The Clinical Trial Process: An Overview

Clinical trials are the safest means of supplying new medicines and treatments into the health system. Scientists and volunteers alike aim to advance our understanding of human health through clinical trials.

These trials are conducted in three to five phases or steps, each with a purpose. Before continuing, each phase relies on the supporting research of the previous phase. A trial can’t start without final approval from a credible scientific regulatory body. 

If a trial is unsuccessful at any stage, the process could be discontinued or delayed until further research. Every clinical trial is done under a preset of moral and ethical principles and only involves consenting volunteers.

If you’re participating in a clinical trial or are a researcher planning to carry out a trial on your own, it would be beneficial to know what to expect to demystify the process. 

The following are what you need to know about the clinical trial process:  

Small Sample Group 

The first phase of clinical trials begins with a preclinical process. This is where scientists research, study, and develop new ideas to validate the purpose of a clinical trial being performed.

Getting a clinical trial proposal approved requires the trial runners to present their data in a set format. This can be done using the ryze visual define XML editor to help you submit clinical trials data and sustain data management. 

If the research is promising and gets enough backing, then it can move on to the investigating group searching for volunteers. The group of volunteers has to meet specific criteria set by the trial runners to be selected. This ensures the trials are carried out using the same variables

At this stage, the sample size is kept to a small group ranging from about 10–15 people, especially if it’s a clinical trial on a new medicine. As a safety protocol, starting with a few people allows researchers to test the safety and effect on people while minimizing potential harm.  

Determining Dosages and Effectiveness 

Once the first stage of the trial is successful and the drug or treatment is deemed safe, investigators can move on to the second phase. This phase involves testing the medicine to find a suitable dosage, or testing the treatment and then evaluating the effect it has on the sample group.  

The second phase of the trial takes the longest time, as most often it can last for years or decades. This is because researchers need to test how the medicine or treatment affects the health of the volunteers over time and how much is needed to create any changes. Too-early approvals even during emergencies can have an unpredictable impact on human health.   

A successful result is when the medicine or treatment shows improved long-term effects on the volunteers at the current dosage. An unfavorable outcome would be the medicine or treatment not having any effect on the health of volunteers or worsening their condition. If this happens, then the trial could be discontinued or halted until further research is done 

Enlarging Sample Group 

If the second phase of the trial proves to be promising after a few years, then researchers move on to the third phase. This stage is where the drug or treatment is given to a larger group. It can be from a few thousand people to tens of thousands as a sample size. The larger group also needs to meet the specific criteria of the small sample group to participate. 

The researchers will now study this larger group taking the medicine or undergoing trial treatments in detail and continue collecting their information over the years. Useful data needed in the future if the medicine or treatment is to be approved are also gathered at this stage.

The data can be: 

■ Side effects of the medicine 

■ Conditions under which the medicine can’t be taken 

■ The recommended safety of the medicine for children, adults, and pregnant women

■ Deciding if the medicine should be over-the-counter or prescribed 

Using a larger sample group makes testing more accurate and credible, which helps build a case for the medicine or get approval for the treatment later on. This stage will then conclude once the researchers are satisfied with their results and timeline, and are ready to present their data to the United States Food and Drug Administration (FDA) to get the medicine or treatment to the public. 

Conclusion 

Clinical trials are conducted to test the development and effectiveness of new medicines. They’re also used to support hypotheses about human behavior, psychology, and biomedical health. The trials use volunteers who meet the conditions of the research and criteria. 

The investigators must prove the success of their trial at each stage before moving on to the next stage. They also have to monitor the volunteers and continuously gather all data and evidence on their trial. 

All of these aim to get approval from the FDA so the medicine or treatment can be safe for public use. This is to improve existing health systems and to find better treatments for human illnesses. 

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