The IND and Clinical Trial Management - PowerPoint Presentation

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The IND and Clinical Trial Management

Frances Richmond

Director International Center for Clinical TrialsSlide2

And you are…

The principal investigator of a company-sponsored trial?

The principal investigator of an investigator-sponsored trial?

A clinical coordinator for a study?

Each has its responsibilitiesSlide3

Kefauver-Harris amendments required investigational new drug application and oversight for certain types of drug trialsSlide4

FDA has oversight

if….

You study a

NEW

drug or biologic in the

US

You want to market a

new indication

or

different route of administration

EVEN

THOUGH THE PRODUCT IS ALREADY APPROVEDSlide5

FDA has oversight whether….

You are the investigator and a company is the sponsor

You are the sponsor-investigator

Probably monitored

Probably unmonitoredSlide6

If you are an investigator-sponsor…

You must submit an investigational device exemption

You must sign a 1571 form that obligates you to the responsibilities of monitoring and reporting to FDA

You must submit interim and final reportsSlide7

Three Main Parts to an IND

This starts as a protocol and growsSlide8

Investigators must sign form 1572

I agree…to make those records available for inspectionSlide9

Pre-study Activities

Sponsor/CRO Site Visit

Suitability of the Investigator for the protocol.Presence and experience of staff.Availability of patients.Availability of adequate facilities including patient exam rooms, a secure drug location, equipment, specialized instruments or devices required in the protocol. Slide10

Pre-Study Activities

Internal Site Evaluation

Is the study of interest to us?Do we have the necessary staff and training?Do we have or can we obtain necessary equipment?Does patient recruitment seem feasible?What about the budget?Slide11

The investigator’s brochure is your bible

You will look here for the

protocol—that you must follow

Adverse events-adverse events not in this brochure are unexpected and may need to be reported differentlySlide12

ICH Good Clinical Practice Guidelines

Excellent overview accepted for foreign as well as US trials

Useful set of recommended documents at

This is the standard to which

you will be audited

http://

www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6_R1/Step4/E6_R1

__Guideline.pdfSlide13

Be aware of regulations governing recruitmentSlide14

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Documentation Is Important!

Keeps track of events and data

Keeps track of steps in procedures

Keeps track of who administers tests

Keeps track of unplanned events

formsSlide15

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Case Report Form

Source documentSlide16

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Make it easy for the

staff

–

avoid mistakes

Gray out areas that should NOT be filled

Have consistent format: date, time, order, font.

Date

Test 1

Test 2

2 weeks prior

Day 1

2 weeks

4 weeks

Walk the coordinator through the questions:

2. For male subjects, skip to question 5.

3. Is the subject of childbearing age? Yes No

4. If yes, if the subject employing adequate contraceptive protection?Slide17

What happens during an audit

?

What do you mean,

the FDA is here!!???

Routine audits

For cause auditsSlide18

Where are areas of focus?

Look to warning letters for insights

Informed consent

Product accountability

Protocol integrity and deviations

Protocol design and change control

Source records and case report formsSlide19

Form 1483Slide20
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Complaints to CDER

Complaints lead to inspections about 30% of the time

Most complaints are come from drug sponsors and monitors, followed by private citizens

The complaints

most likely to trigger inspections come from participantsSlide22

If you are the investigator/sponsor…

You have reporting responsibilities to FDA

Be sure that you are sending your adverse events to the FDA according to rulesEnsure that you have sent changes in protocol to FDA and IRBEnsure that your informed consent form has been updated with any changes in riskSlide23

Think about test and control articles

AccountabilityRandomization adherence

http://apps.who.int/medicinedocs/documents/whozip10e/p08b.gifSlide24

Train your staff

They know the informed consent processThey know the way to deal with adverse eventsThey know the protocolThey have signed the staff listSlide25

Courses are available…

For example…MPTX 517

Structure and Management of Clinical TrialsMPTX 522Clinical Design Slide26

http://regulatory.usc.edu