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

May 21, 2008
August 11, 2010
May 2008
June 2010   (final data collection date for primary outcome measure)
Proportion of patients' file without severe error. [ Time Frame: at end of follow-up ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00780091 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Optimisation of Monitoring for Clinical Research Studies
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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

All type of patients enrolled in the eligible studies

Healthy
  • Other: classical monitoring strategy
    intensive on-site monitoring, consistently with the pharmaceutical industry practices
  • Other: optimized monitoring strategy
    optimized on-site monitoring, depending on patient's risk
  • 1
    classical monitoring strategy
    Intervention: Other: classical monitoring strategy
  • 2
    optimized monitoring strategy
    Intervention: Other: optimized monitoring strategy
Liénard 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1800
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00780091
CHUBX 2005/04
Yes
Jean-Pierre LEROY / Clinical Research and Innovation Director, University hospital, Bordeaux
University Hospital, Bordeaux
Not Provided
Study Director: Geneviève CHENE, MD, PhD University Hospital, Bordeaux
University Hospital, Bordeaux
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP