Basics of Clinical Trials (A Complete Guide)
Clinical trial is one of the study designs of research. In a clinical trial, you check the safety or effectiveness of a medication, treatment, or surgical procedure. Note that clinical trials are not always related to medication. It is one of the strongest pieces of evidence. When an intervention or manipulation is involved, the study becomes a clinical trial. For example, when the researcher asks a person to do some exercises and looks at the after-effects, that is a clinical trial.
Clinical trials examine new ways to detect, prevent or treat diseases. They can study:
- New ways of performing surgery
- New ways to utilize existing treatments
- New medications
- New health care devices
- New ways to change the quality of life for patients with severe diseases
- New ways to change behaviors to improve health
The main aim of clinical trials is to check whether these behavior, treatment, and prevention are safe and effective. Anyone can participate in clinical trials to help researchers and doctors learn more about an illness and improve the population’s health care in the future. People with diseases also take part in clinical trials to possibly get the newest treatment and receive extra care from the clinal trial researchers. Clinical trials are at the center of all health care advances and offer hope to many people.
Clinical trial protocol
A clinical trial protocol is a plan made to balance the risks and benefits to participants and address specific study questions. It has the following information:
- Who can participate in a clinical trial?
- The aim of the clinical trial
- Protection against the risks
- The information that will be collected
- Information about tests, procedures, and treatments
- The period in which the trial is expected to take
There are two groups of participants: experimental group who receives a new treatment and the control group who receive the current standard treatment (it could be the best treatment or no treatment)
Clinical trial informed consent.
Informed consent gives participants key information about a study before they decide whether to take part or not. The process goes on throughout the research. The researchers explain the details of the study and provide informed consent with the details about the trial, including its goal, how long it’s expected to take, tests and procedures involved, and who to contact for details about the study. The participants can then decide whether to sign the document or not. Participating in a clinical trial is usually voluntary, and one can quit the study at any time.
Types of clinical trials
Treatment trials. Treatment trials test new drugs, a new combination of drugs, and new approaches to surgery or radiation therapy.
Prevention trials. These types look for better methods for preventing an illness in people who have never had the illness or to prevent the disease from reoccurring. Methods may include vaccines, medicines, or changes in lifestyle.
Behavioral trials. Behavioral trials check ways to improve behavioral changes meant to improve health.
Screening trials. This type of study tests new approaches for detecting diseases/health conditions
Diagnostic trials. Diagnostic trials compare procedures or tests for diagnosing a certain illness or condition.
Quality of life trials. These trials look for ways to improve the quality of life of people with diseases.
What is Randomization in Clinical Trials?
Randomization is when treatments are given to participants by chance rather than choice. Participants do not decide which treatment they want to receive. In most cases, researchers use a computer to assign volunteers the treatments. Randomization is done to avoid any bias.
What is blinding?
In blinded studies, participants do not know which group they belong to. This helps prevent the participants and members of the research from interfering with the outcomes. Blinding can be single or double. Participants are not told what they receive in single blinding trials, but the research members know. In double-blinding trials, neither the participant nor the research team knows what is given. Only the doctors know. This is done to avoid bias.
Phases of a clinical trial
1st phase. The research team tests a medication in a small group for the first time. The main aim is to determine the safety and side effects of the treatment.
2nd phase. More people are given the new drug to further learn about its safety and effectiveness.
3rd phase. In this phase, the treatment is given to large groups of people to confirm its effectiveness and monitor the side effects. Researchers also compare the new drug with similar treatments and gather the information that will allow the new treatment to be used safely.
4th phase. The drug is approved by the FDA and made available to the population at this stage.
Note that after the 1st and 2nd phases, the research team decides whether to continue with the study or stop if they find it unsafe or not effective. After completing phase 3, researchers evaluate the information and determine whether the results are important to health care. Clinical trial results are usually published in peer-reviewed journals, and some may be featured in the news.