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Clinical Trials 101: What, How, and Why Clinical Trials Are Important To You, Your Family and the Co

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Clinical Trial Phases: Research Questions for new Cancer Treatment Trials. Design Features ... Diversity in Clinical Cancer Research Participation ... – PowerPoint PPT presentation

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Title: Clinical Trials 101: What, How, and Why Clinical Trials Are Important To You, Your Family and the Co


1
Clinical Trials 101What, How, and Why Clinical
Trials Are Important To You, Your Family and the
Community
  • Claudia R. Baquet, MD, MPH
  • Professor Epidemiology and Preventive Medicine
  • University of Maryland School of Medicine
  • PI NCI Maryland Regional Community Network
  • Director University of Maryland EXPORT Center
    (NIH P 60)

2
TAKE A QUIZ!!!
3
Clinical Trials Definition
  • A research study involving humans which may
    evaluate a new way to prevent, screen for,
    diagnose or treat a disease
  • Proceeds in Phases in an orderly sequence after
    laboratory studies
  • Some trials study new ways to improve quality of
    life for patients

4
Low Clinical Trials Participation
  • Only 3 cancer patients
  • Higher participation rates for privately insured
    and military including VA
  • Low participation rates
  • African Americans and other minority
  • Rural
  • Low income
  • Medicaid
  • Barriers to trial participation

5
Assuring Diversity in Clinical Research
Participation
  • A national priority
  • Minority, uninsured, poor, and rural communities
    have lower participation rates in medical
    research
  • Underserved communities experience substantial
    health disparities
  • Barriers community, patient, health
    professional, researcher, structural

6
Barriers To Clinical Research Participation
  • Less effective or ineffective physician-patient
    interactions
  • Insufficient community infrastructure to support
    clinical research and trials
  • Researcher-specific obstacles Lack of training
    in cultural factors and health disparities
  • Lack of community outreach support, absence of
    convenient transportation in rural and urban
    communities
  • Community and physician distrust of academic
    institutions
  • Lack of knowledge of role of clinical research in
    improving health, reimbursement concerns
  • Historical factors

7
University of Maryland School of Medicine
Clinical Trial Partnership Models
  • Community health professionals
  • physicians and nurses
  • rural and urban
  • Faith and community based organizations
  • Local health departments
  • Community hospitals
  • Policy makers

8
Clinical Trials Key Features
  • Carefully planned scientifically and ethically
  • Informed consent required written
  • Participation is voluntary
  • High quality health care provided to all
    participants

9
Clinical Trial Components
  • Protocol detailed action plan
  • Eligibility criteria
  • Endpoints
  • Tumor or disease response rate
  • Disease-free survival
  • Overall survival
  • Randomization
  • Stratification
  • Blinding
  • Data collection and management tools
  • Results dissemination

10
Clinical Trial Aspects
  • All aspects carefully planned
  • Random assignment
  • Blinding
  • All aspects carefully monitored
  • A participant may withdraw from a trial at any
    time

11
Types of Clinical Trials
  • Prevention
  • Early Detection/Screening
  • Treatment
  • Quality of Life

12
Clinical Trial Phases
  • Progress occurs in an orderly series of steps
    called Phases
  • Phase One
  • Phase Two
  • Phase Three
  • Phase Four

13
Clinical Trial Phases
14
Clinical Trial Phases Research Questions for new
Cancer Treatment Trials
  • Clinical trials occur in four phases, each of
    which is designed to answer different research
    questions
  •  
  • Phase 1 How does the treatment affect the human
    body? How should the treatment be given? What
    dosage is safe?
  •  
  • Phase 2 Does the treatment do what it is
    supposed to do for a particular cancer? How does
    the treatment affect the human body?
  •  
  • Phase 3 Is the new treatment (or new use of a
    treatment) better than current practice?
  •  
  • Phase 4 What are the effects of an approved
    treatment?
  •  

15
Design Features
  • Controlled Trial
  • At least two arms
  • Control or comparison group
  • Experimental or new treatment group
  • May have another drug, treatment or other
    intervention to be evaluated
  • Reduce bias so results are accurate!!!

16
Design Aspects
  • Placebo rarely given in treatment trialcompares
    standard care with new form of treatment
  • Sponsors
  • Government
  • Industry
  • Cancer center
  • Other institution

17
Barriers to Participation in Clinical Research
  • Patient
  • Community
  • Health Care Professionals
  • Investigator
  • Research Institution
  • Health System

18
Barriers for Health Care Professionals
  • Lack of awareness of appropriate trials
  • Lack of available trials in community settings
  • Unwillingness to lose control of a persons care
  • Belief that standard therapy is best
  • Belief that referring to and/or participating in
    a clinical trial adds to administrative burden
  • Concerns about the persons care or how the
    person will react to the suggestion of clinical
    trial participation

19
Barriers for General Population
  • Lack of awareness of clinical trials
  • Lack of access to trials
  • Fear, distrust, or suspicions of research and
    academics
  • Practical or personal obstacles
  • Insurance or cost problems
  • Unwillingness to go against personal physicians
    wishes

20
Diversity in Clinical Cancer Research
Participation
  • Cancer rate disparities exist for certain
    populations
  • Representation of minorities and the poor is
    lower than for the general population
  • Low participation in trials may contribute to low
    cancer survival rates
  • NIH mandate and national initiatives to increase
    minority accrual to trials

21
Questions To Ask
  • What is the research evidence that led to this
    trial? Why is this being studied?
  • What type of trial and the Phase?
  • How long is the study?
  • Do I receive medical tests and how often?
  • Is insurance coverage needed?
  • What are the possible benefits and risks?
  • How are participants protected?
  • Explain the written informed consent form
  • Where can I find information?
  • If I agree to participate
  • Who do I call if I have a problem during the
    trial?
  • Can I see my regular doctor while in a trial?
  • If I need transportation, will the clinical trial
    center provide this?

22
Maryland Clinical Research Partnership Model
  • National HHS Best Practice Award
  • A Model For Increasing Availability Of
    Community-Based Cancer Clinical Trials In Rural
    Eastern Shore Maryland, September 2004
  • ASHBESTPRACTICES_at_LIST.NIH.GOV
  • Claudia Baquet, MD and Mary DeShields, MD

23
Resources
  • Clinicaltrials.gov
  • NIH listing of active and inactive trials
  • Disease and geographic specific
  • Details, eligibility criteria, population size,
    contact information
  • Cancer.gov
  • Cancertrials.gov
  • www.mdhealthnetwork.org
  • 410-706-1709
  • 1-800-4-CANCER or 1-800-ACS-2345

24
TAKE A QUIZ!!!
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