Novo Nordisk Clinical Trials
New Medication :Clinical Trials
Phase
I
II
III
IV
Requirements
Testing an experimental drug or treatment in a, small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects
The experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety
The experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely
Post marketing studies obtain additional information including the drug's risks, benefits, and optimal use
Higher percentage of offshoring
Percentage and Number of Studies in US and Offshore Locations – by
Phase
Observations
• Phase 3 studies are more likely to have locations outside the US:
– Patient populations required are large
– Investigator grants and patient compensation is a large part of trial cost, making certain offshore locations attractive
• Phase 1 studies have comparatively fewer offshore locations: – Ethical considerations as this phase determines safety of the trial drug
– Focus on healthy volunteers vs. specific patient profile • Phase 4 studies are increasingly including locations/ data from patients in countries outside the US once the drug is on the market
Studies with location in US only
Studies with location outside US
Attractiveness of offshoring
Index Criteria and Weighting
Patient Pool (30%)
Size and availability of suitable patient pool Regulatory Conditions (20%)
Cost Efficiency (20%)
Cost efficiency of labor
Cost efficiency of facilities and travel
Relevant Expertise (15%)
Number of clinical research organizations
Number of clinical trials
Size and availability of labor force with relevant skills
Food and Drug Administration visibility
Country’s regulatory
Phase
I
II
III
IV
Requirements
Testing an experimental drug or treatment in a, small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects
The experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety
The experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely
Post marketing studies obtain additional information including the drug's risks, benefits, and optimal use
Higher percentage of offshoring
Percentage and Number of Studies in US and Offshore Locations – by
Phase
Observations
• Phase 3 studies are more likely to have locations outside the US:
– Patient populations required are large
– Investigator grants and patient compensation is a large part of trial cost, making certain offshore locations attractive
• Phase 1 studies have comparatively fewer offshore locations: – Ethical considerations as this phase determines safety of the trial drug
– Focus on healthy volunteers vs. specific patient profile • Phase 4 studies are increasingly including locations/ data from patients in countries outside the US once the drug is on the market
Studies with location in US only
Studies with location outside US
Attractiveness of offshoring
Index Criteria and Weighting
Patient Pool (30%)
Size and availability of suitable patient pool Regulatory Conditions (20%)
Cost Efficiency (20%)
Cost efficiency of labor
Cost efficiency of facilities and travel
Relevant Expertise (15%)
Number of clinical research organizations
Number of clinical trials
Size and availability of labor force with relevant skills
Food and Drug Administration visibility
Country’s regulatory