How to Set Up and Begin Clinical
Research
Jeffrey M. Burns, MD
Associate Professor, Department of Neurology
Director, KU Alzheimer and Memory Program
Assistant Director, General Clinical Research Center
Challenges in Clinical Research
• Expensive
• Study people
– Difficulty controlling the exposure: type and
timing
– Clinical measures
• Recruitment
Clinical Trials vs. Investigator-Initiated
• Clinical Trials
– Regulatory hurdles
– Recruitment
• Investigator-initiated
– Protocol development
– Data management / analysis
– Funding
Initiating a Clinical Trial
• Regulatory
– HSC
• Consent form
– Contracts and budget
• Research Institute
• Recruitment plan
– Clinic
– Coordinator
Recruitment of Subjects
• Do not overlook this process (Your reviewers
will not)
• Often the most difficult aspect to successfully
implementing your plan (weakest link)
• Recruitment coordinator
• Detailed and well-thought out plan
Recruitment Plan
• Clinic recruitment
– Database created
• Brochures
• Media
– Radio shows (Walt Bodine, Steve Kraske)
– TV and Newspaper
– Press Release
• Alzheimer's Association
• Physician Referral
• Advertising
– Radio
– Newspaper
– Website
• Google keyword advertising
Phone Inquiry Form
Caller:
Relationship to Subject:
*Subject Name: ___________________________________________________________________
Last
First
Middle
*Address: _____________________________________
Gender: Male Female
______________________________________________
Date of Birth
______________________________________________
? Nursing Home ? Assisted Living
*Phone: Home (
)
Work (
)
Memory Problem: Yes
No
Gradual onset: Yes No
Gradual progression: Yes No
History of Memory Change:
Date of onset:
Medication for Dementia: Yes
Name of medication:
Date started:
No
*CS #1: Name:
Relationship:
Address : _______________________________________
______________________________________________
Phone: H (
W(
)
)
Continue to screen? Yes
No
*CS #2: Name:
Relationship:
Address: _______________________________________
______________________________________________
_______________________________________________
Phone: H (
)
W(
)
Reason if No:___________________________________
Data entered into a log for future recruitment opportunities
Investigator-Initiated Clinical Research
• Limiting Factors
– Money
– Participants
• Major Challenges
– Protocol development
– Data management plan
The Right Question
• Feasible
• The right balance of you and your
environment’s strengths AND limitations
– Important considerations:
• Your experience / preliminary data
• Your environment: utilize strengths  expertise and
equipment
– FINER
• Feasibility, Innovation, Novelty, Ethical, Relevant
The Aims Page
• Your roadmap
• One-page summary of the entire study
– Paragraph 1: rationale and overall hypothesis
– Aims – 3 to 5 main questions
• Evolving document
– Write and rewrite based on the process of
building your research project and input from
others.
Protocol
•
The evolution of a protocol from its initial version to the final
document creates a systematic approach to the development of
a clinical trial that is acceptable on ethical, scientific, and
organizational grounds.
•
The final version of a protocol should serve two primary
functions:
• Provide detailed specifications of the trial
procedure relating to each individual patient
• Describe the trial’s motivational background,
specific aims and rationale for the design
Slide courtesy of Holly Smith
Protocol
•
Main Protocol Features
1. Background and general aims
2. Specific objectives
3. Patient selection criteria
4. Treatment schedules
5. Methods of patient evaluation
6. Trial design
7. Registration and randomization of patients
8. Patient consent
9. Required size of study
10. Monitoring of trial progress
11. Forms and data handling
12. Protocol deviations
13. Plans for statistical analysis
14. Administrative responsibilities
Slide courtesy of Holly Smith
Measures / Outcomes
• Details, details, details
• Standardized
• Valid and Reproducible
Relationship of fitness with AD progression
• How to measure AD progression?
• Measuring fitness?
Data Management
• How will you collect the data?
– Paper, direct data entry
– What will be entered into a database and how?
• Source documents
• Case report forms
• Data entry plan, database structure
• Mistakes are inevitable
• Must make all forms and records as fool-proof as
possible
Source
Documents
Used to collect information
during the patient encounter
or performance of the study.
KU Brain Aging Project
EXERCISE VISIT/ METABOLIC ASSESSMENT
Date: _________________
Name: ____________________________________________________________________
First
Middle initial
Last
DOB: ___________________
Age: ________
BODY COMPOSITION
Test period:
Baseline
Time: __________ am/pm
Body Weight: ___________kg. (@ GCRC)
TECHNICIAN:
Body height: _________ mm. (@ DEXA)-CRF
___________ lb. (@ GCRC)
CIRCUMFERENCES
Small of Abdomen-narrowest point on the trunk)
(between zyphoid process and hips)
Gluteal (broadest hip area)
1.
cm.
1.
cm.
2.
cm.
2.
cm.
3.
cm.
3.
cm.
(Criteria 3 measurements each within 2.0 cm of each other)
Case Report Form
Used to extract most important data from source
documents for data entry / analysis.