Introduction to Clinical Investigation: Interface with Biomedical Industry

1. Introduction to Clinical Investigation:Interface with Biomedical Industry Mary Lee Vance, M.D.

2. 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

3. 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?

4. Interface with Biomedical Industry 3. Contract a. have reviewed by Dean’s office (Ms. Norma Miller) BEFORE doing the submission to Human Investigation Committee

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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)

11. 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.