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Applied Clinical Services BV

Annet Muetstege| Investigator Initiated Trials

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Physician Initiated Studies?

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Physician Initiated Studies

◄PRO’s• Physician/ clinician interest

• Typically reflects daily practice

• Relatively industry independent

• Require less resources than industry-sponsored studies

• Flexible

◄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

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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 orinstitution 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?

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Physician Studies or RegistriesWhen 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

◄ 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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Questions?

Applied Clinical Services BVI www.appliedclinicalservices.comE info@appliedclinicalservices.comT +31 26 8485 281C +31 6 5330 2680