Evidence-based clinical trial protocols are one of the most popular research methods in the medical sciences. If you look at the articles published by physicians, you will see that this research method was very practical and applied to other sciences such as the humanities and even Mathematics has also penetrated. Before getting acquainted with this protocol, we should know that the content of the clinical trial protocol can be divided into two categories:
1. Random evidence-based clinical trials that include studies that are randomly assigned.
۲. Non-random or non-experimental trials are not randomized in this trial but the procedure is such that non-randomness does not cause significant damage to the results.
Types of randomized evidence-based trials include:
- Diagnostic trial
- Prevention trials
- Early-detection trials / screening trials
- Genetic trials
- Quality-of-life studies / supportive) care studies)
- Treatment trials
In another definition, the types of schemes for clinical trial protocol optimization are as follows:
- Clinical trial without a control group
- Controlled clinical trial
- Evidence-based clinical trial
- Continuous clinical trial
- Preventive clinical trial
- Field trial
- Social trial
- Risk factor testing
- Random evidence-based clinical trial: In this study, samples were randomly divided into experimental and control groups. The purpose of this method is to evaluate the efficacy and effectiveness of a new intervention or drug and to help clarify the role of new drugs or interventions in clinical practice.
- Parallel concurrent scheme: In this case, a comparison is made between two randomly assigned groups. In this plan, one group is faced with a specific treatment and the other group is not faced with that treatment. Participants also remain in the study and control groups during the research period.
- Design successful: In this study, each group uses more than one treatment method. The most famous type of this method is the crossover design.
- Crossover plan: In this plan, all patients can be assured that they will receive new treatment during the review period. All patients should take the time to complete the study. In this method, it is not useful if the desired drug improves the disease and only works in a certain period of the disease. Also, this plan cannot be done for surgery, a new medication regimen, or a drug that completely improves patients.
- Factorial scheme: In this scheme, the researcher manipulates two or more variables simultaneously
- Preventive clinical trial: performed with the aim of primary prevention. Its purpose is to eliminate or prevent disease in a large population.
- Field trial: It is a kind of preventive trial. Samples are often non-sick or examined in a hospital or office or the community. This type of clinical trial protocol optimization can be done for vaccines, drugs, and prevention programs, except at the community level instead of in laboratories or health care providers.
- Social clinical trial: It is a kind of preventive trial and instead of studying each person individually, the study is done on groups in the community.
What is evidence-based clinical trial protocols?
How to develop a clinical trial protocol?
The main steps in creating a clinical trial protocol template are:
- Defining the study hypothesis: The most basic continuation in any research, whether field or non-field, is to determine the research hypotheses.
- Defining criteria eligible: Defining criteria is the second step in the process of creating and clinical trial protocol optimization.
- Patient selection: In clinical studies, most of which are evidence-based, the selection of the research community is highly effective in the result of the research.
- Random assignment of treatment/placebo or treatments to groups
- Decide on blindness
- Patient follow-up: Patients’ status Must be intelligently monitored.
- Evaluate therapeutic response and collect data
- Analysis of results: The results must be accurate, honest, and in line with human moral principles.
Therefore, to create and clinical trial protocol optimization, such a codified and systematic process must be followed. These steps must be followed carefully and coherently to achieve the best possible result.
