Download Introduction to Clinical Research

Clinical Research
 Studies performed with human subjects to test new drugs
or combination of drugs, new approaches to surgery or
radiotherapy or procedures to improve the diagnosis of
disease and the quality of the life of the patient.
Importance of Research
 New techniques for screening and diagnosing a disease.
 New drugs to market.
 New methods for surgery.
 New approach for radiation therapy.
 New combination of standard treatments.
 New techniques, such as Gene Therapy.
Why do we need clinical trials?
 Evidence to prove the efficacy and safety in human beings.
 Only a well designed clinical study on a defined population
can give meaningful results about any therapeutic
intervention.
Types of Clinical Trials
 Based on researchers behave
 Observational Study
 Interventional Study
 Based on the Purpose
 Prevention Trials
 Screening Trials
 Diagnostic Trials
 Treatment Trials
 Quality of Life Trials
Ethical View
 International Conference on Harmonisation – Good Clinical
Practice (ICH - GCP)
 Independent Ethics Committee
 Institutional Review Board
 Informed Consent Document
Regulatory Guidelines
 Drugs & Cosmetics Act 1940
 Schedule Y
 Indian GCP Guidelines
 ICMR Guidelines
 WHO Guidelines
 ICH – GCP Guidelines
Players in Clinical Research











Sponsor
Investigator
Patients/Subjects
IRB / IEC
Regulatory Bodies
Pharma Companies
Contract Research Organizations
Clinical Research Associate (CRA)
Clinical Research Coordinator (CRC)
Data Manager
Statistician
Clinical Research Process
 Clinical Research Process includes:
 New Drug Development Process
 Pre – Clinical Testing
 Investigational New Drug Application (IND)
 Phase I (assess safety)
 Phase II (test for effectiveness)
 Phase III (large scale testing)
 Licensing (approval to use)
 Approval (available for prescription)
 Phase IV (special studies and long term effectiveness / use)
Drug Development Process
 Drug Discovery
 Target Identification
 Target Validation
 Lead Identification
 Lead Optimization
 Drug Development
 Pre Clinical Studies
 Phases of Clinical Trials
Pre Clinical Testing
 Before a drug can be tested in humans, pre clinical testing is
required.
 Pre Clinical studies conducted on animals.
 Laboratory and Animal studies are conducted to:
 Find out if there is a potential benefit of the drug, vaccine, or other
product
 Explore general safety concerns
 Duration: 3 – 4 years.
Investigational New Drug Application (IND)
 After completing preclinical testing, an IND must be filed:
 Describing the results of pre-clinical testing
 Clearly defining how future studies will be conducted
 The U.S. Food and Drug Administration (FDA) has 30 days
to review the IND.
Phase I Trial
 Also known as Human Pharmacology Study
 The goals of phase I clinical trials are:
 Assess safety for humans
 Select the dose to be used in future studies
 Population: 20 – 100
 Duration: Upto 1 year
 70% of experimental drugs pass this initial phase.
Phase II Trial
 Also known as Therapeutic Exploratory Trial.
 Used to evaluate the efficacy of the drugs or treatment.
 Population: 100 – 300
 Duration: Several months – 2 years
 30% of experimental drugs successfully complete both
phase I and phase II studies.
Phase III Trial
 Also known as Therapeutic Confirmatory Trial.
 To confirm its effectiveness and monitor side effects
 Population: 1000 – 3000
 Duration: Several Years
 70-90% of drugs or treatment that enter phase III studies
successfully complete testing.
Licensing
 After successful completion of all the 3 phases,
 New Drug Application (NDA)/Biologics License Application (BLA) is
filed with FDA.
 NDA/BLA must contain all scientific information compiled
over the course of the trials.
 FDA is allowed 6 months to 2 years to review the NDA/BLA
depending on the requirements.
 After FDA approves the NDA/BLA, the drug or treatment
becomes available for health care providers to prescribe.
 It must continue to comply with regulatory requirements
over time.
 Reviews continue to ensure safety over time.
Phase IV Trial
 Also known as Post Marketing Studies.
 The studies are designed to monitor:
 Long-term effectiveness and/or efficacy
 The impact on a person’s quality of life
 Some studies help determine the cost-effectiveness of a
therapy compared to other traditional and new therapies.
Who conducts the Clinical Trial?
 Investigators
 Principal Investigator
 Co - Investigator
Who Participates in the Clinical Trial?
 Subjects
 Healthy Human Volunteers
 Patients
 Having an active role in medical care
 Gaining access to treatments that are not publicly
available
 Having expert medical care at leading health
establishments throughout the trial
 Contributing to the advancement of medical research
Risks
 Having adverse side effects for the experimental
medical
intervention.
 Experiencing ineffective treatment and possibly one that
turns out to be worse than not being treated
 The protocol may require a lot of your time for tasks
associated with the trial, eg: trips to clinics, treatments and
hospital stays.
Thank You