investigational new drug application (ind)

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What is involved? What are your responsibilities? May 2013: Research Institute, Clinical Research Administration Investigational New Drug Application (IND)

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Investigational New Drug Application (IND). What is involved ? What are your r esponsibilities? May 2013: Research Institute, Clinical Research Administration. Topics. Definition of IND R oles and Responsibilities of: Sponsor Investigator Sponsor-Investigator When an IND needed - PowerPoint PPT Presentation

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Page 1: Investigational New Drug Application (IND)

What is involved? What are your responsibilities?

May 2013: Research Institute, Clinical Research Administration

Investigational New Drug Application (IND)

Page 2: Investigational New Drug Application (IND)

KUMC Research Institute, 2013

• Definition of IND• Roles and Responsibilities of:• Sponsor• Investigator• Sponsor-Investigator

• When an IND needed• When an IND not needed• What is involved with an IND submission• Management of Active IND

Topics

Page 3: Investigational New Drug Application (IND)

KUMC Research Institute, 2013

• Provisions of the IND Regulation – 21 CFR 312• “An investigational new drug for which an IND is in effect in

accordance with this part is exempt from premarketing approval requirements…and may be shipped lawfully for purpose of conducting investigation of that drug”• IND is regulatory mechanism for new drug development

Definition of IND

Page 4: Investigational New Drug Application (IND)

KUMC Research Institute, 2013

• Sponsor: a person who takes responsibility for and initiates a clinical investigation. The sponsor may be a/an:• Individual• Pharmaceutical Company• Governmental Agency• Academic Institution• Private or Other Organization

• A sponsor does not actually conduct the investigation

What are roles and responsibilities

Page 5: Investigational New Drug Application (IND)

KUMC Research Institute, 2013

• Select Sponsor Requirements (21 CFR 312.50):• Select qualified investigators by education and experience• Provide investigators with all information needed to conduct the

investigation properly• Monitor the study• Ensure study is conducted according to protocol• Inform FDA and investigators of significant new adverse effects or risks

with respect to the drug

What are roles and responsibilities

Page 6: Investigational New Drug Application (IND)

KUMC Research Institute, 2013

• Investigator: an individual who actually conducts a clinical investigation (i.e. under whose immediate direction the drug is administered and dispensed to a subject).

What are roles and responsibilities

Page 7: Investigational New Drug Application (IND)

KUMC Research Institute, 2013

• Select Investigator Requirements (21 CFR 312.60):• Ensure the investigation is conducted according to:

• The signed investigator statement (1572)• The investigational plan• Applicable regulations

• Protecting rights, safety and welfare of subject’s under investigator’s care• Control of drugs• Obtain informed consent (unless there is a waiver of consent, see 21

CFR 50.23 or 50.24)

What are roles and responsibilities

Page 8: Investigational New Drug Application (IND)

KUMC Research Institute, 2013

• Sponsor-Investigator: an individual who both initiates and conducts an investigation, and under whose immediate direction the drug is administered or dispensed.• Always an individual• Requirements of Sponsor-Investigator include both those applicable to

an investigator and a sponsor• This role applicable to many KUMC IND’s. For more information on

additional requirements of role, contact the HSC and Research Institute.

What are roles and responsibilities

Page 9: Investigational New Drug Application (IND)

KUMC Research Institute, 2013

• A sponsor shall submit an IND to FDA if the sponsor intends to conduct a clinical investigation with an investigational new drug that is subject to 312.2(a)• Submit an IND if any exempt criteria are not met• If you are uncertain if an IND is required, please contact the Research

Institute. We will help you with the determination or submit a request to the FDA for a determination.

