Hello Everyone!!!
I thought of sharing a short and simple overview of what clinical research is, especially for those who are new to the field or curious about how it works.
Clinical research involves studying health and illness in people. It includes trials that test new ways to prevent, detect, diagnose or treat diseases.
Clinical trials is a subset of clinical research specifically designed to evaluate the safety and effectiveness of investigational product (IP) - such as drugs, vaccines or medical devices- on human volunteers.
It’s done in different phases:
Phase 0- (Microdosing Phase)- Focuses on PK/PD
Phase I- (Human Safety Trial)- Focuses on tolerability, assess safety, dosage range
Phase II- (Exploratory Phase)- Evaluate effectiveness and futher assess safety
phase III- (Confirmatory Phase)- Confirms effectiveness, monitor Side effects
Phase IV- (Post marketing surveillance)- Monitoring long term safety, Rare SE
Each phase plays a crucial role in ensuring that only safe and effective treatments reach patients.
If anyone has questions about any of these phases or about clinical research in general, feel free to ask! I’d be happy to share what I know and also learn from your experiences.
