A clinical trial is a type of research or experiment in clinical research that evaluates a surgical, medical, or behavioral intervention. The study is people-based– for example, it can determine whether a certain vaccine or a new drug is effective and safe. Clinical researchers need to ensure the study results they get are accurate and applicable, so they often use a randomization method to ensure the study results from research are not biased and apply to the medical and scientific population. Here’s what to know about this process and what it means.
What is Randomization in a Clinical Study?
Randomization is the process where clinical researchers randomly select people to participate in clinical studies. Randomization can also mean the random application of the treatment tested. The method is based on chance whereby volunteers are assigned to study intervention. The scientific and medical population will regard a clinical study valid and useful when there is proper randomization.
How is Randomization in Clinical Trials Done?
The biostatisticians and investigators determine the randomization procedure. It should be detailed in the protocol and consider the following:
- Number of study sites
- Open trial versus the blinded trial
- Number of volunteers
- Single- or double-blinded
- The ratio of treatment allocation
- Stratification factors
- The treatment group number
Although participants are randomly selected, they should meet the required eligibility criteria. When it comes to random allocation, each participant is given a different level of treatment. One group, called the placebo group, does not receive treatment. This is helpful in determining the variations between the two groups.
The biostatistician should generate the method of implementation and randomization. The standard operating procedure should include:
- Variables used in the procedure
- A brief description of the randomization process
- The details of the generator of the randomization list
- Software and validation details used to generate the list
- Concealment allocation approach
- Personal information for people that will have access to the randomization list
When investigators are documenting the protocol, they should include the code-breaking procedures. These are situations where the participants can break the blinding of information. Example of these circumstances include:
- Adverse event of currencies
- Medical emergencies where the blending treatment information is required
For the participation process, the organization doing clinical research will do the following:
The phone interview is the first step where the recruiter asks you about general information, including your height, weight, contacts, and age. You will also fill in an application form before being added to the organization database.
2. Physical Screening
It’s mandatory to read and review the informed consent form and know more about the study before the process starts. Upon agreement of the terms and conditions, you’ll get a physical screening. After the confirmation of the screening, you will be ready to participate in the study.