Primer clinical trial basics what you need to know to manage an industry sponsored clinical trial
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Primer: Clinical Trial Basics: What You Need to Know to Manage an Industry Sponsored Clinical Trial. Presenters:. Cheryl K. Williams, Associate Director, Office of Research and Project Administration, University of Rochester

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Primer clinical trial basics what you need to know to manage an industry sponsored clinical trial

Primer: Clinical Trial Basics: What You Need to Know to Manage an Industry Sponsored Clinical Trial


Presenters

Presenters:

Cheryl K. Williams, Associate Director, Office of Research and Project Administration, University of Rochester

Donna Galloway, Division Administrator, Infectious Diseases Division, University of Rochester

Doreen M. Francis, RN, CCRC, Vaccine Research Unit, Infectious Diseases Division, University of Rochester


Milestones in clinical trial and ethics development 1
Milestones in Clinical Trial and Ethics Development1

Research Ethics Milestones

Presidents Council on Bioethics

2000

National Bioethics Advisory Commission

1990

Common Rule

CIOMS Guidelines

HHS/FDA Human Subject Regulations

1980

Belmont Report

Trigger Events

Gene Transfer Subject Death

The Syphilis Study (Expose)


Presenters

Research Ethics Milestones

1970

Declaration of Helsinki

Kefauver-Harris Amendments 1960

1950

Nuremberg Code

1940

1930

Trigger Events

The Beecher Article (NEJM)

Milgram Study

The Thalidomide Tragedy

Human Radiation Experiments (begin)

The Nazi Experiments

The Syphilis Study (begins)

1Dunn, C.M., Chadwick, G.L. Protecting Study Volunteers in Research, Third Edition, p 27, (2004)


Game changers in clinical trials
Game Changers in Clinical Trials

  • Nazi Concentration Camp Atrocities

  • The Milgram Study – Obedience Study

  • The Thalidomide Catastrophe – Sedative

  • PHS Study of Untreated Syphilis in the Negro Male

  • Human Radiation Experiments – Plutonium Injections – Intentional Releases of Radiation

  • U Penn Gene Transfer Experiment - FCOI


Harmonization
Harmonization

Ideally, your institution has a central office to review, negotiate and approve clinical trials

Reality:

  • Central sponsored programs office negotiates clinical trial agreement (CTA)

  • IRB reviews, approves protocol and ICF

  • Department reviews, negotiates budget

    Possible Result: contradictory documents and bad timing – CTA negotiated, but IRB approval Missing or budget still under review


You know you re going to work on a clinical trial when
You Know You’re Going to Work on a Clinical Trial When . . .

  • Your PI brings a Confidential Disclosure Agreement (CDA) to you

  • Your PI starts talking about the patient base

  • Your PI leaves town to go to an investigators’ meeting in the Caribbean 

  • An unacceptable budget with an exceptionally expensive protocol lands on your desk


The cda see handout 1 for sample
The CDA . . – see Handout 1 for sample

Should be reviewed by your central office

  • Concerns:

    • Definition of confidential information – narrow the scope – eliminate any mention of intellectual property requirements – this is a CDA only

    • Time limit to hold confidential – 1 year standard (obligation no greater than 5-7 years)

    • Only the PI should be bound by agreement


The cda
The CDA . .

Should be reviewed by your central office

  • Concerns:

    • If a CTA results, it will supersede the CDA

      5. Believe it or not, Export Control – don’t accept any information that could be subject to this law

      6. Refuse to receive any trade secrets

    • Governing law


The cta see handout 2 for sample
The CTA . . – see Handout 2 for sample

Negotiated by the Central Office

Issues:

  • CTA with Institution, not PI

  • Signatories should be sponsor, Institution, with PI signing as “read and understood”

  • Statement of work section should reference attached protocol

  • Payment terms should reference attached negotiated budget


The cta
The CTA . .

5. Sponsor will supply drug/devise in sufficient quantity

  • Investigator and sponsor assure that study will be conducted in accordance with all laws and regulations

  • HIPAA

  • In an age of electronic everything, watch out for CFR, Title 21, Part 11, Electronic Records compliance


The cta1
The CTA . .

  • Time limitation on requirement to keep confidential

  • Under data ownership and IP, make sure all original records or work, including patient medical records, laboratory records and reports scans, films and pre-existing information in Institution’s databases remain Institution property – everything else belongs to sponsor

    11. Free to publish after sponsor review

    12. Site access – know what your institution will accept


The cta2
The CTA . .

  • Subject Injury – sponsor reimburses institution for cost of reasonable and customary medical treatment for any illness or injury sustained by subject

  • Insurance – get sponsor’s limits – remember, indemnification and subject injury are not limited by sponsor’s insurance limits

  • AAHRPP language, if required by your institution


The cta3
The CTA . .

19.WARRANTIES – institution should make no warranties, express or implied regarding the results

20.Governing law – should be your state’s


The protocol and informed consent form
The Protocol and Informed Consent Form . .

  • Protocol

    • Provided by sponsor

    • Usually in final version

    • Review for feasibility to assist in budget preparation and to compare with consent


The protocol and informed consent form1
The Protocol and Informed Consent Form . .

  • Consent

    • Template provided by sponsor

    • Modifications per institutional policy

  • SOP for Consent Process

    • Consent quiz used to confirm subject understanding and tool to aid discussion – see Exhibit C


Other considerations
Other Considerations . .

  • Protocol may need to be reviewed by others: Institutional Biosafety, ED Committee or other department review

  • Applications to be completed

    • 2 at our institution

      • Local IRB

      • WIRB

    • IBC

    • Research Match

    • Other committee-required applications


Other documents
Other Documents . .

  • Consent quiz (see Handout 3 for sample)

  • Phone screen

  • Advertisements

    • Email/internet

    • Newspaper/flyer

    • Radio TV spots

  • 1572


Other documents1
Other Documents . .

  • CV Assembly/Medical Licenses

  • Financial Disclosure form

  • Conflict of Interest statements

    • COI Management Plan if applicable


Other coordinator duties
Other Coordinator Duties . .

  • Set up any testing need with appropriate dept

    • Lab

    • X-ray

    • Cardiology, etc.

  • All this information must be in the budget!


The budget
The Budget . .

  • Event grid – used to develop budget

  • Event grid - populated with time and costs

    • Nurse time has been rounded (salary and benefits) to $50/hr)

    • PI time at $200/hr

  • Bullet list of pass-through costs

    See Handout 4 for samples