A clinical trial is defined by the World Health Organization as “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions.” The goal is to evaluate the effects and outcomes of a trial on health.
There are several interventions used in a clinical trial. Apart from drugs, cells and other biological products, radiological procedures, surgical procedures, behavioral treatments, preventive care, and other devices are used as interventions.
There are several phases in a clinical trial, with each one performed for a specific goal before moving to the next phase. There are pros and cons for each phase as well.
This article will focus mainly on Phase I clinical trials and the many aspects involved in it.
What are Phase I Clinical Trials?
This is performed to see if a treatment or experimental drug is safe. The drug or treatment is first tested in the lab or on animals before they are used in human subjects during a Phase I clinical trial.
In a drug development process, Phase I usually involves testing experimental or new drugs on healthy volunteers. Usually, 20 to 100 normal healthy volunteers are invited to participate.
The goal is to evaluate the drug’s safety when administered on specific doses. The doses are often sub-therapeutic or increased as a test progresses.
The volunteers are monitored by a clinical researcher, with a specific role to determine the safety and efficacy of an experimental drug.
The success rate of a Phase I clinical trial is approximately 70%.
Changes in Phase I Clinical Trials
In the last decade, Phase I clinical trials have gone through major changes. This is especially true for drugs targeting cancer.
These new drugs have been carefully designed to inhibit a specific pathway in the growth of cancer. For instance, it targets a precise pathway that a cancer cell must go through to divide, grow, and spread.
Based on this design, the experimental drugs have a more reasonable chance to make a difference. They can better hold cancer in check for some time. Also, they are often less likely to have major side effects compared to traditional chemotherapy drugs.
The targeted drugs may also help immunotherapy drugs to have a durable response. Even for just a small percent of people, the change can make a huge difference.
With the advancement of precision medicine, Phase I clinical trials may no longer be just a phase performed to check the efficacy and safety of a drug.
Considerations for Participation
Before you decide to participate in a clinical study, there are certain considerations that you have to make.
Some of the questions you need to ask are:
- What is being studied?
- What are the possible interventions that you may receive during the trial?
- What are the benefits, possible risks, and side effects of the intervention used?
- What procedures and tests are involved?
- Does the trial require hospitalization?
- How long will the Phase I clinical trial last?
- If I am injured during the study, what are my options?
With the changes in Phase I clinical trials, there are more facts than myths and fiction surrounding it. You can safely say that participating in one is highly beneficial these days.
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