The Study Will Focus on no Specific ConditionsREGISTNCT01658254
Posting of Basic Results of Clinical Trials
A study testing survey by email in people with The Study Will Focus on no Specific Conditions, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The gap between the high number of registered trials and the few ones where results were available (in registries or in journals) has been identified as a major problem distorting the scientific evidence available. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- The Study Will Focus on no Specific Conditions
- What is being tested?
- survey by email
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 379 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2012to May 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Interventional studies of drugs, biological or devices
- Studies which are closed and either completed or active but not recruiting anymore
- Studies with at least one site in the USA
- Studies registered as phase IV
- Studies with a primary completion date or, if missing, a completion date ranging from October 2008 to January 2011
- Studies without posted results on the registry
Who cannot join
- Studies which are still recruiting
- Studies which are either withdrawn or suspended
- Studies which primary completion date is less than one year
- Studies without a given primary completion date or completion date
- Studies involving interventions which are neither drugs or biologics nor devices will be excluded
- Studies whose summary results are posted
- Studies without indication on the sponsor or the principal investigator
- Studies whom email address of the sponsor or the principal investigator could not be found in a publicly accessible site
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cohort Randomized Controlled Trial Evaluating the Effect of Sending a Reminder to Responsible Parties of Clinical Trials in the Posting of Basic Results Onto ClinicalTrials.Gov
The gap between the high number of registered trials and the few ones where results were available (in registries or in journals) has been identified as a major problem distorting the scientific evidence available. As a consequence, the FDAAA (Food and Drug Administration Amendments Act) added on September 27, 2007 a requirements policy regarding publication of summary results on the publicly accessible registry ClinicalTrials.gov. Reporting of summary results is required for "applicable clinical trials" no later than one year after the "primary completion date", i.e. the date of collection of primary outcome data on the last patient to be enrolled. 'Applicable clinical trials', is the term used in the FDAAA to designate trials that may be subject to the registration and reporting requirements.
Not complying with the reporting requirements can result in penalties, such as withholding of National Institute of Health grant or funding and civil monetary penalties of up to $10,000 a day. Despite the possibility of incurring penalties for not complying with the posting requirement, compliance remains globally poor.
In this current study, the primary objective will be to test the hypothesis that sending an email looking as a survey, reminding the necessity of posting results to the trials' responsible parties registered in ClinicalTrials.gov and subject to mandatory reporting but not complying with it, will increase the results posting rate.
Read the detailed description
According to the recommendation of 2005 by International Committee of Medical Journal Editors (ICMJE), clinical trials must be registered before enrolment of the first patient in a free registry recognized by the World Health Organization (WHO). The goal is to improve transparency of clinical research. The ClinicalTrials.gov trial registry, initiated subsequently to the US Food and Drug Administration Modernization Act (FDAMA) in 1997, is the widest used registry, and contains more than 121 000 studies located in 179 countries (data of March 1, 2012).
The gap between the high number of registered trials and the few ones where results were available (in registries or in journals) has been identified as a major problem distorting the scientific evidence available, and inducing publication bias. As a consequence, the FDAAA (Food and Drug Administration Amendments Act) added on September 27, 2007 a requirements policy regarding publication of summary results on the publicly accessible registry ClinicalTrials.gov. Reporting of summary results is required for "applicable clinical trials" no later than one year after the "primary completion date", i.e. the date of collection of primary outcome data on the last patient to be enrolled. 'Applicable clinical trials', is the term used in the FDAAA to designate trials that may be subject to the registration and reporting requirements. They include interventional controlled studies registered after the enactment of the FDAAA (or ongoing at this date), involving drugs, biologics, or devices (only after FDA-approved for any use), regardless of sponsorship; phases II through IV; located at least in one U.S. site.
The entity or individual responsible for registering and posting basic results is called the 'responsible party'. This term refers to the sponsor of the study or the principal investigator of the study, if so designated by a sponsor, grantee, contractor, or awardee.
In certain circumstances, delayed submission of results information with certification can be allowed. Not complying with the reporting requirements can result in penalties, such as withholding of National Institute of Health grant or funding and civil monetary penalties of up to $10,000 a day. Despite the possibility of incurring penalties for not complying with the posting requirement, compliance remains globally poor.
