opinion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean preference score
In each vignette, we will ask participants, what would you do if you are in the place of the character in the 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). We will calculate the mean preference score
Measured: Immediate assessment
Secondary outcomes (1)
Proportion of students who chose the detrimental research practice
Proportion of students who made choices rated from -5 to -1
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 posted10 Feb 2020
- Study start1 Mar 2020 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion1 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
- NCT04263506
- Sponsor's protocol ID
- ISB-014
- Status last verified
- Jan 2020
- First submitted
- 7 Feb 2020
- Last updated
- 10 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 10 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 Supervisor's Role on Research Practices of Doctoral Students Facing Dilemma Situations
- ClinicalTrials.gov ID
- NCT04263506
- Acronym / sponsor ID
- ISB-014
- 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 Mar 2020 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 10 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 influence of supervisors on PhD students' research practice (i.e., an environment where there is a lack of opposition to detrimental research practice from the supervisor)
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, we will evaluate the influence of supervisors on PhD students' research practice (an environment where there is a lack of opposition to detrimental research practice from the supervisor).
Objective: To evaluate the influence of supervisors 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 the role of the supervisor.
- 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 supervisor's opinion | Experimental | Other: Vignette with emphasis on supervisor's opinionParticipants in this arm will receive vignettes with an additional sentence describing supervisor's opinion (i.e. supervisor does not oppose to detrimental research practice) |
| Vignette without supervisor's opinion | Active comparator | Other: Vignette with emphasis on supervisor's opinionParticipants in this arm will receive vignettes without an additional sentence describing supervisor's opinion. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- PhD students in biomedical sciences
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 supervisor's opinionA vignette describing a dilemma situation for a researcher (e.g. adding an honorary author) with or without the description of supervisor's advice that does not oppose to detrimental research practice (i.e. the supervisor is fine with whatever the PhD student decides in the dilemma). | Other | Vignette with supervisor's opinion, Vignette without supervisor's opinion |
Primary outcome
Mean preference score
Time frame: Immediate assessment
In each vignette, we will ask participants, what would you do if you are in the place of the character in the 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). We will calculate the mean preference score
1 secondary outcome
Proportion of students who chose the detrimental research practice
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 10 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.
Questions about this trial
What is this clinical trial studying?
A study testing Vignette with emphasis on supervisor's opinion in people with The Study Focus on no Specific Condition, run by Assistance Publique - Hôpitaux de Paris.
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 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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, Professor (+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 NCT04263506, 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 10 Feb 2020.