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INTRODUCTION TO CLINICAL INVESTIGATION Interface with Biomedical Industry. Mary Lee Vance, M.D. Professor of Medicine and Neurosurgery Department of Medicine Endocrinology and Metabolism. CLINICAL RESEARCH Types of Studies.

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INTRODUCTION TO CLINICAL INVESTIGATIONInterface with Biomedical Industry

Mary Lee Vance, M.D.

Professor of Medicine and Neurosurgery

Department of Medicine

Endocrinology and Metabolism


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CLINICAL RESEARCHTypes of Studies

  • Investigator initiated: proposal submitted to industry sponsor - request drug, financial support or both

  • Sponsor initiated: usually a multicenter clinical trial; sponsor provides protocol, budget (must be negotiated)


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CLINICAL RESEARCHRequirements

  • All clinical studies: must be approved by Human Investigation Committee (IRB) – protocol & consent form

  • General Clinical Research Center: must be approved by GCRC Advisory Committee (reviewed before IRB review)


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CLINICAL RESEARCHRequirements

Sponsor initiated study

  • IRB fee to review ($1,250)

  • GCRC use: inpatient & outpatient: sponsor assumes all costs


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CLINICAL RESEARCHRequirements

Investigator initiated study

  • No IRB fee to review protocol

  • GCRC use: no charge for use of inpatient or outpatient facility (some lab charges may be covered, depending on cost – need to consult with GCRC administrator)


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CLINICAL RESEARCHRequirements

  • Cannot charge patients for any cost of industry sponsored studies

  • ? Current policy on conducting studies in outpatient clinic setting …


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CLINICAL RESEARCHIndustry Support

How to participate in a clinical trial?

  • Need a contact: ask your colleagues; contact research director of a company that is involved with your field….

  • Ask your “rep” if he/she knows of any planned studies (usually not helpful, but worth a try)


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CLINICAL RESEARCHMulticenter Clinical Trial

Items to consider BEFORE participation

  • Is the study scientifically valid?

  • Does it have potential for publication?

  • Is the budget adequate? (you don’t work for the pharmaceutical company)

  • Do you have the resources/time to participate?

  • Do you have patients you can enroll?


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CLINICAL RESEARCHMulticenter Clinical Trial

You decide to participate – Contract

  • Have the contract reviewed by Dean’s office before writing the protocol & consent form

  • U Va has specific requirements & will resolve contract issues directly with the sponsor (Betty Pincus is terrific)


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CLINICAL RESEARCHMulticenter Clinical Trial

You decide to participate – budget negotiations

  • The sponsor’s budget is usually inadequate

  • University overhead: 25%; ? Department overhead (10% for Dept. Medicine)

  • Protocol preparation & IRB review fees

  • Travel, lodging, parking costs for patients

  • Professional supervision (your salary support)


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CLINICAL RESEARCHMulticenter Clinical Trial

You decide to participate – budget negotiations

  • Patient payment: necessary if patient does not benefit from study (e.g. dose finding study or pharmacokinetic study)

  • Normal volunteer study: must pay for participation

  • Include: secretarial, mail, fax, telephone, publication costs


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CLINICAL RESEARCHMulticenter Clinical Trial

You decide to participate – budget negotiations

  • Laboratory: check on discount rate

  • Radiology: check on discount rate

  • ECG: check on discount rate

  • Will need to set up special billing for these charges; billed directly to your grant account


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CLINICAL RESEARCHMulticenter Clinical Trial

Publication

  • Authorship, order of authorship, control over final manuscript

  • Should be stated in the contract


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CLINICAL RESEARCHMulticenter Clinical Trial

Investigator Meeting

  • Required by FDA

  • 1-2 day session: review of protocol, requirements, discussion

  • Study coordinator also attends (CRF training)


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CLINICAL RESEARCHMulticenter Clinical Trial

Case Report Forms (CRF)

  • Sponsor sends monitor before, during & at completion of study to review records, queries

  • This takes more time than you think: consider adding line item in budget to cover your time; coordinator’s time


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CLINICAL RESEARCHMulticenter Clinical Trial

Laboratory certification

  • Sponsor requires documentation of certification for Clinical Laboratory (not a problem at U Va) – obtain certificate from Clinical Pathology


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CLINICAL RESEARCHMulticenter Clinical Trial

Study Coodinator

  • Full time: expensive, not always practical for a new investigator

  • Do you have the time to attend to details, paperwork?


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CLINICAL RESEARCHRewards

Cutting edge research; new treatments: examples: FDA approval:

  • GHRH physiology; treatment GH deficiency

  • 3 dopamine agonists for prolactin producing pituitary tumors

  • 2 somatostatin analogs for acromegaly

  • GH receptor antagonist for acromegaly

  • GH replacement in adults; depot GH

  • Transdermal testosterone, 2 drugs


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CLINICAL RESEARCHSummary

  • Advances clinical science (human beings: the ultimate in “translational research”)

  • Potential for new medical treatments, procedures

  • Requires a great deal of paperwork, but worth it!


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EFFECT OF OCTREOTIDE OR SOMAVERT

2100

Somavert (10 - 35 mg/day)

1800

Octreotide + Bromocriptine

1500

1200

IGF-I (ng/ml)

900

Gamma Knife

TSS

Radiosurgery

600

Normal Range

300

0

Jul-93

Jul-94

Jul-95

Jul-96

Jul-97

Jul-98

Jul-99

Jan-94

Jan-95

Jan-96

Jan-97

Jan-98

Jan-99

Jan-00

Time

GDM



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