Multicenter Trails
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MULTICENTER TRAILS Dattuprasad.S.Kalashetty Guided by Dr.praveena
Definition
A Multicenter trail utilizes one protocol at more than one site ,although the protocol is usually implemented and conducted in a somewhat different manner & style at each site
SITE
Multi speciality hospital with adequate patient & laboratory facilities
GOLDEN RULES Protocol designed be kept simple & same at all center Carefull planning of the trail be mandatory Communication problems be minimized
DESIGNING A MULTICENTER TRAIL
Choice of comparator The placebo controlled trail Patient population Concurent diseases Concomitant medication Clinical measurement
DATA MANAGEMENT
Visual check (if there is a significant amount of textual data) STATISTICAL ISSUES Should data from each site be able to stand alone ? Many multicenter trail be divided into multiple single-site clinical trails ?
SPONSOR For multicenter trails , sponsor should ensure that All investigation conduct the trail in strict compliance with the protocol The CRFs are designed to capture the required data at all multicenter trail sites The responsibilities of coordinating investigatore’s and the other participating investigators are documented prior to the start of the trail All investigators are given instructions on following the protocol
Contd…,
Communications between investigators is facilitated ETHICS COMMITTEE APPROVAL Approval from the LREC
Advantages
More rapid patient recruitment More complex protocols may be able to be conducted because of additional resource utilized for certain large trails Less opportunity for one person’s biases to influence the design or conducted at a high standard Greater likelihood for a heterogeneous patient population to be enrolled
Disadvantages
Administrative management details are more complex Costs are usually greater for the clinical trail than if the same total number of patient were studied at a single site Statistical data analyses would be strong from a single site Some ethics committees/IRBs may insist on change to the protocol that create major delays or are unacceptable to the sponsor or other ethics committees/IRBs Individual investigators in a large multicenter trails receive little recognition through the publications of results
EXAMPLE
A phase I multicenter clinical trail to evalvate the safety and immunogenenicity of ImmunoAg Recombinant HIV gp 160 in Asymptomatic HIV seropositive Individuals Study design : Trcatment ,placebo control, safety study Expected total enrollment :55 healthy HIV+ve volunteers
Definition
A Multicenter trail utilizes one protocol at more than one site ,although the protocol is usually implemented and conducted in a somewhat different manner & style at each site
SITE
Multi speciality hospital with adequate patient & laboratory facilities
GOLDEN RULES Protocol designed be kept simple & same at all center Carefull planning of the trail be mandatory Communication problems be minimized
DESIGNING A MULTICENTER TRAIL
Choice of comparator The placebo controlled trail Patient population Concurent diseases Concomitant medication Clinical measurement
DATA MANAGEMENT
Visual check (if there is a significant amount of textual data) STATISTICAL ISSUES Should data from each site be able to stand alone ? Many multicenter trail be divided into multiple single-site clinical trails ?
SPONSOR For multicenter trails , sponsor should ensure that All investigation conduct the trail in strict compliance with the protocol The CRFs are designed to capture the required data at all multicenter trail sites The responsibilities of coordinating investigatore’s and the other participating investigators are documented prior to the start of the trail All investigators are given instructions on following the protocol
Contd…,
Communications between investigators is facilitated ETHICS COMMITTEE APPROVAL Approval from the LREC
Advantages
More rapid patient recruitment More complex protocols may be able to be conducted because of additional resource utilized for certain large trails Less opportunity for one person’s biases to influence the design or conducted at a high standard Greater likelihood for a heterogeneous patient population to be enrolled
Disadvantages
Administrative management details are more complex Costs are usually greater for the clinical trail than if the same total number of patient were studied at a single site Statistical data analyses would be strong from a single site Some ethics committees/IRBs may insist on change to the protocol that create major delays or are unacceptable to the sponsor or other ethics committees/IRBs Individual investigators in a large multicenter trails receive little recognition through the publications of results
EXAMPLE
A phase I multicenter clinical trail to evalvate the safety and immunogenenicity of ImmunoAg Recombinant HIV gp 160 in Asymptomatic HIV seropositive Individuals Study design : Trcatment ,placebo control, safety study Expected total enrollment :55 healthy HIV+ve volunteers
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