Four(4) Phases of a Clinical Trial Research Paper
1.What are the four(4) phases of a clinical trial? In nursing research, the two(2) most common types of cost analysis are? 2. In quantitative research what is the difference between accessible and target population? What is the difference between probability and nonprobability analysis sampling? What are the four(4) steps in sampling in quantitative research?
Clinical trials are a type of research that studies new tests and treatments and evaluates their effects on human health outcomes. People volunteer to take part in clinical trials to test medical interventions including drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioural treatments and preventive care. Four(4) Phases of a Clinical Trial Research Paper.
Clinical trials are carefully designed, reviewed and completed, and need to be approved before they can start. People of all ages can take part in clinical trials, including children.
There are 4 phases of biomedical clinical trials:
A phase 4 clinical trial begins after a drug has been approved for use in the general population following phase 1, 2 and 3 trials to rigorously test its efficacy and safety.
In phase 1 clinical trials, the safety, tolerability and toxicity of the drug at different doses is tested in a small number of healthy volunteers. In phase 2, the drug’s efficacy and optimal dosing regimen are established.
After phase 2, the drug enters the most vital stage of its development, the phase 3 trial. This is the last phase of testing the drug needs to complete before the drug information and clinical trial results are submitted to the regulatory authorities for approval of the drug for use in the general population.
The phase 4 trial is also referred to as post marketing surveillance and as the name suggests, it is conducted after the drug is already marketed and available to the general public. Four(4) Phases of a Clinical Trial Research Paper.The main objective of the phase 4 trial is to check the drug’s performance in real life scenarios, to study the long-term risks and benefits of using the drug and to discover any rare side effects.
In a phase 4 trial, any rare or long-term effects of the drug can be observed in a much larger population of patients and over a much longer period of time. If safety surveillance does indeed reveal concerns about the drug, it may be withdrawn from the market and no longer made available on prescription.
Other reasons for conducting a phase 4 trial include:
Previous clinical trials may have been limited somewhat in how thoroughly they could test the various different factors that could influence the drug’s performance. Four(4) Phases of a Clinical Trial Research Paper. For example, clinical trial patients may be instructed to follow a strict diet and drug regimen, while phase 4 trials are conducted on regular populations among whom a variety of different foods and other drugs may be ingested.
Untoward effects may have been missed in earlier trials and it is important for phase 4 results to be submitted to the regulatory authorities so that any rare side effects that may have been missed earlier can be noted.
Phase 4 trials are conducted in varied populations across multiple centres which eliminates bias or any unfair influence that could affect the results of the studies.
Many drugs have shown harmful effects only during phase 4 trials and have subsequently been banned from use. One example is the pain reliever rofecoxib which showed negative cardiac side effects during phase 4 trials and was therefore withdrawn from the market. Four(4) Phases of a Clinical Trial Research Paper.