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Optimisation of Monitoring for Clinical Research Studies (OPTIMON)

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00780091
First received: May 21, 2008
Last updated: August 11, 2010
Last verified: August 2010
History of Changes
  Purpose

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 Intervention
Healthy
 Other: classical monitoring strategy
Other: optimized monitoring strategy

Study Type: Observational
Study Design: 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

Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Proportion of patients' file without severe error. [ Time Frame: at end of follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compounds of the main outcome, other errors, delay to get the results, costs [ Time Frame: at end of follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 1800
Study Start Date: May 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
classical monitoring strategy
 Other: classical monitoring strategy
intensive on-site monitoring, consistently with the pharmaceutical industry practices
2
optimized monitoring strategy
 Other: optimized monitoring strategy
optimized on-site monitoring, depending on patient's risk

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

All type of patients enrolled in the eligible studies

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00780091

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

Publications:

Responsible Party: Jean-Pierre LEROY / Clinical Research and Innovation Director, University hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00780091     History of Changes
Other Study ID Numbers: CHUBX 2005/04
Study First Received: May 21, 2008
Last Updated: August 11, 2010
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on June 18, 2013