When an IND is needed

Page 10: Investigational New Drug Application (IND)

KUMC Research Institute, 2013

For a study to be exempt from an IND, it must meet ALL six criteria:1. The investigational drug is lawfully marketed in the United States2. The investigation is not intended to be reported to the FDA as a well-controlled study in

support of a new indication for use of the drug product3. The investigation is not intended to support a significant change in advertising to an existing

lawfully marketed prescription drug product4. The investigation does not involve a route or administration or dosage level or use in a

patient population or other factor that significantly increases the risks (or decreases the acceptability of the risks) associated with the use of the drug product

5. The investigation will be conducted in compliance with the requirements for institutional review set forth in FDA regulations 21 CFR 56, and requirements for informed consent as set forth in FDA regulations 21 CFR 50

6. The investigation will be conducted in compliance with FDA regulations 21 CFR 312.7: Promotion and charging for investigational drugs

When an IND not needed

Page 11: Investigational New Drug Application (IND)

KUMC Research Institute, 2013

• Content requirements for an IND submission are found in 21 CFR 312.23• Essential forms for a submission:• 1571: must accompany every submission to the FDA for the IND• 1572: Statement of Investigator• 3674: related to clinicaltrials.gov posting

What is involved in IND submission

Page 12: Investigational New Drug Application (IND)

KUMC Research Institute, 2013

What is a 1571?

• Required Form for EVERY IND Submission• Details what is included in submission• Identifies Study Information used to Classify the study

• Found at:http://www.fda.gov/downloads/aboutfda/reportsmanualsforms/forms/ucm083533.pdf

Page 13: Investigational New Drug Application (IND)

KUMC Research Institute, 2013

• Important: by signing you agree not to begin any clinical investigations:• “…until 30 days after FDA’s receipt of the IND unless I receive earlier

notification by FDA that the studies may begin…”And;• “…covered by the IND if those studies are placed on clinical hold or

financial hold”

• If you do not hear any response from the FDA for 30 days after the date they receive the submission, the IND is considered “in effect”.

What is a 1571?

Page 14: Investigational New Drug Application (IND)

KUMC Research Institute, 2013

Criteria 1572 Fulfills for IND:• Location of PI, Study, Labs• Name of Responsible IRB• Names of Sub-Investigators

What is a 1572?

• Called the “Statement of Investigator”• Lists Commitments of the

Investigator• Provides Required

Information to the FDA

Found at:http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM074728.pdf

Page 15: Investigational New Drug Application (IND)

KUMC Research Institute, 2013

• Essential documents for a submission:• Cover letter/Introductory Statement /General Investigational Plan (2-3

pages)• Investigator’s Brochure (if available from manufacturer; not required for

single center investigator initiated trial submissions)• Protocol• Draft Informed Consent Form• Cross Reference Letter (provided by manufacturer which gives

submission right to reference all previous data related to drug submitted to the FDA – chemistry, pharmacology and toxicology, previous human experience)

What is involved in IND submission

Page 16: Investigational New Drug Application (IND)

KUMC Research Institute, 2013

• Depending on the study, there may be additional requirements for the IND submission. • The CRA has experience compiling, submitting and managing

IND’s for KUMC Investigators. Your Clinical Trial Project Manager in the CRA will assist you through the entire process.

What is involved in IND submission

Page 17: Investigational New Drug Application (IND)

KUMC Research Institute, 2013

Investigator• Protocol• Expertise• Design

CRA• FDA

Preparation• IRB

Preparation

• Investigator and CRA a Team for IND Submission• Investigator brings expertise

and protocol• CRA brings FDA and IRB

submission and approval know how• Together, research moves

forward

What If I Need an IND?

Page 18: Investigational New Drug Application (IND)

KUMC Research Institute, 2013

• Continuing management of the IND is essential. Submissions to the FDA to keep them appraised of study activity includes:• Annual Reports (Sponsor; 312.33): due within 60 days of IND

anniversary date (date the IND went into effect)• Unanticipated Problem Reports (Sponsor): to the FDA and any sub-sites• Revised Protocol (Sponsor): changes in risk/benefit of trial, change that

impacts subject safety• Changes in the study team, study sites (Investigator)

What is involved after initial IND submission?