Optimisation of Monitoring for Clinical Research Studies

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Efficacy and Cost of Two Monitoring Strategies for Public Clinical Research - OPTIMON: Optimisation of Monitoring for Clinical Research Studies

Conditions
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Healthy

Intervention / Treatment
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* Other: classical monitoring strategy
* Other: optimized monitoring strategy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: N/A
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>classical monitoring strategy | Other: classical monitoring strategy<br>* intensive on-site monitoring, consistently with the pharmaceutical industry practices<br>|
| 2<br>optimized monitoring strategy | Other: optimized monitoring strategy<br>* optimized on-site monitoring, depending on patient's risk<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients' file without severe error. |  | at end of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compounds of the main outcome, other errors, delay to get the results, costs |  | at end of follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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optimization, risk scale, non inferiority, cluster randomization, monitoring strategies