Transcript Investigator-Initiated Clinical Research

Investigator-Initiated
Clinical Research
Planning, Developing, Conducting, Managing, and
Succeeding
Wm. Hirschhorn, M.S.
Director, OCT & RQI and
Adj. Prof of Regulatory Affairs
Office of Clinical Trials & Research
Quality Improvement
2-5245
2-3106
1
Objectives
• To begin to be able to …
– Describe the differences between
investigator-initiated clinical research
and sponsor-initiated clinical research.
– Successfully plan your own clinical
research project and assume ownership
for your work and achievement.
– Thoroughly develop your research
proposal.
2
Objectives
– Successfully initiate and conduct your
clinical research program.
– Comply with institutional, federal, and
other policies, guidances, and
regulations in managing your clinical
research program.
– Count on the Offices of Clinical Trials
and BioStatistics to assist you.
3
Isn’t Clinical Research All Alike?
• Basic science – NIH, bench-top and other. Grant
from department or government.
• Industry (sponsored) - initiated clinical
research. FDA regulated.
– Usually leads to marketing registration
• Investigator-initiated
research
– It’s your project - ownership!
– Various funding?
– Multiple responsibilities!!
4
(1) Examples of Investigator-Initiated
Research
•
•
Sponsor-Investigator or Investigator-IND
Investigator submits a Letter of Intent (LOI) to
industrial sponsor and OCT/BioStatistics
1. Your interest!!
2. Project proposal – You’re the expert
3. Technical and logistical support – Kinetics,
clinical/therapeutic section, investigational drug,
Drug Master File (Inv.-IND), GCRC, etc.
4. Address Federal regulatory requirements!!
–
OCT will help you
5. Human research participant population??
6. Possible funding??
7. Data ownership??
5
(2) Investigator-Initiated Research
Funded
• Proposal (LOI)
• Resources
• Application process
– NIH funded
– Refer to Dr. Steven Houser’s presentation titled
“Planning a Successful NIH Research
Application” (12/11/03)
• Other funding (for-profit, private sources)
• Publications??
6
(3) Institutional Supported Research
• Department funded – possibly no
outside funding
• LOI
• Resources
• Assistance from BioStatistics
• Assistance from OCT and GCRC
7
Remember!!
• Wherever you go, whatever you do - your
research needs should satisfy …
– Your unswerving attention and complete ownership
– Department chair’s
knowledge and approval
– Interaction with Sponsored
Projects
– Assistance from OCT
– IRB review and approval
8
Who is an Investigator?
(Sponsor-Investigator)
• An individual (not a corporation) who both initiates
(plans and designs) and conducts an investigation,
and under whose immediate direction the study drug
is administered or dispensed. Investigator IND.
21 CFR 312.3 and ICH E-6 (GCPs) 1.54
– Plans, designs, conducts, monitors, manages the
data, prepares reports, and oversees all regulatory
and ethical matters
– 21 CFR §312 Subpart D
• Absolute responsibility and
accountability required!!
9
So, how do you go about
doing this?
1. Take ownership
2. Devote sufficient time and initiative
3. Don’t lose focus of your objective
4. Ask yourself – “Do I really want to do this?”
5. Work with OCT & BioStatistics
6. Work with Sponsored Projects and the IRB
7. Plan for the long-haul
10
Steps to Success
• Development – Conduct – Management
– Chronological steps
• Project Development
–
–
–
–
–
–
•
•
•
•
Letter of Intent
Proposal
Timeline
Protocol development and data collection forms
Budget development
Funding
Contract
IRB review and approval
Study conduct and monitoring
Data Review and Analysis
11
Steps to Success
• What is the Letter of Intent (LOI)?
– Statement of your research interest in a
particular drug or device
– Your interest in conducting a clinical trial
with the drug or device
– Type of human research participant
population
– Anticipated time to conduct the trial
– Funding source, if known
– Who will supply the drug or device?
12
Steps to Success
• What should be contained in the LOI?
– Rationale for the proposed trial
– Design for the trial
• Dose, blinding, schedule, and comparison groups
– Characteristics of the population
– Patient enrollment feasibility
– Any unique features of the proposed trial
• Who would benefit from the new information?
– Patients
– Industry
– Temple
13
Steps to Success
• The LOI – Points to Consider
– Be clear, brief and to the point
– Avoid overuse of jargon
– Be unique
• Here creativity is appropriate
– Appeal to your audience(s)
– Follow all guidelines
– Show that you own the proposal
14
Steps to Success
• Developing the Protocol
– Format from company or OCT
– Build in flexibility
• Revisions will absolutely occur
– Make it informative
• Utilize the appendix section
• Supply important supplemental reading
– See BioStatistics for valuable assistance
• Consult with experts beside yourself
– Carefully edit the final edition
– Consult with OCT for template and IRB submission assistance
• What do I want to do with the data?
– Publication?
• Where? When? Requirements?
15
Steps to Success
• The Budget
– Think about the following things
• Department interest
• Industry interest
• OCT can assist in identifying outside sources
• Staff resources
– Co-investigator, CRC
– Consultants and resources (i.e., laboratory, special
services, data management, monitoring, technical)
• OCT benchmarks budgets successfully
• Complete the SPAF at the appropriate time
16
Steps to Success
• Some resources I need to identify?
– Clinical Laboratory and special lab support
– Therapeutic specialties (i.e., cardiology, D.I., G.I.,
etc
– Regulatory guidance
– Project management (i.e., QA, timeline adherence)
– Patient recruitment and advertising
– Data management
– Pharmacy
– Facility charges
– Computer support
17
Steps to Success
• Project timeline
– Development phase – Plan your work and
work your plan!
• Regulatory (IRB, FDA, NIH) and legal (contract)
• Project conduct phase
–
–
–
–
Recruitment
Trial conduct
Data collection
Data Quality Assurance
• Data review and analysis
• Publication
18
Steps to Ensure Success
• Study conduct and Monitoring
– KNOW YOUR OBLIGATIONS and
RESPONSIBILITIES
• Administrative
• Federal
• Temple, State and local
– Take charge of your project
• Champion your expertise
• Mentor
– See it through to completion
– Understand the requirement for monitoring and
Quality Assurance - OCT
19
Steps to Ensure Success
• Tips to ensure you have fun and succeed
– Frequently review your project for schedule
adherence
•
•
•
•
On-track in what areas?
Off-track in what areas?
Finances
Logistics
– Prepare for the worst case scenario
– Get use to paperwork – it’s a fact of life
– Unexpected delays or issues
• Count on this happening
• Identify the source
• Contingency planning – work with OCT/OCR
20
What’s next?
• In March 2004 – Investigator initiated
clinical research
– Data management and analysis
– Monitoring
– Quality Assurance
– Study outcomes
– Publications
• Other really exciting and useful topics
21