Learn the Types and Phases of Clinical Trials

Is the treatment safe in phase I clinical trials?

People are usually involved in the earliest phase of a new drug’s development. Phase I trials are conducted to determine the greatest dose of a new medication that can be administered safely without generating serious negative effects.

 

Although the medication has been evaluated in laboratory and animal trials, the negative effects in humans are unknown. These studies also aid in determining the optimum technique to administer the new therapy.

Phase I clinical trial highlights

• The first few participants in the research are given a very modest dose of the medication and are closely monitored. If the side effects are modest, the following few individuals are given a greater dose. This technique is repeated until doctors identify a dose that is most likely to work while causing an acceptable level of adverse effects.

• Phase I studies look at what the medicine does to the body as well as what the body does with the drug.

• The primary priority is safety. The research team maintains a careful check on the participants and looks out for any serious adverse effects. Due to the small number of participants in phase, I research, unusual side effects may not be observed until later stages of trials, when more people take the medication.

 

• While some patients may benefit from being on one, the primary goal of a phase I trial is not illness response.

• Placebos (inactive therapies) are not utilized in phase I trials.

• Phase I trials typically include a modest number of participants (up to a few dozen).

• Phase I trials often include people with various forms of cancer, and these studies are typically conducted in large cancer centers.

Phase I trials are the most dangerous. However, some patients benefit from phase I research.

For those suffering from life-threatening conditions, properly balancing the potential dangers and benefits is critical. When all other therapeutic options have been exhausted, people may choose to participate in phase I trials.