Clinical trials Flashcards
What are the phases in clinical trials?
- Pre-clinical testing
- Clinical research
- Final data analysis
- Follow up
Therefore the development of a drug is time-consuming and expensive
What is a clinical trial?
= series of tests that scientists ned to conduct when they come up with new ideas for new drugs, procedures or devices. Regulatory companies regulate approval of drugs and devices
Describe phase 1 of a clinical trial
To assess a safe and tolerated dose
To see if differ from animal to man
Detect any predictable toxicity
Uses healthy volunteers (unless exception using for anticancer drugs on healthy people)
- Excludes women of child bearing age
Small group of 20-25
- Start with dose of 1/10 to 1/5 tolerated animal dose and slowly increase the dose
If safe, increase group number
Performed by clinical pharmacologists and in a single centre
Takes 3-6 months with 70% success rate
Describe phase 2 of a clinical trial
First time in patients (not healthy volunteers)
Early phase - 20-200 patients with the disease to develop a dose range
Late phase - 50-500 patients using double blind with placebo
Assess efficacy against a therapeutic endpoint
Establishes a dose
Takes 6 months to 2 years - 35% success rate
Describe phase 3 of a clinical trial
Large scale, randomised and controlled trials
250-1000 patients
Performed by clinicals in the hospital
They are perfumed multicentric to ensure geographical and ethnic variations
Randomised allocation of test drug/placebo
Vigilant recording of all adverse drug reactions
Takes up to 5 years - 25% success rate
Describe phase 4 of a clinical trial
If the drug is successful, drug companies apply for licensing
Starts immediately after marketing
Report all adverse reactions
Helps to detect rare ADRs, drug interactions and new uses for drugs
Who is involved in a clinical trial?
Patients and healthy volunteers
Clinical pharmacologist
Institution where trials are held
Research ethics committee
- Supervises each step looking at welfare
Sponsor
- Pays for all expenses
- Ships all drugs for the trial
- Files all papers to legal authorities
Regulatory authority
What is the clinical trial protocol?
- Title and abstract
- Introduction
- Goals
- Study design
- Data analysis
What are the different types of study designs?
- Observation studies
* Cohort studies - followed over time, to investigate causes of a condition - Experimental/intervention Studies
- Evaluate the effects of an intervention - behaviour (walking for weight loss), drug or device
- Eg.:
- Parallel - simple vs placebo
- Crossover - comparison of each simple and placebo in each patient
- Can control the treatments
- But has carry-over effects, longer duration and more complex and smaller study
Describe step-by-step procedures of running an RCT
What are the steps in the running of a clinical trial?
What does a informed consent form need to consit of?
- Explained in simple language
- Translated in native language of the patient
- Comprehensive information regarding the trials
- All possible adverse reactions
- Freedom to withdrawal at any point
