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Clinical Trial Process: Overview

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Clinical Trial Process: Overview Clinical Trial Process: Overview Presentation Transcript

  • Clinical Trial Process: An Overview
    Dennis R. DeRosia, PA, MA
    Director, Business Development
    Profil Institute for Clinical Research
    dennis.derosia@profil-research.com
    Past President & COB
    Association of Clinical Research Professionals
    www.acrpnet.org
  • What Is a Clinical Trial?
    Effectiveness of intervention to treat a disease
    Safety of a new drug or device
    Defining dose administration
    Testing drug formulation
    Exploring combination therapies
    Evaluating effect of therapies on quality of life
  • Types of Clinical Trials
    Treatment
    Test new approaches to treat a disease
    Prevention
    What approaches can prevent disease
    Early-detection/screening
    What are new ways to find hidden disease
    Diagnostic
    How can new tests or procedures ID disease
    View slide
  • Phases of Drug Development
    View slide
  • Who are the Players?
    Human Subject Volunteers
    Physician Investigators & Staff
    NIH – National Institutes for Health
    Manufacturing companies (Sponsor)
    OHRP - Office for Human Research Protections
    FDA – Food & Drug Administration (CDER, CBER, CDRH)
    Settings: Academic, Private Practice, Professional
  • Evolution of Regulations
    1938 – Food, Drug & Cosmetic ACT
    1962 – Kefauver-Harris Amendment
    1968 – Drug Efficacy Study Implementation
    1981 – IRB Review Required
    1983 – Orphan Drug Act
    1997 – ICH-E6 Good Clinical Practice (GCP)
    1998 – Pediatric Rule
    2000 – NIH launches www.clinicaltrials.gov
  • Human Research is Highly Regulated
    Code of Federal Regulations (CFR)
    Title 21- Food and Drugs
    Part 50 Informed Consent
    Part 56 IRB
    Part 312 IND
    Part 314 NDA
    Part 600, 6001 Biologics
    Part 812, 813, 814 Medical Devices
    Title 45- Public Welfare
    Part 46 (subparts B, C, D) DHHS, Protection of Human subjects
  • What About International Regulation?
    International Conference on Harmonization
    E6 Good Clinical Practice (GCP): Consolidated Guidance
    International ethical and scientific quality standard for designing, conducting, recording and reporting trial results. (US, EU & Japan)
  • Why is Human Research Highly Regulated?
    Past transgressions lead to the need for laws that protect the rights and welfare of human subjects.
    Nuremberg Doctors Trial of 1946 (Nuremberg Code)
    Thalidomide Tragedy (Kefauver-Harris Amendment)
    Tuskegee Experiments (Belmont Report)
    Human Radiation Experiments
    Gene Transfer Experiment
  • Research Protocol: Roadmap
    Detailed Research Plan that Includes:
    Objectives
    Background and Rationale
    Subject Selection Criteria
    Treatment Plan
    Study Procedures
    Response Evaluation Criteria
    Statistical Section
  • Protocols
    A Phase I, Double-blind, Placebo-controlled, Dose-escalation Study of the Safety and Pharmacokinetics of Drug A31 in Subjects with Type 2 Diabetes Mellitus
    A randomized, double-blind, placebo-controlled study assessing the effect of (study drug) Controlled-Release Tablet on hypoglycemia in type 1 diabetic subjects intensively treated with insulin
  • Protocol Mouthful
    A PHASE 1, RANDOMIZED, PLACEBO-CONTROLLED, SEQUENTIAL PARALLEL GROUP, MULTIPLE DOSE ESCALATION TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF 28 DAYS OF ADMINISTRATION OF ND- 00254 TABLETS TO SUBJECTS WITH TYPE 2 DIABETES MELLITUS
  • Study Flow Chart
  • Study Flow Chart
  • Institutional Review Board(IRB)
    All clinical trials must be approved and monitored by an IRB.
    IRB is an independent committee of physicians, nurses, statisticians, community advocates and others.
    The function of the IRB is to ensure that a clinical trial is ethical and the rights welfare of study participants are protected.
  • Informed Consent
    Learning the key facts about a trial before deciding whether to participate.
    Research study purpose
    Risks/Benefits
    Alternative treatments
    Confidentiality of records
    Medical treatment available if injury occurs
    Whom to contact for answers to questions
    Statement that participation is voluntary
  • Patient Recruitment Challenge
    Poor patient recruitment is the number one reason that trials fail.
    Only 3 to 5 percent of newly diagnosed adult cancer patients participate in a clinical trial.
    Reasons for this relatively low number are many.
  • Recruitment Strategies
    Physician trust and contact
    Study staff contact
    Speaking to community groups
    Newspaper and radio Ads
    Internet websites
    Physician referrals
  • Subject Data Collection
    Data is collected on case report forms (CRF)
    Much of clinical data is taken from the subjects medical record (source documents)
    Pharmaceutical and device trials, data is verified by multiple players
  • Serious Adverse Events
    Events that results in any of the following:
    Death or life-threatening
    Hospitalization or prolonged hospitalization
    Persistent or significant disability/incapacity
    Congenital anomaly/birth defect
    Events that are serious, unexpected, and related or possibly related to participation in the research must be reported to the Sponsor, FDA and IRB in a timely manner.
  • Clinical Trial End Product
    Ideal: Unambiguous conclusion regarding the clinical outcome of the test treatment/device.
    Always strive for the ideal, but in most cases have to settle for the best comprise.
  • Positive-leaning articles tend to focus on gains made in fighting particular diseases.
    “Alzheimer’s vaccine study promising”
    “Treatment for cancer advances in trials”
    “A promising weapon in the fight against MS”
    * * * * * * * * * * * * * * * * * * * * *
    “Medical Miracles or Misguided Media”
    The Los Angeles Times
    “It sometimes seems as if there are Page 1 stories, television news reports and magazine cover stories almost daily on medical breakthroughs - new treatments for everything from the flu, obesity, AIDS and heart disease.”
  • News Update
    “Medical clinical research slows for lack of patients”
    Los Angeles Times – March 14, 2009
    • Enrollment problems delay more than 70% of clinical trials from one to six months
    • In cancer care, less than 5% of patients enter clinical trials
    • 700 cancer therapies in pipeline
  • News Update
    “It’s time to speed up drug approvals”
    The San DiegoUnion-Tribune – July 11,2008
    by Sally C. Pipes
    • FDA approved just 18 cancer drugs in past three years
    • CyberKnife shoots beams of radiation at tumors
    • Every day 1,500 Americans die from cancer
  • Coalition of National Cancer Cooperative Groups
  • Pay Attention to the Clinical Research Around You
    You may be the beneficiary some day!
    Thank you