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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
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)
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)
CLINICAL RESEARCHRequirements Sponsor initiated study • IRB fee to review ($1,250) • GCRC use: inpatient & outpatient: sponsor assumes all costs
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)
CLINICAL RESEARCHRequirements • Cannot charge patients for any cost of industry sponsored studies • ? Current policy on conducting studies in outpatient clinic setting …
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)
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?
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)
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)
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
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
CLINICAL RESEARCHMulticenter Clinical Trial Publication • Authorship, order of authorship, control over final manuscript • Should be stated in the contract
CLINICAL RESEARCHMulticenter Clinical Trial Investigator Meeting • Required by FDA • 1-2 day session: review of protocol, requirements, discussion • Study coordinator also attends (CRF training)
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
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
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?
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
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!
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