Clinical development 2 Flashcards
Describe what occurs in phase 1 of clinical development?
Proof of principle
- Healthy volunteers
- safety and pharmacological effects
- Clinical pharmacology and biomarkers - 20-100 healthy volunteers (PK AND PD STUDIES)
- 1-1.5 YEARS
- 120 million
Describe what occurs in phase 2 of clinical development?
Proof of concept
- Test in Patients
- Dose-response
- Surrogate Efficacy (and Safety)
- 100-300 patients volunteers
- 2 years
- 140 million
Describe what occurs in phase 3 of clinical development?
Confirmation
- Lots of patients, trials and countries
- Surrogate or clinical end point
- Safety and efficacy (market access)
- 1000 - 5000 patient volunteers
- It confirms efficacy and approval of end points
- 3-5 years
- 300 million
Describe what occurs in phase 4 of clinical development?
Market support and access
- New indications
- Investigate safety concerns
- New doses
- Combination therapies
- Investigation of safety concerns
- Can be any size and cost
Who is involved in clinical drug development?
- Study team/ company or sponsor - National Regulatory Authorities
- Product team
- Senior management
- Chief medical officer
- Ethics committee
At what stages do you get regulatory affair interactions and how long does it take?
First in man within 30 days
Phase 2 before progressing to phase 3
End of phase 3 before phase 4
Takes 12-18 months
Who is involved and what does the study team do and their responsibilities?
Physician Scientists Statistician Project manager Study operation
- Writing the protocol to deliver the TPP and getting it approved in the company and outside
- Recruiting investigators and patients to time and budget
- Co-ordinating delivery of drug supplies and collection of samples
- Data collection and verification from sites – adverse event handling!
- Reporting
Who is involved and what does the product team do and their responsibilities?
Lawyers (IP) Clinical Delivery Patient safety Preclinical Scientist Regulatory specialist Manufacturer
- Writing TPP and getting it approved
- Agree functional plans and resources to deliver the TPP
- Deliver elements of functional plans to time and budget
- External discussions with RAs, Key Opinion Leaders
- Deliver Regulatory submissions and negotiate labels and approvals
Who is involved and what does the senior manager do and their responsibilities?
Provide:
- Oversight
- Alignment to company strategy
- Experience
- Resources
Who is involved and what does the chief medical officer do and their responsibilities?
Provide:
- Medical support and review
- Accountable for benefit risk of whole portfolio
What are the two different types of drugs; what are they and include examples?
- Small molecules - Synthetic chemicals / Traditional drugs, for example Oral, injected or topical
- Biologicals - Large complex peptides or proteins Produced by micro-organisms for example Usually injected or topical*
What is pharmacokinetics?
What the body does to the drug - ADME
can determine dose intervals, food and drug to drug interactions
What is pharmacodynamics?
What the drug does to the body - dose response curve
What are the different types of trial designs?
Parallel, cross over , ascending dose, real world and open
