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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00780091

Acronym

OPTIMON

Enrollment

1800

Registered

2008-10-27

Start date

2008-05-31

Completion date

2010-06-30

Last updated

2010-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

optimization, risk scale, non inferiority, cluster randomization, monitoring strategies

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.

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.

Interventions

OTHERclassical monitoring strategy

intensive on-site monitoring, consistently with the pharmaceutical industry practices

OTHERoptimized monitoring strategy

optimized on-site monitoring, depending on patient's risk

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Proportion of patients' file without severe error.	at end of follow-up

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026