The Four Phases in the Clinical Trails: A Short Notes

Corresponding Author:

Andrew Mac Department of Medicinal Sciences, University of Paris, France E-mail: andrew_m@up.fr

Abstract

Introduction

Clinical trials must always be allowed before they can commence, as they must be properly prepared, reviewed, and completed. Clinical trials are applicable to people of all ages, including children. Clinical trials go through four stages in order to evaluate a medication, determine the proper dosage, and examine for negative effects. If researchers find a medicine or other intervention to be safe and effective after the first three phases, the FDA approves it for clinical use and continues to evaluate its effects. The phases of drug trials are commonly used to characterise them. To evaluate if a medicine can be approved for use, the FDA normally requires Phase I, II, and III trials.

• A Phase I trial evaluates an experimental treatment on a small sample of healthy people (20 to 80) in order to determine its safety and adverse effects, as well as the proper drug dosage.

• In a Phase II experiment, more persons are involved (100 to 300). While safety is considered in Phase I, effectiveness is emphasised in Phase II. This phase tries to gather preliminary information on how well the medicine works in persons with a specific disease or condition. Safety, as well as short-term adverse effects, are still being studied in these trials. This stage can last for a long time.

• A Phase III trial acquires additional data on the drug’s safety and effectiveness by evaluating different populations and dosages, such as using it in conjunction with other medications. The number of participants normally ranges from a few hundred to around 3,000. If the FDA agrees that the trial results are positive, the experimental medication or gadget will be approved.

After the FDA has approved the use of a medicine or device, a Phase IV trial is conducted. The effectiveness and safety of a gadget or medicine are evaluated in broad, diverse groups. The side effects of a drug may not become apparent until it has been used by a larger number of people for a longer period of time. Study workers describe the trial in detail and collect more information about during a trial. After signign in an informed consent form when all of the questions have been answered to the participant and then he/she will accept to participate. They will be screened to ensure that you are eligible for the trial. If they are accepted into the study, will be scheduled for a first visit (also known as a “baseline” visit). During this visit, the researchers conduct cognitive and/or physical testing. A treatment or control group is allocated to you at random. The participant and his/her family members follow the study instructions and notify the researchers if there are any problems or concerns. Later on they are welcome to come to the research location on a regular basis for new cognitive, physical, or other examinations and conversations with the researchers.

Following the completion of a clinical trial or study, researchers will collect and analyse the data to determine what further steps are required in light of the findings. Before the study begins, participants will be given information about how long it will last, whether they are willing to continue getting study treatment after the trial finishes, if relevant, and how they will be kept updated about the study’s outcomes.

Acknowledgement

None

Conflicts of Interest

The authors declare no conflict of interest.