Services
Clinical development
Development of data-driven study design

Pre-run of clinical trial design (test of inclusion/exclusion)

Description

A qualification of the assessments in randomised clinical trials by exploring how current standard of care patients respond.  The pre-run can test:-

  • The  inclusion/exclusion  criteria e.g. concomitant medication
  • Duration of the study
  • Improvement of power calculation etc.
Method

Selection of data from all patients on standard of care of the chosen therapeutic area and make a dry run of the clinical study on standard of care.

Primary data sources
EPJ (elektroniske patientjournaler)
Partners
References and publications
More insight
Bookmark:
Save as PDF or print:
Share:
Learn more
Services
‍
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