CLINICAL TRIALFOR BPH 1ST YEAR
DR. PRAVIN PRASAD
RESIDENT 2ND YEAR, MD CLINICAL PHARMACOLOGY
MAHARAJGUNJ MEDICAL CAMPUS
23RD FEBRUARY, 2017 (FALGUN 12, 2073) THURSDAY
DRUG DISCOVERY AND DEVELOPMENT
• Drug discovery/synthesis
• Drug screening
• Preclinical Testing
• Evaluation in humans (Clinical trials)
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
CLINICAL TRIALS TYPES
• Prevention trials
• Screening trials
• Diagnostic trials
• Treatment trials
• Quality of life
trials (supportive care
trials)
OUTLINE OF THE PROCESSES FROM DRUG DISCOVERY TO MARKETING
DRUGS AFTER PHASE IV TRIAL
WITHDRAWN
• Rofecoxib
RESTRICTED USE
• Thalidomide
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)
ETHICAL CONSIDERATIONS
• Informed consent
• Confidentiality of Records
• Use of Financial Inducements in Drug Trials
• Approval from ethics committee/ IRB
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
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
POTENTIAL RISKS
• Side effects: unpleasant, serious, or even life-
threatening
• Ineffective treatment
• More time and attention than a standard
treatment
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)
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
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
THANK YOU
Top Related