Module Seven: Clinical Trials Flashcards
Clinical drug trials are human experiments on?
Efficacy and safety
Pharmacokinetics, health economics, quality of life
What is the purpose of phase 0 testing
To gather the first human pharmacokinetic and pharmacodynamic data safely at very lose doses
What is the aim of phase 1 testing?
To establish tolerable dose
Gather early data on human toxicity
What is the testing group for phase one clinical trials
Small, usually healthy volunteers
What are the aims of phase testing
To establish likely efficacious dose
Gather data in human toxicity at efficacious dose
What is the testing group for phase 2 trials
Patients with target disease - of sufficient size (up to 300) to make some conclusions about efficacy
What are the aims for phase three testing
Efficacy and adverse effects but with doses chosen and enough patients for high statistical power
Often includes quality of life, pharmacokinetics, pharmacoeconomics, pharmacogenomic too
Test groups for phase 3
Rep of target patient population
Aims of phase 4 clinical trials
Meshes the incidence of adverse effects
Test group for phase 4
As many treated patients as possible
Possible bias
Treatment bias
Observer bias
Selection bias
Overcoming bias
Placebos, active comparators and blinding
Membership of HREC
Researchers Lay people from outside institution Lawyer Clergyman or elder Doctor, nurse, councillor or other health professional
4 requirements of clinical trials
Research and merit integrity
Justice
Beneficence
Respect
How does everyone communicate
Investigators brochure
Protocol
Patient Information and consent
Event reports and results from trial
