Understanding the Importance of Clinical Trials

What are clinical trials?


Clinical trials are studies that get conducted aiming at evaluating a medicine, surgical procedure, or behavioural intervention. They are the primary way that researchers find out if a new treatment, like a new drug, vaccine, diet, or medical device is safe and effective in people.

Clinical trials are often used for learning if a new treatment is more effective and/or has fewer side-effects.

What are the phases of clinical trials?

Four phases of clinical trials are:

The United States Food and Drug Authority (FDA) standards for clinical trials are considered as the benchmark of clinical trials all over the world. The US FDA typically requires very strict protocols to be followed while conducting a clinical trial.

The different phases of a clinical trial are as follows:

Phase I trial: In this phase of a clinical trial, the experimental drug or vaccine is administered to a small group of healthy people (20 to 80). This step is taken to assess the safety and any side-effects related to the drug or vaccine.

Phase II trial: In this phase, more people (100 to 300) are involved in the trial, and more emphasis is given to effectiveness. This phase can last for several years.

Phase III trial: In this phase, more information on the safety and effectiveness of the experimental drug is gathered. The number of subjects may range from 100 to 3000.

Phase IV trial: This is the last phase of the clinical trial. A device's or drug's effectiveness and safety are monitored in large and diverse populations. Sometimes, the side effects of a drug may not become clear until more people participate in the trials for a longer period.

Who can participate in a clinical trial?

Any individual can participate in clinical trials if they meet the criteria to participate in the trial. The screening may involve cognitive and physical tests.

Inclusion criteria for a clinical trial may include factors such as age, disease stage, sex, genetic profile, and family history.

Exclusion criteria include factors such as underlying health conditions or dependence on a particular medicine. These factors can interfere with the overall result of the trials.

How are clinical trials conducted?



Once people have been selected for the trials, the following steps are taken:

1) Induction into the clinical trials: The study staff and clinical research coordinators will explain the science behind the trial, along with additional information to the participants.

2) Consent from the participant: To ensure the authenticity of the clinical trials, a participant must be willingly participating in the trial, free from any bias or prejudices. The participants must sign a consent document that will ensure that the study results are consistent.

3) Screening: This step is taken to ensure that the participants meet the criteria of the research.

4) Acceptance: In this step, the accepted participants have to visit the research site at a pre-scheduled time. The researchers may conduct cognitive and physical tests during these visits.

5) Segregation: The participants are divided into two sections. One group is the test group, who will receive the experimental drug. The other group is called control, who is going to receive the placebo. The process of segregation is done discreetly and at random so that the trial results are consistent.

6) Visits: The participants have to visit the research facility regularly so that they could define all the vital information related to the drug for research purposes. This process continues till the end of the trials.

Conclusion

Clinical trials generate data on the safety and efficiency of a drug, vaccine, or medical technique. Approval from the health and ethics committee in the country is imperative to conduct clinical trials. 

The trials called for equal participation from the researchers and subjects for success. 

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