Services
Post Marketing Approval
Phase IV and Life Cycle management

Phase IV effectiveness studies

Description

To follow and explore the everyday effectiveness of a new medical treatment after launch.

Method

To explore effect and side effect and compare to expected outcomes from randomised clinical trials.

Primary data sources
EPJ (elektroniske patientjournaler)
Partners
References and publications
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Services
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Research and Pre-clinical development
Clinical development
Post Marketing Approval
Identification of unmet needs
Overview of published side/ effects of standard of care/ competitors
Prevalence and patient journey
Identification of unmet needs
Overview of published side/ effects of standard of care/ competitors
Prevalence and patient journey
Development of data-driven study design
Patient identification and selection
Conduct of clinical trial
Test of failed study compared to full Danish population
Pre-run of clinical trial design (test of inclusion/exclusion)
Enrolment of patients based on medical history
Enrolment of patients based on laboratory data
Feasibility study
Artificial standard of care arm
Continued (24/7) assessment of real-world side-effect
Randomised clinical studies
Continued (24/7) assessment of real-world effectiveness
Development of data-driven study design
Patient identification and selection
Conduct of clinical trial
Test of failed study compared to full Danish population
Pre-run of clinical trial design (test of inclusion/exclusion)
Enrolment of patients based on medical history
Enrolment of patients based on laboratory data
Feasibility study
Artificial standard of care arm
Continued (24/7) assessment of real-world side-effect
Randomised clinical studies
Continued (24/7) assessment of real-world effectiveness
Phase IV and Life Cycle management
Health economic assessments
Patient centric information of likelihood of effect and side-effect
Assessment of adherence
Phase IV effectiveness studies
Cost of municipality care
Overall cost effectiveness
Cost of illness & budget impact
Performance based innovative pricing
Phase IV and Life Cycle management
Health economic assessments
Patient centric information of likelihood of effect and side-effect
Assessment of adherence
Phase IV effectiveness studies
Cost of municipality care
Overall cost effectiveness
Cost of illness & budget impact
Performance based innovative pricing