HealthyOPTIMONNCT00780091
Optimisation of Monitoring for Clinical Research Studies
An observational study of Healthy, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
OPTIMON will compare the efficacy and the cost of two monitoring strategies: one based on the classic standards of quality assurance, and the other one being a priori "optimized" on the main scientific and regulatory principles. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- classical monitoring strategy and optimized monitoring strategy
- How many people
- 1,800 participants
- Where
- 1 siteFrance
- Study dates
- May 2008to Jun 2010
- 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 type of patients enrolled in the eligible studies
Who may be able to join
- Clinical Research Studies: risk level A, B, or C in the Optimon risk-assessment scale, with or without a sponsor and the advice of an ethical committee, starting in 2008 and ending before the end of 2010, with a foreseen accrual of 20 patients or more, multicentric with at least 4 clinical sites, with a paper or electronic CRF, with the participating agreement of the coordinating investigator and the sponsor.
- Clinical sites: Sites with a foreseen accrual of 5 patients at least, with the participating agreement of the principal investigator.
- Clinical Research Units: with the label of an institution, with at least 2 years of experience in multicentric studies, with SOPs finalized before 2008, willing to participate in Optimon.
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
France1 site
Unité de Soutien Méthodologique à la Recherche Clinique et Epidémiologique du CHU de Bordeaux
Bordeaux, 33076
About this study
Official title: Evaluation of Efficacy and Cost of Two Monitoring Strategies for Public Clinical Research - OPTIMON: Optimisation of Monitoring for Clinical Research Studies
OPTIMON will compare the efficacy and the cost of two monitoring strategies: one based on the classic standards of quality assurance, and the other one being a priori "optimized" on the main scientific and regulatory principles.
Read the detailed description
There is no validated standard of monitoring strategy for clinical research studies. Optimon will compare two monitoring strategies - a classical strategy based on the practices of the pharmaceutical industry, and an optimized strategy based on patient's risk level - on their ability to produce exact data, focusing on the main quality criteria: regulatory requirements and scientific validity of results. Optimon is a non inferiority randomized trial.
- Conditions
- Healthy
- Being tested
- classical monitoring strategy, optimized monitoring strategy
- Keywords
- optimization, risk scale, non inferiority, cluster randomization, monitoring strategies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
classical monitoring strategyOther
intensive on-site monitoring, consistently with the pharmaceutical industry practices
optimized monitoring strategyOther
optimized on-site monitoring, depending on patient's risk
| Study group | Role | What they receive |
|---|---|---|
| 1 | classical monitoring strategy Receives: Other: classical monitoring strategy | |
| 2 | optimized monitoring strategy Receives: Other: optimized monitoring strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients' file without severe error.
Measured: at end of follow-up
Secondary outcomes (1)
Compounds of the main outcome, other errors, delay to get the results, costs
Measured: at end of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2008 (estimated)
- Study startMay 2008
- Primary completionJun 2010
- Study completionJun 2010
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 HealthyStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Investigators
- Geneviève CHENE, MD, PhD, Study director, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00780091
- Sponsor's protocol ID
- CHUBX 2005/04
- Acronym
- OPTIMON
- Status last verified
- Aug 2010
- First submitted
- 21 May 2008
- Last updated
- 12 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lienard JL, Quinaux E, Fabre-Guillevin E, Piedbois P, Jouhaud A, Decoster G, Buyse M; European Association for Research in Oncology. Impact of on-site initiation visits on patient recruitment and data quality in a randomized trial of adjuvant chemotherapy for breast cancer. Clin Trials. 2006;3(5):486-92. doi: 10.1177/1740774506070807.
PubMed 17060222
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy and Cost of Two Monitoring Strategies for Public Clinical Research - OPTIMON: Optimisation of Monitoring for Clinical Research Studies
- ClinicalTrials.gov ID
- NCT00780091
- Acronym / sponsor ID
- OPTIMON / CHUBX 2005/04
- Conditions
- Healthy
- Keywords
- optimization, risk scale, non inferiority, cluster randomization, monitoring strategies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 27 Oct 2008 (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.
OPTIMON will compare the efficacy and the cost of two monitoring strategies: one based on the classic standards of quality assurance, and the other one being a priori "optimized" on the main scientific and regulatory principles.
Detailed description
There is no validated standard of monitoring strategy for clinical research studies. Optimon will compare two monitoring strategies - a classical strategy based on the practices of the pharmaceutical industry, and an optimized strategy based on patient's risk level - on their ability to produce exact data, focusing on the main quality criteria: regulatory requirements and scientific validity of results. Optimon is a non inferiority randomized trial.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: classical monitoring strategyclassical monitoring strategy |
| 2 | – | Other: optimized monitoring strategyoptimized monitoring strategy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All type of patients enrolled in the eligible studies
Key inclusion criteria (3 listed)
- Clinical Research Studies: risk level A, B, or C in the Optimon risk-assessment scale, with or without a sponsor and the advice of an ethical committee, starting in 2008 and ending before the end of 2010, with a foreseen accrual of 20 patients or more, multicentric with at least 4 clinical sites, with a paper or electronic CRF, with the participating agreement of the coordinating investigator and the sponsor.
- Clinical sites: Sites with a foreseen accrual of 5 patients at least, with the participating agreement of the principal investigator.
- Clinical Research Units: with the label of an institution, with at least 2 years of experience in multicentric studies, with SOPs finalized before 2008, willing to participate in Optimon.
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| classical monitoring strategyintensive on-site monitoring, consistently with the pharmaceutical industry practices | Other | 1 |
| optimized monitoring strategyoptimized on-site monitoring, depending on patient's risk | Other | 2 |
Primary outcome
Proportion of patients' file without severe error.
Time frame: at end of follow-up
1 secondary outcome
Compounds of the main outcome, other errors, delay to get the results, costs
Time frame: at end of follow-up
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 12 Aug 2010.
- Background: PubMed 17060222Lienard JL, Quinaux E, Fabre-Guillevin E, Piedbois P, Jouhaud A, Decoster G, Buyse M; European Association for Research in Oncology. Impact of on-site initiation visits on patient recruitment and data quality in a randomized trial of adjuvant chemotherapy for breast cancer. Clin Trials. 2006;3(5):486-92. doi: 10.1177/1740774506070807.
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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.
Geneviève CHENE, MD, PhD study director
University Hospital, Bordeaux
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 Healthy, run by University Hospital, Bordeaux 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 3 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: finished, as of the sponsor's last update on 12 Aug 2010. 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?
Proportion of patients' file without severe error. (time frame: at end of follow-up). 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 NCT00780091, 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 12 Aug 2010.