Stages Of Clinical Research

Stages Of Clinical Research

Health or medical problems are inseparable from the problem of drugs and their use in humans. Therefore, health research also includes research on drug use. Drugs, in addition to being useful for healing diseases, also have various negative effects on human life, even the wrong use of drugs can cause death in humans.

For this reason, before the drug is marketed, it must first be evaluated through research. The effort to develop and evaluate this drug must go through various stages of research, which are generally divided into three stages, namely: a) preclinical pharmacological research; b) pharmaceutical research; and c) clinical research. Preclinical pharmacology and pharmaceutical research are research, and drug experiments on experimental animals, while clinical research (clinical Trial) is the study of drug experiments on humans. In this chapter, only the third phase of research (clinical research) will be discussed.

The purpose of clinical research is to test the effectiveness of the drug in humans. Itself, before the drug is tested on humans, it must first be tested on experimental animals. 

Based on its purpose, this clinical research is divided into four stages, namely:

1. First Stage

The first phase of clinical research is the administration of drugs for the first time in humans after the drug in question has escaped pharmacological and toxicological research in experimental animals. The aim of this phase of clinical research is to demonstrate the clinical pharmacological effects of a drug in a small group of patients or volunteers. The measurement in this study concerns the efficacy of drugs, with the data collected, are: type of drug, the relationship between dose and response, duration of drug action at a single dose, metabolism, and interaction.

2. Second Stage

The purpose of the study at this stage is to determine whether the pharmacological action that has been proven in the first stage is useful for treatment. The indicator of the research measurement of this stage is the cure of the disease. But because the cure usually occurs in a long time, the pharmacological effects are used as indicators, such as blood sugar levels, decreased blood pressure, and so on. In addition, it is necessary to collect data on side effects sufficient to early estimate the ratio between risk and profit. From the research at this stage can be determined the benefits of the drug in question compared to other drugs or treatment methods that already exist. In this stage can also be determined the relationship between the dose and levels of drugs in plasma or tissue with clinical effects.

3. Third Stage

At this stage, more trials or patients are needed and carried out outside the second stage of research, and the results of this study can strengthen or reject the things found in the second stage of research, for example, the incidence of low-frequency side effects, the profile of the drug in question when used in patients who are not carefully selected, and so on.

4. Fourth Stage

This stage is the research that is carried out after the drug is marketed. Therefore, this study is often called post-marketing drug surveillance, the purpose of which is to overcome the lack of information that existed in the previous stage of research. This study covers four main issues, namely:

  1. Side effects, especially those that appear as a result of short-term use of the drug.
  2. The issue of benefits, which includes the effect of the drug on long-term administration in the effort to prevent relapse, complications of the disease, 
  3. and the benefits of drugs compared to other ways of healing.
  4. Usage Data, which include drug use for new indications, overuse, misused, and abuse, are typically difficult to find in controlled clinical trials.
  5. The ratio of cost or risk/profit, danger, and cost.

At this stage, the research methods used are not only clinical research but are used in epidemiological research, surveys, and monitoring. At this time clinical trials as a method of Health / Medical Research use is not only limited to the development and evaluation of drugs, but began to be used for the development and evaluation of other ways of healing, for example, surgery, physiotherapy, types and ways of treatment, and so on. All these activities are usually called health care research (health care trial).

Source

Notoatmodjo, S. (2010). Notoatmodjo s Health Research Methodology, editor. Jakarta: PT. Rineka Cipta.

Creswell, J.W., & Miller, D. (2000). Determining validity in qualita¬tive inquiry. Theory into Practice, 39(3), 124-130.

Bowling, A. (2014). Research methods in health: investigating health and health services. McGraw-hill Education (UK).

Creswell, J. W., & Creswell, J. D. (2017). Research design: Qualitative, quantitative, and mixed methods approach. Sage publications.

Creswell, J.W. & Piano Clark, V.L. (2007). Designing and Conducting Mixed Methods Research. Thousand Oaks, CA: Sage.

Green, J., & Thorogood, N. (2018). Qualitative methods for health research. sage.


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