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WITHDRAWN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