Introduction to Clinical Trials
A clinical trial is defined as a prospective study comparing the effect or value of an intervention against a control in subjects. The core components of clinical trials are the population, intervention, control and outcome.
Clinical Equipoise
The genuine uncertainty within the scientific and medical community as to which of the two interventions is superior.
FINER Criteria
- Feasible (is it possible?)
- Interesting
- Novel (is it new?)
- Ethical - always the most important
- Relevant (does it matter now?)
Belmont Principles
Relevant to the ethics of research involving human subjects:
- Respect of persons - informed consent
- Beneficence - to do no harm
- Justice - Fairness among those chosen for the study
Possible Objectives of the Intervention
The new experimental intervention being tested usually has one of the following primary objectives:
- Cure a disease
- Reduce disease symptoms
- Prevent disease worsening
- Prolong survival time (terminal disease) or prevent disease (vaccine)
- etc.
Types of Intervention Studies
- Pharmaceutical products
- Synthetic drugs
- Biologics
- Products made from human or animal cell/tissue such as vaccines or blood replacement products
- Medical Devices
- Pacemaker, cardiac stents, etc
- Other (education, exercise, therapy, etc)