Good Clinical Practice (GCP)- Clinical research

LAB
Short Term Course
Free
Clinical research
  • 6 lessons
  • 1 quizzes
  • 6 week duration

Module 5

Phases and Mechanism of Clinical Trials

 

Another term known as a RCTs (Randomized Controlled trials) which gives us to elaborate the safety and efficiency of health arbitration such as vaccines, treatments, devices, and standard protocol or mechanism. The clinical trials could be happened employing healthy candidates and participants based on the investigating stage of the vaccine productions.

 

Clinical trials are generally completed in 4 phases:

 

Phase 1

Phase 1 test indulges the experimental or laboratory vaccine treatment in a small batch of healthy candidates for the initial period to analyze its safety and dosage scale or range, identification of side effects. Phase 1 commonly accepts the candidates between 50-100 range,

 

Phase II

Phase II test of trial vaccine conducted in a small group with some conditions or side effects to evaluate its effectiveness and to moreover analyze its safety. Phase II commonly indulges less than 100 candidates.

 

Phase III

Phase III of a trial vaccine or drug is conducted in the big scale or large batches of peoples to confirm the effectiveness, analyze small side effects and also compare with other given treatments and store the data which will allow the experimental or trial vaccine to be used safely.

 

Phase IV

Phase IV is analyzed as a surveillance stage and stores other data with valid information including the vaccine’s risk, advantages, and dosage range or optimal use. Phase IV will involve the general population.

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