Clinical trials & phases of clinical trials

Clinical trials & phases of clinical trials

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  CLINICALTRIAL & PHASES OFCLINICAL TRIALS
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  ClinicalTrial Any medicine deservingtrial in human is identified by Preclinical Study (animal study) the researchers approaches regulatory authorities, Who on satisfaction issue an licence for new drug development. It is formulated into a suitable dosage form and clinical trials are conducted in scientifically, phased manner to minimize any risk. In starting only few subjects receive the drug under close supervision. Later, larger number of subjects are treated with only relevant close monitoring.
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  Phase 1 • Itis also known as human pharmacology and safety phase. • Human administration of the drug is carried out in this phase by qualified physician in a facility where all vital functions are monitored and resuscitative facilities are available • Healthy volunteers are exposed to the drug (total 22-40 subjects). • Starting with the lowest dose and increasing to stepwise to achieve the effective dose • The main goal is on safety and tolerability while the purpose is to observe the pharmacodynamic effect in men • No blinding is done the study is open label
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  Phase 2 • Itis also known as therapeutic exploration and dose-ranging. • Conducted by physician, trained as clinical investigators. • Based on specific inclusion and exclusion criteria about 100 to 400 patients are selected. • The main aim is establishment of therapeutic efficacy, dosage range and ceiling effect in a controlled setting. • Tolerability and pharmacokinetics are studied. • Phase can be blinded or open labelled. • Carried out at 2-4 centre.
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  Phase 3 • Phaseis also known as therapeutic confirmation. • Randomised double-blind comparative clinical trial are conducted. • Patients population is 500 to 3000. • Main goal is to establish the effect of the drug in relation to existing therapy. • Safety tolerability and possible drug interaction are assessed on a wider scale. • Application for new drug is submitted to licensing authority if convinced give marketing permission.
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  Phase 4 • Thisphase is also known as post marketing surveillance studies. • After phase 3 drug has been marketed for general use, practicing physician are identified through whom data collected. • Data is collected on a structured performa about efficacy, acceptability and adverse effect of drug. • Uncommon adverse effect, suspected drug interaction and additional indication may merge from the surveillance data. • Further trial involving special group like childrens, elderly, pregnant may be undertaken at this stage. • Additional route administration, fixed dose drug combination may be explored.
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  Presented by Dr.V. K.Pathak ThankYou