Transcript What is involved?

Investigational New Drug Application
(IND)
What is involved? What are your responsibilities?
May 2013: Research Institute, Clinical Research Administration
Topics
• 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
KUMC Research Institute, 2013
Definition of IND
• 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
KUMC Research Institute, 2013
What are roles and responsibilities
• Sponsor: a person who takes responsibility for and initiates a
clinical investigation. The sponsor may be a/an:
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Individual
Pharmaceutical Company
Governmental Agency
Academic Institution
Private or Other Organization
• A sponsor does not actually conduct the investigation
KUMC Research Institute, 2013
What are roles and responsibilities
• 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
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What are roles and responsibilities
• Investigator: an individual who actually conducts a clinical
investigation (i.e. under whose immediate direction the drug is
administered and dispensed to a subject).
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What are roles and responsibilities
• 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)
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What are roles and responsibilities
• 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.
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When an IND is needed
• 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.
KUMC Research Institute, 2013
When an IND not needed
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 States
2. 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 product
3. The investigation is not intended to support a significant change in advertising
to an existing lawfully marketed prescription drug product
4. 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
KUMC Research Institute, 2013
What is involved in IND submission
• 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
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
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What is a 1571?
• 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”.
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What is a 1572?
• Called the “Statement of
Investigator”
• Lists Commitments of the
Investigator
• Provides Required
Information to the FDA
Criteria 1572 Fulfills for IND:
• Location of PI, Study, Labs
• Name of Responsible IRB
• Names of Sub-Investigators
Found at:
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM074728.pdf
KUMC Research Institute, 2013
What is involved in IND submission
• 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)
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What is involved in IND submission
• 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.
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What If I Need an IND?
• 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
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Investigator
CRA
• Protocol
• Expertise
• Design
• FDA
Preparation
• IRB
Preparation
What is involved after initial IND
submission?
• 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)
KUMC Research Institute, 2013