Optimisation of Monitoring for Clinical Research Studies (OPTIMON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00780091
Recruitment Status : Completed
First Posted : October 27, 2008
Last Update Posted : August 12, 2010
Information provided by:
University Hospital, Bordeaux

Brief 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.

Condition or disease Intervention/treatment
Healthy Other: classical monitoring strategy Other: optimized monitoring strategy

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 Type : Observational
Estimated Enrollment : 1800 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Evaluation of Efficacy and Cost of Two Monitoring Strategies for Public Clinical Research - OPTIMON: Optimisation of Monitoring for Clinical Research Studies
Study Start Date : May 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Group/Cohort Intervention/treatment
classical monitoring strategy
Other: classical monitoring strategy
intensive on-site monitoring, consistently with the pharmaceutical industry practices

optimized monitoring strategy
Other: optimized monitoring strategy
optimized on-site monitoring, depending on patient's risk

Primary Outcome Measures :
  1. Proportion of patients' file without severe error. [ Time Frame: at end of follow-up ]

Secondary Outcome Measures :
  1. Compounds of the main outcome, other errors, delay to get the results, costs [ Time Frame: at end of follow-up ]

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All type of patients enrolled in the eligible studies

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:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00780091

Unité de Soutien Méthodologique à la Recherche Clinique et Epidémiologique du CHU de Bordeaux
Bordeaux, France, 33076
Sponsors and Collaborators
University Hospital, Bordeaux
Study Director: Geneviève CHENE, MD, PhD University Hospital, Bordeaux

Responsible Party: Jean-Pierre LEROY / Clinical Research and Innovation Director, University hospital, Bordeaux Identifier: NCT00780091     History of Changes
Other Study ID Numbers: CHUBX 2005/04
First Posted: October 27, 2008    Key Record Dates
Last Update Posted: August 12, 2010
Last Verified: August 2010

Keywords provided by University Hospital, Bordeaux:
risk scale
non inferiority
cluster randomization
monitoring strategies