Novo Nordisk Clinical Trials

Topics: Clinical trial, Business ethics, Informed consent Pages: 15 (707 words) Published: June 5, 2015
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 laws
 Strength of intellectual protection

Criteria

Infrastructure and Environment (15%)





Protection of intellectual property
Health-care infrastructure
Country infrastructure
Country risk factors

Ethical issues of offshoring Clinical
Trials
Medical ethics

Scientific ethics

Ethical business

• Voluntary informed consent
• Respect of patients
• Independent review

•The need for rigorous tests prior to launching new
medications

•Balance activities engaged in corporate social
responsibility with the pursuit of profit

Corporate Sustainability at Novo
Nordisk
“Triple Bottom Line”

Novo Nordisk’s Position on Clinical
Trials
■ Clinical trials sponsored by Novo Nordisk will always be conducted according to the Helsinki Declaration and similar ethical guidelines (Nurnberg, Belmont, etc.)

■ Novo Nordisk will apply the same procedures wherever we sponsor clinical trials. This means that all subjects enrolled in Novo Nordisk trials are protected by the same rights, high ethical standards and regulations irrespective of location of the study.

Novo Nordisk’s Position on Clinical
Trials
■ Novo Nordisk will not conduct clinical trials for drug development in countries where we do not intend to market the investigational drug. ■ No trial activity in Novo Nordisk-sponsored trials will start before approval is obtained from external local ethics committees and health

authorities.
■ Products used in Novo Nordisk-sponsored clinical trials will be manufactured and controlled according to international and local regulations and laws. Novo Nordisk will conduct frequent site monitoring to ensure that the study is executed according to the study protocol.

CLASS
DISCUSSION
Ethical Issues in Offshore Clinical Trials

Debate
I.

What are the Main Ethical Challenges of Offshoring
Clinical Trials?

Debate
I.

What are the Main Ethical...
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