Nuts and Bolts

1. Nuts and Bolts • Should you do a trial? • Resources • Contracts • Budgets • Study team • Space • Recruitment • Start-up • Forms • Compliance and follow-up • Money Matters • Closeout

2. Should You Do a Trial • Expensive • Difficult (recruitment, blinding, compliance, follow-up, etc) • Long - no between group comparisons until the end • Often funded by pharmaceutical companies

3. Should You Do a Trial, if... • You are approached by a pharmaceutical or device company… • is the question important? • is the protocol good (selection criteria) • will you have access to data for publication? • can you do the trial within the budget • You are asked to be project director • % salary support, effort, potential for pubs • You apply to the NIH and get money!

4. Funding Sources • Small trials • NIH - R-03 • Specialty organizations • AHA, ACS, ACOG, etc • Foundations • Pharmaceutical, device companies • Large trials • NIH - R-01, P-01, contract • DVA, AHCPR, CDC, DOD • Pharmaceutical, device companies

5. UCSF Resources • Senior colleagues in your field • Experienced trialists • Experienced trial staff • Consultants • data entry and management • statistical issues • Vice Dean for Clinical Research • Steven R. Cummings • Darlene Rosensweig (darlener@medicine.ucsf.edu)

6. Contracts • Required for pharmaceutical funding • Must be approved by UCSF Legal Services, the company’s legal division • lots of puzzling legalese • you should understand and revise • best to start with UCSF template, revise and submit to company • Between UCSF Regents and company • signed by PI

7. Elements of a Contract • Scope of work • Timetable for deliverables • Budget and timing of payments • get a bolus up front • don’t link payment to deliverables out of your control • Ownership of data and publishing rights • Rules for breaking contract • Confidentiality, indemnification • Patents and inventions

8. Budgets • NIH-style (NIH, VA, AHCPR, CDC) • prepared far in advance • governed by strict rules • funds restricted to categories • permission for carry over required • certain expenses not allowed • subject to government audit • Pharmaceutical company budgets • prepared just before trial starts • negotiable • rules much more flexible

9. Money Matters • Pre-award • prepare budget • help with budget justification • Post-award services • pay salaries, buy equipment and supplies • monthly report of expenditures • projections over life of trial

10. Who is the Study Team? • Principle investigator • Project director • Recruiter • Data manager • Programmer • Statistician • Administrative assistant • Financial/personnel manager

11. How to Hire the Study Team • Work with your department or unit personnel manager • write a job description • decide on job series, step, salary • post the job at UCSF and advertise • review resumes • interview • select

12. Where to Find the Study Team • Other studies • UCSF employees • Recent graduates, students • Friends and colleagues • Chronicle

13. Training the Study Team • Describe, emphasize and demonstrate the importance of: • following the protocol/OM • meeting recruitment goals • complete adherence and follow-up • full outcome ascertainment • maintaining participant safety and confidentiality • excruciating attention to detail • Darlene Rosensweig (darlener@medicine.ucsf.edu)

14. Training Meeting and Manual • Purpose and design of the trial • Measurements and visit procedures • methods • qualified personnel • calibration and testing • Completing and altering study forms • Data entry or submission • Safety issues

15. Team Management • Who has had a courses in this? • You are the boss • Keep your staff happy • involvement in the trial • salary, working conditions • level of responsibility • Staff interactions • Firing

16. Space • Considerations • accessibility, parking • design and decor • safety measures • COST • Clinical space • GCRC • Off-campus rental

17. Recruitment • Hire an experienced recruiter • Provide adequate time and money • Monitor results • Make changes • different approaches • more centers • longer recruitment • change eligibility

18. Recruitment • Referral from providers • hospital - special sites • clinic - PPOs • Advertise • hospital, clinics, special sites, churches • radio, newspaper • TV, internet • celebrities, leaders • Mail

19. Mailing • Targeted • Administrative, hospital, clinic, pharmacy, transplant, etc • identify likely eligible • use relationship with the list source • Mass • DMV, Voter Registration, HCFA • categorize by age, gender, +ethnicity

20. Start-up • Protocol • Operations Manual • Forms • Hiring • Training • Database design • Validation • CHR approval

21. Forms - A Very Big Deal • Define variables and importance • Determine method of data entry • Data entry by humans - more flexible forms, more effort for data entry • Machine readable forms - form design less flexible, less effort for data entry • Use prior forms - form library, contract • Pretest, validate

22. Compliance and Follow-up • Monitor rates • Obtain contact data • Pleasant, professional staff • Develop personal relationships • Encourage resumption of meds and return to follow-up • Cards, small gifts, meetings

23. Closeout • Final visit and post-trail • make final measurements • say goodbye and thank you • inform of test results • ?inform of treatment status • ?inform of trial results • ?make clinical recommendation

24. Summary • Trails are costly and complicated • get advice from experienced colleagues • use UCSF services • financial, legal, CHR • GCRC • statistical consultation • data management