What is a clinical trial study?
Clinical trials are new drug or procedural treatments that are experimentally applied to human subjects. The ultimate goal of clinical trial research is to determine whether a new treatment is effective and safe for users.
Any new drug or medical procedure that reaches the consumer will go through a rigorous enough testing process to be approved for general use.
In order to ensure that clinical trial research can progress as desired, one of the key issues is the research protocol. The study protocol will be discussed by a variety of research stakeholders to protect the health of the participants and answer the following specific research questions:
- Who is eligible to participate in the trial?
- What is the length of the study and what information will be collected?
- What is the objective, design, approach, statistical considerations and organization of the test?
Usually a clinical trial is led by a principal investigator (PI), usually a doctor. Along with that, the team of researchers regularly monitors the health of each participant to determine the safety and effectiveness of the study.
Benefits of clinical trials
Clinical trial research is considered as the foundation of health in general as well as medicine in particular. Therefore, it brings many specific benefits to patients.
Most people who come to clinical trials are people with a group of serious diseases that have not yet found a cure. Finding new research will help those people get a new treatment before many others.
The second benefit of the clinical trial is that the patient will be more hopeful in the search for life, which in turn will also create a positive attitude in the patient's own self-care.
Next, because clinical trial research is in the process of research and testing, any changes in the pathological process will be continuously updated by the team of researchers and doctors so that the process can be improved. treatment is most effective for the patient.
Finally, with the decision of volunteers to participate in the pilot study, it will help the process of finding ways to treat groups of serious diseases better in the future. This is an opportunity, a humanity, meaning in life for researchers and clinical trial participants.
What are the potential risks of a clinical trial?
There are two sides to any problem, and even with clinical trials, there are benefits but also potential risks for volunteers.
As mentioned above, clinical trial research is the application of new treatment modalities to test subjects, which here are humans. Therefore, although a system has been developed to prevent possible incidents with volunteers, the risks are not known in the first place.
The use of new treatments can cause serious or uncomfortable side effects for volunteers such as pain, nausea, hair loss, etc. However, because it has not been applied in practice, it may not be as effective or as effective as the old treatment methods.
Finally, with some clinical trials, it may be located far away from where the volunteers live. For volunteers to be able to participate, it will be necessary to alternate between the research site and the hospital, which will cause time and potential risks during the volunteer's movement.
Why is it important to limit the risk for volunteers participating in the research?
Given the benefits and risks of an experimental study, the question of why it's important to limit the risk for research-engaging volunteers is certainly answered.
When we can well control the right implementation of the research procedure by the research team along with the expected adverse events that the subject may have, the risk to volunteers who participate in research will be greatly reduced.
When done, risk reduction will also help to increase the reputation of clinical trials in general in society. Since then, more and more new experimental research projects will be conducted, bringing new rays of hope to humanity in the treatment of serious diseases.
VIETSTAR BIOMEDICAL RESEARCH is a Contract Research Organization (CRO) of a scale that fits the needs of clinical trial research projects. With the mission of "Bringing the miracle of science to patients around the world", VietStar Biomedical Research always takes the customer as the center, along with the experience and professional working style will bring to projects Successful research with excellent cost effectiveness.
For more details about us, please refer to the address as below:
VIETSTAR BIOMEDICAL RESEARCH
Room 201, 2nd Floor, N01T1 Tower Office Building, Diplomatic Complex, Bac Tu Liem District, Hanoi, Vietnam.
Tel/ Fax: + (84 24) 32 000 867 - Hotline: + 84 (0) 903 40 43 34 , + 84 (0) 989 18 88 07. Email: contact@vietstar-research.com.
Website: www.vietstar-research.com.