Industry support of investigator sponsored trials: do's and dont's.

1. Applied Clinical Services BV
Annet Muetstege| Investigator Initiated Trials
24 November 2013
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2. Physician Initiated Studies?
24 November 2013
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3. Physician Initiated Studies
◄PRO’s
• Physician/ clinician interest
• Typically reflects daily
practice
• Relatively industry
independent
◄CON’s
• Data may not apply to other
hospitals/ countries
■ Different expertise
■ Different reimbursement mechanism
• Data Quality might be less
than industry-sponsored
studies
■ Less on site monitoring, if any at all
• Require less resources than
industry-sponsored studies
• Flexible
24 November 2013
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4. Did you know that …..
◄ Sponsor - in relation to a study - means, the person or organization
that takes on ultimate responsibility for the initiation and management
(or arranging the initiation and management) of, and the financing (or
arranging the financing) for, that study?
◄ Sponsorship includes liability?
◄ A physician sponsored study is any clinical study, including registries,
where project responsibility is with the initiating physician or
institution even if industry is funding (part of) the study?
◄ A registry is any systematic data collection of patients with certain
shared characteristics (e.g., particular disease, risk factor, product)
where subjects receive standard hospital treatment?
◄ A registry can be either physician or industry responsibility?
24 November 2013
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5. Physician Studies or Registries
When industry provides support:
◄ Do
• Provide the physician with
product information
including safety and
indication for use
• Involve a clinical research
expert for scientific and
ethical advice on study
conduct
• Ensure that clinical
documents represent
sponsorship the correct way
• Have an agreement in place
specifying roles and
responsibilities
24 November 2013
◄ Don’t
• Deploy sponsor activities
outside what is agreed to with
the PI in the agreement
■
■
■
■
Data-management/ analyses
Monitoring
Protocol writing
….
• Provide additional funding
outside what is agreed to with
the PI in the agreement
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6. Questions?
Applied Clinical Services BV
I
E
T
C
24 November 2013
www.appliedclinicalservices.com
info@appliedclinicalservices.com
+31 26 8485 281
+31 6 5330 2680
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