suggestions are welcomed

1. CLINICAL TRIAL
FOR BPH 1ST YEAR
DR. PRAVIN PRASAD
RESIDENT 2ND YEAR, MD CLINICAL PHARMACOLOGY
MAHARAJGUNJ MEDICAL CAMPUS
23RD FEBRUARY, 2017 (FALGUN 12, 2073) THURSDAY

2. DRUG DISCOVERY AND DEVELOPMENT
• Drug discovery/synthesis
• Drug screening
• Preclinical Testing
• Evaluation in humans (Clinical trials)

3. DEFINITION
• Prospective biomedical or behavioral research study of
human subjects
• that is designed to answer specific questions about
biomedical or behavioral interventions
• in terms of their safety, efficacy and effectiveness

4. CLINICAL TRIALS TYPES
• Prevention trials
• Screening trials
• Diagnostic trials
• Treatment trials
• Quality of life
trials (supportive care
trials)

5. OUTLINE OF THE PROCESSES FROM
DRUG DISCOVERY TO MARKETING

6. DRUGS AFTER PHASE IV TRIAL
WITHDRAWN
• Rofecoxib
RESTRICTED USE
• Thalidomide

7. FUNDAMENTAL PRINCIPLES
• The rights, safety and well being of the trial
subjects should prevail over interests of science
and society
• Good clinical practice (GCP)
• Good manufacturing practice (GMP)
• Good laboratory practice (GLP)

8. ETHICAL CONSIDERATIONS
• Informed consent
• Confidentiality of Records
• Use of Financial Inducements in Drug Trials
• Approval from ethics committee/ IRB

9. WHY CLINICAL TRIALS ARE IMPORTANT
• “Evidence-based” patient care or prevention of disease
• To improve the quality of care
• Safety, efficacy of new treatment modality
• Compare new modality with available standard
treatments
• To increase knowledge

10. POTENTIAL BENEFITS
• Get actively involved in their health care
• Gain access to potentially new research treatments
• Access to expert medical care for the condition
being studied
• Help others by contributing to medical research

11. POTENTIAL RISKS
• Side effects: unpleasant, serious, or even life-
threatening
• Ineffective treatment
• More time and attention than a standard
treatment

12. CLINICAL TRIALS: CONDUCTED BY:-
• Government health agencies
• Researchers affiliated with a hospital or
university medical program
• Independent researchers
• Private industries/corporations (pharmaceutical
companies, biotechnology companies)

13. CLINICAL TRIALS DONE IN NEPAL
• Community Trial of Newborn Skin and Umbilical
Cord Cleansing on Neonatal Mortality in Nepal
• Ultraviolet Exposure, Antioxidant Use and Skin
Erythema at Extreme High Altitude
• Community and Health facility based Intervention
with Zinc as Adjuvant therapy for childhood
Pneumonia

14. CLINICAL TRIALS DONE IN NEPAL
• Effect of chlorhexidine cleansing on skin flora of
newborns in Nepal
• Multi-center trials for evaluation of fixed dose
combined tablet for the treatment of pulmonary
Tuberculosis

15. THANK YOU