INTRODUCTION TO CLINICAL INVESTIGATION Interface with Biomedical Industry

1
INTRODUCTION TO CLINICAL INVESTIGATION Interface
with Biomedical Industry

• Mary Lee Vance, M.D.
• Professor of Medicine and Neurosurgery
• Department of Medicine
• Endocrinology and Metabolism

2
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)

3
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)

4
CLINICAL RESEARCHRequirements

• Sponsor initiated study
• IRB fee to review (1,250)
• GCRC use inpatient outpatient sponsor assumes
  all costs

5
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)

6
CLINICAL RESEARCHRequirements

• Cannot charge patients for any cost of industry
  sponsored studies
• ? Current policy on conducting studies in
  outpatient clinic setting

7
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)

8
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 dont work for the
  pharmaceutical company)
• Do you have the resources/time to participate?
• Do you have patients you can enroll?

9
CLINICAL RESEARCHMulticenter Clinical Trial

• You decide to participate Contract
• Have the contract reviewed by Deans office
  before writing the protocol consent form
• U Va has specific requirements will resolve
  contract issues directly with the sponsor (Betty
  Pincus is terrific)

10
CLINICAL RESEARCHMulticenter Clinical Trial

• You decide to participate budget negotiations
• The sponsors 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)

11
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

12
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

13
CLINICAL RESEARCHMulticenter Clinical Trial

• Publication
• Authorship, order of authorship, control over
  final manuscript
• Should be stated in the contract

14
CLINICAL RESEARCHMulticenter Clinical Trial

• Investigator Meeting
• Required by FDA
• 1-2 day session review of protocol,
  requirements, discussion
• Study coordinator also attends (CRF training)

15
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
  coordinators time

16
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

17
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?

18
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

19
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!

20
EFFECT OF OCTREOTIDE OR SOMAVERT
2100
Somavert (10 - 35 mg/day)
1800
Octreotide Bromocriptine
1500
1200
IGF-I (ng/ml)
900
Gamma Knife
TSS
600
Radiosurgery
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
21
Sugar My New Bulldog