Clinical trials First Year M. Pharmacy.

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

1. Clinical trials 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. 2

3. INSTITUTIONAL REVIEW BOARD 3

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 4

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 5

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. 6

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.) 7

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 8

9. HIPAA “Health Insurance Portability part of the Act ” 9

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 10

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. 11

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 . 12

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. 13

14. PHARMACOVIGILANCE 14

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. 15

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 16

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. 17

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. 18

19. Who Should Report Safety Data Physicians Pharmacists Pharmaceutical companies qualified persons. In many countries patients are encouraged 19

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. 20

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” 21

22. THANK YOU 22