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Developing a Clinical Research Program, Trial Design, Patient Enrollment. Gorav Ailawadi, MD Associate Professor Director, Minimally Invasive Cardiac Surgery Surgical Director, Advanced Valve Center University of Virginia AATS Grantsmanship Workshop March 8, 2013. Disclosures.

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developing a clinical research program trial design patient enrollment

Developing a Clinical Research Program, Trial Design, Patient Enrollment

Gorav Ailawadi, MD

Associate Professor

Director, Minimally Invasive Cardiac Surgery

Surgical Director, Advanced Valve Center

University of Virginia

AATS Grantsmanship Workshop

March 8, 2013

disclosures
Disclosures
  • No Relevant Disclosures
my background
My Background
  • Run a Basic Research Lab Studying Aneurysms
  • Faculty at UVA for 6 years
  • 80 papers during this time (over half are 1st or Senior author)
  • AATS Presentations (6), STSA (5), STS (3)
outline
Outline
  • Retrospective Studies
  • Prospective Studies
    • Randomized Trial
  • Trial Designs
  • Patient Enrollment

 Try to work on all three types as timing for results can vary

retrospective studies
Retrospective Studies
  • Often easiest to perform
  • May be Lowest Impact in terms of Changing Practice or Health Care
  • Majority of what is Presented at CT Meetings
retrospective studies research question
Retrospective Studies: Research Question
  • Relevant Questions- Pick a Topic you Truly are Interested in Result!
  • Seek Hypothesis where either Positive OR Negative result is Interesting
    • Does Payer Status Affect Outcomes?
    • Does prior PCI impact CABG?
    • Does STS Predict Mortality in Pulmonary Hypertension?
retrospective studies research question1
Retrospective Studies: Research Question
  • Try to Avoid reporting… “My last 100 cases…”
  • Center around a Question/ Hypothesis
  • Examples:
    • MELD in Tricuspid Valve Surgery
    • Redo AVR Has Improved Over Time
retrospective studies databases
Retrospective Studies: Databases
  • Know Strengths/ Weaknesses of Various Databases

Database Strength

Institutional Long Term Data

Regional (State) Access, Volume

National (STS, NIS, Medicare) Very High Volume

retrospective studies statistical support
Retrospective Studies: Statistical Support
  • Need Good Statistical Support
  • Understand Basics About Tests
  • Understand Statistical Lingo:
    • Multivariate, Propensity Matching, etc
  • Understand How to Report Stats to Surgical Community
retrospective studies final thoughts
Retrospective Studies: Final Thoughts
  • Ask Interesting Questions
  • Good Opportunity to Get Residents/ Students involved
  • Get IRB approval Early
  • Attempt to submit 2-3 Abstracts for each major meeting
how to get residents
How to Get Residents
  • Get Residents/ Students involved
    • Helps their career and yours
  • Be Responsive to Them (<48 hour Turnaround for Abstracts/ Papers)
  • Be Available to Meet for Guidance
  • Try to Help them get Talks on Meetings
prospective studies
Prospective Studies
  • Cleaner data than Retrospective
  • Potentially greater impact
  • Can be Used for Clinical or Translational Projects
prospective studies clinical examples
Prospective Studies: Clinical Examples
  • Investigation of Skin Preps
  • Smoking Cessation Program (Kozower)
  • Use of Wound Vac after sternotomy
  • Glucomander Use Postop

 Can often Study as a “Quality Project” instead of a “Trial” – can make IRB a little easier

prospective studies translational examples
Prospective Studies: Translational Examples
  • SurgeonsHave Access to Something NO ONE else has!
  • Any human tissue removed is useful for someone: Create a Tissue Bank!
    • Aneurysm, Plaque- Endarterectomy, IMA, SVG, Aortic Punch, LVAD Core, Heart, Lung Tissue, Esophagus
  • Useful for Your Own Lab or Collaborators
  • Work Hard to Get Tissue For Collaborators
    • Any Basic Science Project will be strengthened with Human Data
prospective studies planning
Prospective Studies: Planning
  • Make Goal Clear As Much As Possible
  • Power Analysis to Determine number of Patients (Underpowered prospective study will be a waste of your time)
  • Try to pick questions where either answer is relevant (choice between two approaches/ drugs)
prospective studies execution
Prospective Studies: Execution
  • Collect as Many patients as possible
  • Get complete data  may take sacrifice of your time
  • Get Help from you Research Team as much as you can
  • Consider Additional Sites
prospective studies designs
Prospective Studies: Designs
  • Phase I: Feasiblity and Early Safety Studies
    • New Drug
  • Phase II: Efficacy and Safety Trial
  • Phase III: Complete Trial designed to Reach Endpoint of Bringing Therapy to Market
prospective studies designs ii
Prospective Studies: Designs II
  • Phase IV: Post Market Studies (TVT Registry)
  • Adaptive: Study can evolve based on Interim analysis
    • Dose Escalation Studies
    • Expansion of inclusion criteria to Boost enrollment
prospective studies endpoints
Prospective Studies: Endpoints
  • Clinically Relevant
    • Survival, Reintervention, Recurrence of Disease
  • Surrogate Endpoint
    • End systolic volume index/ imaging
    • Biomarker
  • Symptomatic Endpoint
    • QOL
  • Disease Modification Endpoint
    • Reoperation
randomized studies
Randomized Studies
  • Most Powerful of Studies
  • Must be Carefully Designed
  • Time Intensive but Can be Highly Touted
  • Often require multicenter enrollment
patient recruitment
Patient Recruitment
  • Always harder than you expect/ takes longer
  • Patients want to hear from Surgeon about trial don’t leave enrollment to nurses
  • Must have Genuine Equipoise if Randomized Trial
  • Be Honest with Patients
  • Convince Patients you will do what is in their best interest 1st – They are not “guinea pigs”
patient recruitment ii
Patient Recruitment II
  • Get Word out about your study (websites, flyers, referring MDs, social media)
  • Make sure endpoints are realistic for patients
  • Get families involved in decision
  • Understand why patients Decline