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 No Name of medication: Date started: *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 environments 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 trials 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.
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