Phase 1 Clinical Trials and How They’ve Changed

There are research studies for the testing of treatment on humans and phase 1 clinical trials are the second of five phases. They are intended to find out if a drug or procedure is safe for humans. But before going to phase 1, a drug must be tested extensively in the lab on disease cells.



There is a tremendous change in the role of phase 1 clinical trials in cancer due to the human genome project (HGP). The HGP was completed in 2003, which allowed scientists to discover the sequence of human genes. This gave way for the advancement in the diagnosis and treatment of many illnesses, including cancer.

Before HGP was formulated, clinical trials for new experimental drugs only have a small chance to benefit a person because they were often on a last-ditch effort. However, the excellent option to extend life is to participate in the phase 1 clinical trial.


Purpose of Phase 1 Clinical Trials

In order to determine if an experimental drug or treatment is safe, there is a need to undergo phase 1 clinical trials. After testing the treatment in the laboratory or on animals, it will enter a phase one lab to conduct tests on humans.


  • Characteristics

It involves only a small number of people to check if a treatment or drug is safe. This will also determine the best dose and how it must be given.


  • Monitoring

This is the first study to be tested on humans and so it carries the greatest risks. Those enrolled in the study are monitored closely wherein blood and urine are collected regularly.


Changes In Phase 1 Clinical Trials

In the past few years, there are changes in phase 1 clinical trials. The advancement in precision medicine has allowed treatment to account for individual genetic differences. So it is likely that phase 1 clinical trials will go further to offer more promise for individuals and not just to see if the drug is safe.

Targeted cancer therapy can help in making a difference for your disease, as it targets specific cell abnormalities and varies from standard chemotherapy. One example is on a targeted therapy Vitrakvi having a successful clinical trial in which the FDA has granted accelerated approval in 2018.


Why Consider Phase 1 Clinical Trial

One of the reasons why someone would consider participating in a phase one lab is the hope of improving medicine to help others in the future with the same disease.

Another reason is the hope that a new medicine or procedure that has yet to be tested on humans will offer better chances of survival when there are failures in other treatments.



There are many ways to look at phase one lab. On one end, they may be risky to consider. However, on the other end, the benefits may outweigh the risks involved in the phase 1 clinical trial.

In fact, a new experimental drug may help more than anything else available in the market, instead of looking at the same procedures to compare drugs already been tested only to give cancer patients hope of survival for a few months.


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