In this current study, the primary objective will be to test the hypothesis that sending an email asking to answer a survey, reminding the necessity of posting results to the trials' responsible parties registered in ClinicalTrials.gov and subject to mandatory reporting but not complying with it, will increase the results posting rate.
The secondary objective will be to investigate the reasons given by the trials' responsible parties for not posting summary results onto the registry.
- Being tested
- survey by email
- Keywords
- Clinical trials, Basic results, Registry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
survey by emailOther
The intervention consists in an email to be sent to the sponsor and/or principal investigator of randomly assigned trials. This email will notify them that their trial's primary completion date is over a year old and will ask the reasons why they have not posted results on the registry. Several reasons will be proposed, and investigators or sponsors will be asked to reply by sending back an email or through a website where the same questions will appear. A follow-up email will systematically be sent 7 days after, with similar content (appendix2). The emails will be sent as direct emails, without attached files, with the edit subject "Posting basic results". The controlled group will receive no intervention.
| Study group | Role | What they receive |
|---|---|---|
| Survey by email | Experimental | One arm of investigators will receive the survey to answer by email, reminding the necessity of posting basic results Receives: Other: survey by email |
| Non interventional arm | No intervention | This arm will receive no intervention (no email with the survey) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportions of trials with posted results at 90 days will be compared using a chi-square test to the control group.
Primary endpoint: the proportions of trials with posted results on the registry at 90 days will be compared to the control group using a chi-square test.
Measured: 90 days
Secondary outcomes (1)
The proportions of trials with posted results on the registry at 180 days will be compared to the control group using a chi-square test.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionMay 2013
- Study completionMay 2013
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 Will Focus on no Specific ConditionsStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 379 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Ravaud, MD, PhD, Principal investigator, Hotel-Dieu, Clinical Epidemiology Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01658254
- Sponsor's protocol ID
- PR 738
- Acronym
- REGIST
- Status last verified
- Jun 2012
- First submitted
- 20 Jun 2012
- Last updated
- 30 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Maruani A, Boutron I, Baron G, Ravaud P. Impact of sending email reminders of the legal requirement for posting results on ClinicalTrials.gov: cohort embedded pragmatic randomized controlled trial. BMJ. 2014 Sep 19;349:g5579. doi: 10.1136/bmj.g5579.
PubMed 25239625
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Randomized Controlled Trial Evaluating the Effect of Sending a Reminder to Responsible Parties of Clinical Trials in the Posting of Basic Results Onto ClinicalTrials.Gov
- ClinicalTrials.gov ID
- NCT01658254
- Acronym / sponsor ID
- REGIST / PR 738
- Keywords
- Clinical trials, Basic results, Registry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 379 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 6 Aug 2012 (estimated)
- 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.
The gap between the high number of registered trials and the few ones where results were available (in registries or in journals) has been identified as a major problem distorting the scientific evidence available. As a consequence, the FDAAA (Food and Drug Administration Amendments Act) added on September 27, 2007 a requirements policy regarding publication of summary results on the publicly accessible registry ClinicalTrials.gov. Reporting of summary results is required for "applicable clinical trials" no later than one year after the "primary completion date", i.e. the date of collection of primary outcome data on the last patient to be enrolled. 'Applicable clinical trials', is the term used in the FDAAA to designate trials that may be subject to the registration and reporting requirements.
Not complying with the reporting requirements can result in penalties, such as withholding of National Institute of Health grant or funding and civil monetary penalties of up to $10,000 a day. Despite the possibility of incurring penalties for not complying with the posting requirement, compliance remains globally poor.
In this current study, the primary objective will be to test the hypothesis that sending an email looking as a survey, reminding the necessity of posting results to the trials' responsible parties registered in ClinicalTrials.gov and subject to mandatory reporting but not complying with it, will increase the results posting rate.
Detailed description
According to the recommendation of 2005 by International Committee of Medical Journal Editors (ICMJE), clinical trials must be registered before enrolment of the first patient in a free registry recognized by the World Health Organization (WHO). The goal is to improve transparency of clinical research. The ClinicalTrials.gov trial registry, initiated subsequently to the US Food and Drug Administration Modernization Act (FDAMA) in 1997, is the widest used registry, and contains more than 121 000 studies located in 179 countries (data of March 1, 2012).
