Main players
AIM :
§ Steps of start-up and conduct of a clinical trial
§ Role of key players involved
Clinical research/ trial/ study
-> an investigation in human subjects
-> focus on safety and efficacy of pharma
-> focus on safety and performance of medical devices
Drug
-> a chemical that exerts certain desired effects on the body
-> they have plant, animal or biological origins
-> medication is for a cure, diagnosis, prevention, painkilling, anesthesia
Medical devices
-> the action of medical devices is not pharmacological, metabolic or immunological
Products which may be considered to be medical devices in some laws but not in others include:
§ disinfection substances
§ aids for persons with disabilities
§ devices incorporating animal and/or human tissues; devices for in vitro fertilization or
assisted reproduction technologies
DRUG -> pharmacological, immunological, metabolical -> function
DEVICE -> physical -> function
Drug development time line
We don’t use a healthy volunteer in case of a oncology (you start with a cancer patient)/ blood
pressure trial
Medical devices development
Complex clinical trial design
1
, -> has separate parts that could form individual clinical trials
-> and/or is characterized by prospective adaptions
-> planned additions of new investigational medicinal products (IMPs) or new target populations
-> most commonly used in oncology
GCP
1. Main players
sponsor
contract research organization (CRO)
o person or organization that offers services to sponsors or investigators to facilitate
various aspects of clinical trial related activities
o perform 1/more of sponsor’s clinical trial/ investigation related duties and functions
competent authority
o Belgium: FAMHP/FAGG/AFMPS
o Review of quality of the investigational product
ethics committee
clinical trial college
o responsibilities:
contact point for FAMHP regarding ethical committee comminication
appoint ethical committee for a trial review
supervise ethical committee
harmonize, support, evaluate and follow up on quality control of ECs
administrative support of ECs
advice on application of the regulation
investigator and team
subject
o investigational product/investigational device or control or an individual participates
in a clinical trial
Who is responsible -> sponsor or SITE
2
AIM :
§ Steps of start-up and conduct of a clinical trial
§ Role of key players involved
Clinical research/ trial/ study
-> an investigation in human subjects
-> focus on safety and efficacy of pharma
-> focus on safety and performance of medical devices
Drug
-> a chemical that exerts certain desired effects on the body
-> they have plant, animal or biological origins
-> medication is for a cure, diagnosis, prevention, painkilling, anesthesia
Medical devices
-> the action of medical devices is not pharmacological, metabolic or immunological
Products which may be considered to be medical devices in some laws but not in others include:
§ disinfection substances
§ aids for persons with disabilities
§ devices incorporating animal and/or human tissues; devices for in vitro fertilization or
assisted reproduction technologies
DRUG -> pharmacological, immunological, metabolical -> function
DEVICE -> physical -> function
Drug development time line
We don’t use a healthy volunteer in case of a oncology (you start with a cancer patient)/ blood
pressure trial
Medical devices development
Complex clinical trial design
1
, -> has separate parts that could form individual clinical trials
-> and/or is characterized by prospective adaptions
-> planned additions of new investigational medicinal products (IMPs) or new target populations
-> most commonly used in oncology
GCP
1. Main players
sponsor
contract research organization (CRO)
o person or organization that offers services to sponsors or investigators to facilitate
various aspects of clinical trial related activities
o perform 1/more of sponsor’s clinical trial/ investigation related duties and functions
competent authority
o Belgium: FAMHP/FAGG/AFMPS
o Review of quality of the investigational product
ethics committee
clinical trial college
o responsibilities:
contact point for FAMHP regarding ethical committee comminication
appoint ethical committee for a trial review
supervise ethical committee
harmonize, support, evaluate and follow up on quality control of ECs
administrative support of ECs
advice on application of the regulation
investigator and team
subject
o investigational product/investigational device or control or an individual participates
in a clinical trial
Who is responsible -> sponsor or SITE
2
