RDLA February 26 2014 Michael J Werner Overarching Principles The situation usually arises because someone is very sick and wants access to an unapproved product outside of a clinical trial ID: 461149
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Slide1
Ethical Issues Related to Compassionate Use
RDLA,
February 26, 2014
Michael J. WernerSlide2
Overarching Principles
The situation usually arises because someone is very sick and wants access to an unapproved product outside of a
clinical trial
FDA has policies designed to provide access to such patients
Companies are confronted with an ethical dilemma
2Slide3
Ethical Points to Consider (BIO)
Companies have an ethical responsibility to develop and market products as fast as possible
Patient autonomy does not supercedeAutonomy means cannot be forced to receive treatments/informed consent – not an absolute right to an unapproved product
Company ethical priority is not jeopardizing clinical program that will help many patients
Providing a product through compassionate use could put clinical program at risk
3Slide4
Points to Consider (
con’t)
Early access could hurt the integrity of clinical trial process
Diminish incentive for patients to participateCan a patient in this situation provide truly informed consent?
By definition, there is likely insufficient safety
data
Can the company be sure such data exists?
How can a company ensure equity in distribution of a product outside a clinical trial?
Which patients get the product (best lawyer? Most Twitter followers
?)
Can the company develop inclusion/exclusion criteria
4Slide5
Other Issues for Companies
Life threatening condition?
Other treatment options (including clinical trials)?Are they confident product has sufficiently demonstrated safety?Is there any efficacy data for the product?
Legal liability?Opinion of patient’s treating physician?
5Slide6
Concluding Points
Companies/sponsors have an ethical obligation to get products to the market as soon as possible
Actions that put a clinical program at risk are counter to that obligation
Other options to provide products to patients are potentially fraught with other ethical challenges
There could be situations where patients get access to unapproved products outside of trials
Many companies try to balance these ethical issues and develop compassionate use policies
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