The gap between the high number of registered trials and the few ones where results were available (in registries or in journals) has been identified as a major problem distorting the scientific evidence available, and inducing publication bias. As a consequence, the FDAAA (Food and Drug Administration Amendments Act) added on September 27, 2007 a requirements policy regarding publication of summary results on the publicly accessible registry ClinicalTrials.gov. Reporting of summary results is required for "applicable clinical trials" no later than one year after the "primary completion date", i.e. the date of collection of primary outcome data on the last patient to be enrolled. 'Applicable clinical trials', is the term used in the FDAAA to designate trials that may be subject to the registration and reporting requirements. They include interventional controlled studies registered after the enactment of the FDAAA (or ongoing at this date), involving drugs, biologics, or devices (only after FDA-approved for any use), regardless of sponsorship; phases II through IV; located at least in one U.S. site.
The entity or individual responsible for registering and posting basic results is called the 'responsible party'. This term refers to the sponsor of the study or the principal investigator of the study, if so designated by a sponsor, grantee, contractor, or awardee.
In certain circumstances, delayed submission of results information with certification can be allowed. Not complying with the reporting requirements can result in penalties, such as withholding of National Institute of Health grant or funding and civil monetary penalties of up to $10,000 a day. Despite the possibility of incurring penalties for not complying with the posting requirement, compliance remains globally poor.
In this current study, the primary objective will be to test the hypothesis that sending an email asking to answer a survey, reminding the necessity of posting results to the trials' responsible parties registered in ClinicalTrials.gov and subject to mandatory reporting but not complying with it, will increase the results posting rate.
The secondary objective will be to investigate the reasons given by the trials' responsible parties for not posting summary results onto the registry.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Survey by email | Experimental | Other: survey by emailOne arm of investigators will receive the survey to answer by email, reminding the necessity of posting basic results |
| Non interventional arm | No intervention | –This arm will receive no intervention (no email with the survey) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Interventional studies of drugs, biological or devices
- Studies which are closed and either completed or active but not recruiting anymore
- Studies with at least one site in the USA
- Studies registered as phase IV
- Studies with a primary completion date or, if missing, a completion date ranging from October 2008 to January 2011
Key exclusion criteria (8 listed)
- Studies which are still recruiting
- Studies which are either withdrawn or suspended
- Studies which primary completion date is less than one year
- Studies without a given primary completion date or completion date
- Studies involving interventions which are neither drugs or biologics nor devices will be excluded
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 |
|---|---|---|
| survey by emailThe intervention consists in an email to be sent to the sponsor and/or principal investigator of randomly assigned trials. This email will notify them that their trial's primary completion date is over a year old and will ask the reasons why they have not posted results on the registry. Several reasons will be proposed, and investigators or sponsors will be asked to reply by sending back an email or through a website where the same questions will appear. A follow-up email will systematically be sent 7 days after, with similar content (appendix2). The emails will be sent as direct emails, without attached files, with the edit subject "Posting basic results". The controlled group will receive no intervention. | Other | Survey by email |
Primary outcome
The proportions of trials with posted results at 90 days will be compared using a chi-square test to the control group.
Time frame: 90 days
Primary endpoint: the proportions of trials with posted results on the registry at 90 days will be compared to the control group using a chi-square test.
1 secondary outcome
The proportions of trials with posted results on the registry at 180 days will be compared to the control group using a chi-square test.
Time frame: 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2014.
- Derived from this study: PubMed 25239625Maruani A, Boutron I, Baron G, Ravaud P. Impact of sending email reminders of the legal requirement for posting results on ClinicalTrials.gov: cohort embedded pragmatic randomized controlled trial. BMJ. 2014 Sep 19;349:g5579. doi: 10.1136/bmj.g5579.
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.
Philippe Ravaud, MD, PhD principal investigator
Hotel-Dieu, Clinical Epidemiology Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing survey by email in people with The Study Will Focus on no Specific Conditions, 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 6 inclusion and 8 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: finished, as of the sponsor's last update on 30 Sep 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportions of trials with posted results at 90 days will be compared using a chi-square test to the control group. (time frame: 90 days). 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 NCT01658254, 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 30 Sep 2014.