Introduction to Clinical Research
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Transcript 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