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A Comprehensive Guide to Clinical Trials

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In a clinical trial, the participants are bound to receive specific interventions as per the research plan or the protocols that have been made by the investigators. These interventions are medical products like drugs or may be a procedure or device to change the behaviors like diet or lifestyle. Clinical trials might also compare the medical approach to standard already available.

Who Conducts the Clinical Studies?

Every clinical trial and its study is carried out by principal investigator, who is also a medical doctor. It also includes a research team that includes the nurses, other doctors, social workers and other health care professionals.

Where Are These Clinical Studies Conducted?

Clinical studies are usually carried out at places like hospitals, doctor’s, universities, offices and community clinics. This location is usually dependent on who will conduct the study.

Reasons for Conducting Clinical Trials:

Usually, the clinical trials are designed to add a medical knowledge that is related to the treatment, prevention of diseases or conditions, diagnosis or others. Some of the most common reasons of conducting clinical studies including:

  1. Evaluate one or more interventions like medical devices, drugs, surgical approaches, radiation therapies etc in order to treat diseases, condition or syndrome.
  2. Finding potential ways to prevent the instance or recurrences of any diseases or condition. They include lifestyle changes, vaccines, medicines or others.
  3. Evaluation of one or more intervention aimed to identify and diagnose a particular disease or condition.
  4. Examining the methods of identification of a condition and the related risk factor for the particular condition.
  5. Measuring and exploring new ways to improve the quality and comfort of life through supportive care for people suffering from chronic illness.

What Are the Different Phases of a Clinical Trial?

Phase I Clinical Trial:

Under this phase, a new research treatment is given to a smaller number of participants and the safety is emphasized. The researchers here determine the best ways to give the new treatments and then try to find the drugs for serious side effect and what quantity is safe.

Phase II clinical trials:

Determination of the effects of the research treatment on that particular disease or the condition being evaluated is carried.

Phase III clinical trials:

Comparison of new treatments is made to the standard treatment and study different populations and different dosages and combinations of drugs.

Phase IV clinical trials:

Application of new treatment to the general patient care, after getting an FDA approval for market is done. For example, a new drug that has been found really effective in the clinical trial might be used together with other effective drugs to treat a particular disease or condition in a select group of patients.

Eligibility

The factors that allow someone to participate in clinical trials are called inclusion criteria and the corrollary is known as exclusion criteria. They are generally based on characteristics like age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.

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