Introduction to clinical investigation interface with biomedical industry
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Introduction to Clinical Investigation: Interface with Biomedical Industry. Mary Lee Vance, M.D. Interface with Biomedical Industry. 1. How to get industry support: NEED A CONTACT a. investigator initiated study b. asked to participate in study, usually multicenter.

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Introduction to Clinical Investigation:Interface with Biomedical Industry

Mary Lee Vance, M.D.


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Interface with Biomedical Industry

1. How to get industry support: NEED A CONTACT

a. investigator initiated study

b. asked to participate in study, usually multicenter


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Interface with Biomedical Industry

2. Study protocol

a. scientific benefit? is the study design reasonable? does it have the potential for publication?

b. minimal scientific benefit: basically doing the study for financial reasons...can you afford the time/commitment?


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Interface with Biomedical Industry

3. Contract

a. have reviewed by Dean’s office (Ms. Norma Miller) BEFORE doing the submission to Human Investigation Committee


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Interface with Biomedical Industry

4. Budget negotiations

a. make sure all costs (hidden and overt) are covered

b. don't under estimate your time or research assistant's time

c. professional supervision a must (salary support)

d. overhead: U Va and departmental requirements: check before submitting budget


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Interface with Biomedical Industry

4. Budget negotiations (continued)

e. Laboratory charges: Clin Labs: 45% discount

f. ECG: can get discount for research, must request (Heart Center)

g. Radiology: may be able to get discount, need to ask radiologist...can usually get a discount if a radiologist is a co-investigator

h. Don't forget: patient travel, lodging, meals, parking


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Interface with Biomedical Industry

4. Budget negotiations (continued)

i. investigator travel charges: meeting to present data - negotiate this in advance

j. publication costs: include in budget

k. secretarial/mail/FAX/telephone: include in budget

l. GCRC: include all inpatient and outpatient charges, including hospital/outpatient fees, use of exercise laboratory, core laboratory, sleep laboratory


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Interface with Biomedical Industry

5. Patient Payment

a. clinical trial: patients not paid to participate; travel, lodging costs should be provided

b. normal volunteer study or pharmacokinetic study: volunteer and patient should be remunerated for time


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Interface with Biomedical Industry

6. Study Location

a. GCRC: industry sponsored study: must cover cost of bed/outpatient room/nurse time; if investigator initiated and funded by industry, no GCRC charges for use

b. Clinic: need to check with your clinic about charges


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Interface with Biomedical Industry

7. Publication

a. check the contract: the ms. may need to be approved by the sponsor before it can be submitted - problems have arisen with this clause (e.g.: UCSF investigator)


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Interface with Biomedical Industry

8. Provision of data to sponsor

a. CRF: case report forms: a "must" to complete in timely fashion, check for accuracy; corrections take more time than the original data entry

b. study monitor: most sponsors have someone to monitor progress of study, including review of patient charts, case report forms, drug supply (including dispensing records, pill counts)

c. laboratory certification: usually required, call Clinical Laboratories for the certificate

d. investigator CV: included with investigator agreement.


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