Presentation on the Clinical trials. topic included by PCI to the master's course in Pharmaceutics

1. Guided by
Gavhane Y.N.
(Department of Pharmaceutics)
Presented by
Somani R. M.
(M.Pharm F. Y.)
Government College of Pharmacy,
Karad

2. CONTENT
• INSTITUTIONAL REVIEW BOARD.
• HIPAA.
• PHARMACOVIGILANCE.
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3. INSTITUTIONAL REVIEW
BOARD
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4. DEFINITION
IRB/IEC serves as an independent body that reviews,
evaluates, approves and decides on the scientific and
ethical aspects of the clinical trial protocol as well as
the benefits and risks to the study participants.
PURPOSE
Main purpose of IRB/IEC is to protect the rights, safety,
and well-being of the subjects who participate in a trial.
* Independent Ethics Committee
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5. COMPOSITION OF IRB/IEC
Consists of members, who collectively have the
qualifications and experience to review and evaluate
the science, medical aspects, and ethics of the
proposed trials.
Includes at least five members, of which at least one
member whose primary area of interest is
nonscientific, and at least one member who is
independent of the institution/trial site
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6. RESPONSIBILITIES OF IRB/IEC
• Reviews a proposed clinical trial within a reasonable time
and document its views in writing.
• Safeguard the rights, safety, and well-being of all trial
subjects.
• Conducts continuing review of each ongoing trial at least
once per year.
• Ensures that information regarding payment to subjects
(including the methods, amounts, schedule of payment) is set
forth in the written informed consent form and any other written
information is provided to the subjects.
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7. PROCEDURES OF IRB/IEC
Determines its composition and authority under which it is
established
• Schedules, notifies its members of, and conducts its meetings
• Conducts initial and continuing review of trials
• Specifies that no subject should be admitted to a trial before the
IRB/IEC issues its written approval/favorable opinion of the
trial
• Specifies the information that the investigator should
promptly report to the IRB/IEC (like deviations from the protocol,
adverse drug reactions etc.)
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8. MAINTENANCE OF RECORDS OF
IRB/IEC
• IRB/IEC retains all relevant records (e.g., written
procedures, lists of occupations/affiliations of
members, submitted documents, minutes of meetings,
etc.) for a period of at least 3 years after completion
of the trial and makes them available upon request
from the regulatory authority.
• IRB/IEC may be asked by investigators, sponsors, or
regulatory authorities to provide copies of its written
procedures and membership lists
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9. HIPAA
“Health Insurance Portability part of the Act”
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10. INTRODUCTION
• The privacy of health information becomes an important
concern for all intuitions delivering healthcare.
• The shift toward interoperable electronic health record
leads patients to worried about their information privacy and
losing of control over their data .
• The healthcare provider’s need to ensure effective level of
privacy and security policies that safeguard the patient’s
rights .
• The first and most considerable Federal legislation on
health privacy and security is the Health Insurance
Portability and Accountability Act known as the
HIPAA
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11. OBJECTIVES
• The first part “Health Insurance Portability part of
the Act”
• To ensure that individuals would be able to maintain
their health insurance between jobs.
• The second part of the Act is the "Accountability“
portion. To ensure the security and confidentiality of
patient information/data and mandates uniform
standards for electronic data transmission of
administrative and financial data relating to patient
health information.
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12. HIPAA BASICS
1.Covered Entities
• It safeguard all patient data of any form.
Excluding some areas, the protected health
information comprises of personal health data sent in
any form
✓ Health plans,
✓ Healthcare clearinghouses
✓ Health care providers doctors, nurses, and
therapists.
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13. 2.Protected Health Information (PHI)
• HIPAA protects all patient information whether it is verbal, written
or electronic.
• It includes all individually identifiable health information that is
transmitted or maintained in any form or medium.
• It includes demographic information that ties the identity of the
individual to his or her health record.
• E.g. names, addresses, geographic codes smaller than state, all
dates (except year) elements related to the person, telephone
numbers, fax numbers, license numbers, social security numbers,
etc.
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14. PHARMACOVIGILANCE
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15. INTRODUCTION
• Pharmacovigilance (PV) is the pharmacological
science relating to the detection , assessment
,understanding and prevention of adverse effects,
particularly long term and short term side effect of
medicines.
• All medicines (pharmaceutical and vaccines) have
side effect some are known many are still unknown
even this medicine has been in clinical use. The
important to monitor both known and unknown side
effects of medicines in order to determine any new
information in relation to their safety profile.
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16. AIM AND OBJECTIVES OF
PHARMACOVIGILANCE
Aim:-
• To identifying new information about hazards as
associated with medicines
Objective:-
• Improve patient care and safety
• Improve public health and safety
• Encourage safe, rational and appropriate use of
drugs
• Promote understanding, education and clinical
training in pharmacovigilance
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17. ADVERSE DRUG REACTION
• which is noxious ,unintended and which occurs A
response at doses normally used in humans for
Prophylaxis, Diagnosis or Therapy of disease , or for
modification of physiological function.
SIDE EFFECT
Any unintended effect of a pharmaceutical product
occurring at normal dosage which is related to the
pharmacological properties of the drug. e.g.
antihistamines producing sedation , anticholinergics
producing dryness.
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18. PHARMACOVIGILANE AND INDIA
India is a hub of Global Clinical trials & a destination
for Drug Discovery & Development. However, whether
patients in India receive safe drugs or not is still very
Much in question.
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19. WHO SHOULD REPORT SAFETY
DATA
• Physicians
• Pharmacists
• Pharmaceutical companies qualified persons.
• In many countries patients are encouraged
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20. WHAT TO REPORT
• It is important to report serious unexpected ADRs.
• Most cases of unexpected ADRs are associated
with medicines newly introduced on the market.
• All suspected adverse reactions.
• Every single problem related to the use of a drug.
• ADRs associated with radiology contrast media,
vaccines, diagnostics, drugs used in traditional
medicine, herbal remedies, cosmetics, medical
devices and equipment.
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21. IMPORTANCE OF
PHARMACOVIGILANCE
• Complete safety data (especially for
unexpected and serious adverse events) can
only be captured through
pharmacovigilance.
• It cannot be captured through clinical trials
which are conducted in an “artificial
environment”
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22. THANK
YOU
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