Optimisation of Monitoring for Clinical Research Studies (OPTIMON)

University Hospital of Bordeaux

Status

Completed

Conditions

Healthy

Treatments

Other: optimized monitoring strategy

Other: classical monitoring strategy

Study type

Observational

Funder types

Other

Identifiers

NCT00780091

CHUBX 2005/04

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,800 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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