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    Muhammad Ikram Rabbani
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    This document provides an overview of clinical trials, including what they are, their purposes and types, personnel involved, protocols, regulations, informed consent, institutional review boards, patient recruitment, data collection, adverse events, phases, randomization, and blinding. The key points are: - Clinical trials are research studies that test new medical treatments or interventions on human volunteers to assess safety and efficacy. - They aim to answer specific questions about treatment effectiveness, safety, dosing, and quality of life effects. - Trials involve physicians, nurses, pharmacists, data managers and human subjects. They follow detailed protocols and are highly regulated internationally and by national bodies.

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    This document provides an overview of clinical trials, including what they are, their purposes and types, personnel involved, protocols, regulations, informed consent, institutional review boards, patient recruitment, data collection, adverse events, phases, randomization, and blinding. The key points are: - Clinical trials are research studies that test new medical treatments or interventions on human volunteers to assess safety and efficacy. - They aim to answer specific questions about treatment effectiveness, safety, dosing, and quality of life effects. - Trials involve physicians, nurses, pharmacists, data managers and human subjects. They follow detailed protocols and are highly regulated internationally and by national bodies.

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    22 views38 pages

    Clinical Trial Process

    Uploaded by

    Muhammad Ikram Rabbani
    This document provides an overview of clinical trials, including what they are, their purposes and types, personnel involved, protocols, regulations, informed consent, institutional review boards, patient recruitment, data collection, adverse events, phases, randomization, and blinding. The key points are: - Clinical trials are research studies that test new medical treatments or interventions on human volunteers to assess safety and efficacy. - They aim to answer specific questions about treatment effectiveness, safety, dosing, and quality of life effects. - Trials involve physicians, nurses, pharmacists, data managers and human subjects. They follow detailed protocols and are highly regulated internationally and by national bodies.

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    of 38

    Clinical Trials

    Dr. Madeeha Khalid


    Department of Biochemistry
    University of Okara
    What is a Clinical Trials?

     Clinical trials are prospective biomedical or behavioral


    research studies on human participants
     To answer specific questions
    What Is a Clinical Trial?

     Effectiveness of intervention to treat a disease


     Safety of a new drug
     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
    Personnels Involved

     Human Subject Volunteers


     Physician Investigators
     Research Nurses
     Pharmacists
     Lab Techs
     Social Workers
     Data Managers
    Research Protocol: Roadmap

     Detailed Research Plan that Includes:


     Objectives
     Background and Rationale
     Subject Selection Criteria
     Treatment Plan
     Study Procedures
     Response Evaluation Criteria
     Statistical Section
    Human Research is Highly
    Regulated
     National Regulations
     International regulations
    International Regulation

     E6 Good Clinical Practice (GCP): Consolidated Guidance


     International ethical and scientific quality standard for
    designing, conducting, recording and reporting trial
    results.
    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
    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.
    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.
    The Randomization Process

     The randomized clinical trial is the standard by which


    all trials are judged

     In the simplest case, randomization is a process by


    which each participant has the same chance of being
    assigned to either intervention or control
    Purposes of Randomization

     To generate comparative groups

     To enable valid statistical tests


    Blindness

    • Open label (unblinding)

    • Single blinding (patients only)

    • Double blinding (patients and investigators)

    • Triple blinding (patients and investigators and


    Monitoring investigators)
    Phases

     Pre clinical (animal)


     Phase 1
     Phase 2
     phase 3
     Phase 4
    Pre clinical

     Cell studies
     first tests done on a new treatment
     human cancer cells or animal cancer cells.
     Animal studies
     tested next on cancers in live animals
    Phase 0

     a few small doses of a new drug in a few people


     Initial drug interaction and response to the drug
     extra tests such as biopsies, scans, and blood samples
     Phase 0 studies aren’t widely used
     10-15 people
     Microdosing study
    Phase 1

     First few people in the study get a very low dose and
    monitored closely
     what the drug does to the body and what the body does
    with the drug.
     Safety is the main concern
     rare side effects may not be seen due to low sample
    size
     Placebos (inactive treatments) are not used in phase I
    trials.
     Include a small number of people (20-40)
     ADME studies
    Phase 2

     A group of 25 to 100 patients with the same type of


    disease upto 300 subjects
     using the dose and method found to be the safest in
    phase I studies.
     everyone gets the same dose
     Placebos (inactive treatments) are not used in phase II
    trials.
     Exploratory studies
     Hypothesis testing
     Therapeutic effect
     Proves primary hypothesis
     Efficacy
     Effect size
     Adverse events
    Phase 3

     Randomized double blind


     a large number of patients, at least several hundred to
    thousand
     Often done in many places across the country (or even
    around the world)
     offered in local community hospitals and doctor's
    offices.
     last longer than phase I and II studies.
     Placebos may be used
     Confirmatory trials
     Definitive proof of safety
     Additional safety data
     Adverse effects on prolonged uses
     Marketing of drug
    Phase 4

     look at drugs or therapies that have already been


    approved
     drugs are available for doctors to prescribe for patients,
     answer important questions still needed

     involve thousands of people.


     safest type of clinical trial because the treatment has
    already been studied a lot
     safety over time.
     These studies may analyze effects on quality of life or
    cost effectiveness.
    Trials in special population

     Pregnant and nursing women


     Children
     Geriatric patients
     Organ dysfunction patients
     Ethnic group
    Regulatory Body in Pakistan

     DRAP
     Clinical trials registry
     Clinical trials subject registry
    Therapies currently awaiting
    approval
    Diseases as candidates for
    gene therapy
    Trends in the use of vectors

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