Regulation of clinical trials
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Regulation of Clinical Trials . Robert Silbergleit, MD Department of Emergency Medicine NETT Clinical Coordinating Center. Good Clinical Practice (GCP). FDA 21 CFR 50-56. + Common Rule 45 CFR 46. 17. IRB. PI. Sponsor. Funder/IC. DSMB.

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Regulation of Clinical Trials

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Regulation of clinical trials

Regulation of Clinical Trials

Robert Silbergleit, MDDepartment of Emergency MedicineNETT Clinical Coordinating Center


Regulation of clinical trials

Good Clinical Practice (GCP)

FDA

21 CFR 50-56

+

Common Rule

45 CFR 46

17

IRB

PI

Sponsor

Funder/IC

DSMB


Regulation of clinical trials

Longest history of regulationof clinical trials

Helsinki principles +/- (1964)

Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications

Sponsors - initiate and monitor

Investigators - plan and perform

IRBs - review and approve

All drugs and devices in clinical research unless exempt

FDA

21 CFR 50-56


Regulation of clinical trials

Belmont Principles (1979)

Beneficence

Justice

Respect for persons

IRB + informed consent requirements

Agriculture, Energy, Commerce, HUD, Justice, Defense, Education, VA, Transportation, Homeland, NSF, NASA, EPA, AID, SSA, CIA, CPSC

Federally funded research, or research conducted by an institution with an FWA

+

Common Rule

45 CFR 46

17


Regulation of clinical trials

Previously OPRR within NIH

Compliance oversight

Mostly institutional

Policy and assurances

Federal Wide Assurance (FWA)

Registration of IRB’s

Education and development

Provides guidance

Educational programs

SACHRP

International

+

Common Rule

45 CFR 46

17

Federal Wide Assurance (FWA)

is a commitment by an institution to the HHS to comply with the common rule.


Regulation of clinical trials

International Conference on Harmonization

Helsinki Principles (13 actually)

Designing, conducting, recording, reporting trials

E6: GCP Consolidated Guideline 1996

Reflect FDA regulations and/or guidance

Are conditions for FDA accepting non-US trials

Distinct from WHO guidelines for GCP

Good Clinical Practice (GCP)


Regulation of clinical trials

NIH provides

Peer review - content expertise

Methodology

Human subjects protection

Funding

Ongoing review

CSR

PI

Funder/IC

DSMB


Regulation of clinical trials

Institutional or independent

role of central IRB’s

Implement/interpret the reg’s

Composition

Relatively little content expertise

Consider local context

Communicate with investigators

Review and approve applications

Review ongoing safety and conduct

Unfunded mandates

Accreditation controversy

IRB

PI

Sponsor

Funder/IC

DSMB


Regulation of clinical trials

Work for Sponsor or the Funder

Advice on safety/performance during the ongoing trial

Composition variable

Mandate is variable

IRB

PI

Sponsor

Funder/IC

DSMB


Regulation of clinical trials

Good Clinical Practice (GCP)

FDA

21 CFR 50-56

IRB

PI

Sponsor

DSMB


Regulation of clinical trials

+

Common Rule

45 CFR 46

17

IRB

PI

Funder/IC

DSMB


Regulation of clinical trials

Good Clinical Practice (GCP)

FDA

21 CFR 50-56

+

Common Rule

45 CFR 46

17

IRB

PI

Sponsor

Funder/IC

DSMB


Regulation of clinical trials

FDA

21 CFR 50-56

IRB

PI

Sponsor

Funder/IC

DSMB


Regulation of clinical trials

Good Clinical Practice (GCP)

FDA

21 CFR 50-56

+

Common Rule

45 CFR 46

17

IRB

PI

Sponsor

Funder/IC

DSMB


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