clinicals trials

Typical protocol in phase I

• computer generated randomisation of volunteer

• Single blind

Volunteers recruitment criteria

• able to give informed consent

• Meet strict pre-defined inclusion criteria

• Free from disease and in general good health

Volunteer exclusion criteria

• Less than 18 years

• Over 55 years

• Recent participation in another trial

• Smoking taking OTC , herbal

First step :single ascending dose

• initial dose lower than predicted minimum

• Dose escalation if no serious effects

• Trial stopped when max dose or serious adverse effects

Second step: multiple ascending doses

• several doses given at pre-determined time intervals

• Same group of volunteers or a different group of

• ‘Cross over’ if same group

Optional 3rd step: effect of food on PK

• safe doses taken with high fat content meal

Primary objectives

DLT(dose limiting toxicities)

Recommended phase II dose

Secondary objectives

• toxicity profile

• PK

• PD

• Preliminary anti cancer activity (for anti cancer drugs)

Typical duration of phase I trials

12-18 months

Success rate of phase I

<70%

Phase II

• 100-300 patients with disease

• High homogeneity

• Diff doses and regimens tested

• Monitor side effects

Aim of phase II

Determine effective dosing regimens for phase III trials

Primary objective of phase II

Estimate clinical efficacy of a new treatment

Typical duration of Phase II

2 years

Success rate of phase II

<50%

Phase III trials

• broad patient ovulation with disease (1000-3000)

• Several hospitals

• Vey expensive

• Comparison with current treatment or placebo

Aim of phase III

Prove IND is ‘better’

Double blinded typical protocol

• advantage of comparing effects

• Effects of treatment must be short lived And reversible

• Sufficient washout period is used

Average development time from first-i-human study

8-10years

Overall success rate

10%

Phase IV

• after product has been approved

• Pharmacovigilance (post-marketing surveillance)

Aims of marketing ad promotion

• make medical nd scientific communities aware of the new drug

• Convince healthcare systems to adopt new drug

Roles of pharmacist in clinical trials

• dispense medicines for trials

• Safeguarding trial volunteers

• Data analysis

• Ensure proper storage and management of study files

• Ensure used per protocol following guidelines