Clinical Trial Phases and Clinical Trial Safety

One of the biggest questions potential clinical trial participants ask is “Are clinical trials safe?” Along with clinical trial safety, they also have questions about clinical trial phases. The two words that are always top of mind for clinical trial researchers are “safe” and “effective.”

1. Is this clinical trial process they are going to perform on people or a new drug they are giving them going to work to improve their health, and
2. Is it going to do so without causing an unreasonable amount of further harm?

While safety has always been the top priority when it comes to any kind of medical treatment, clinical trials differ in that they are exploring uncharted waters.
No medical treatment is without risk. That is why any trial studying people is conducted in four carefully supervised phases, with each phase building upon the previous, as well as ensuring informed consent for the participant prior to volunteering. The main question to consider before one volunteers is: Do the possible benefits of the clinical trial outweigh the potential risks?

What Are the Possible Risks and Benefits?

Benefits:

• Having access to a new treatment not yet available to others
• Being closely monitored every step of the way by a research team
• Being one of the first to benefit if the treatment shows to be more effective than current standard treatments
• Helping scientists learn more about diseases so that they can help people in the future

Risks:

• A new treatment may not be more beneficial than a current/standard treatment
• Depending on the trial, you may be given a placebo
• Uncomfortable and time-consuming testing may be involved
• Substantial travel and doctor visits during the trial may be necessary
• The new treatment may work great for some and not for others
• Health insurance may not cover the costs for the patient involved in a trial

Why Do People Participate in Clinical Trials?

People who volunteer for clinical trials do so for various reasons, and not every volunteer even has a disease. Healthy individuals may volunteer because they wish to help others by contributing to the advancement of scientific study. Other people with illnesses take part also with the hope of helping others, but with the added potential benefit of receiving the newest treatment that could help their condition.

Phases of Clinical Trials

According to the American Cancer Society, each clinical trial undergoes a series of phases, with each phase building on the other and each designed to answer specific questions. These phases (I-IV) record specific information. Depending on the results, the clinical trial may be halted temporarily or even terminated if data shows the treatment to be unsafe or ineffective:

• Phase I: These trials test an experimental treatment on a small group of participants, often containing healthy individuals in order to determine overall safety, side effects, and dosages. It is said that “Phase I studies are done to find the highest dose of the new treatment that can be given safely without causing severe side effects.”
• Phase II: Lasting up to several years, this next phase increases the trial sample size based on phase I safety approval and emphasizes treatment effectiveness on people who have a certain disease or illness. It is still critical to monitor safety and side effects of the new drug.
• Phase III: This phase amplifies the process by studying different populations and different doses, while also using the new drug alongside other drugs to monitor compatibility. If all goes well, the FDA will approve the experimental drug or treatment.
• Phase IV: After being approved by the FDA, the experimental medication or device’s effectiveness may be monitored in large and diverse populations. Often, certain side effects may not become clear until more individuals have used it over a greater period of time.

If at any point during any of the four phases the studies show that the experiment is either unsafe or ineffective, the clinical trial will be disbanded and will cease further research immediately.

Ensuring Clinical Trial Safety

It is for these above reasons that many protocols have been put into place when it comes to the approval of new clinical trial studies. For example, an application or request for an investigational new drug (IND) must be filed with the FDA before researchers can conduct their studies of a new drug/treatment in humans. It is up to the FDA to approve the study’s safety before any clinical trial on a human can take place.

The IND application contains certain information that is required for the FDA to review, including:

• Results from studies prior to human testing for the FDA to evaluate and decide if the treatment is safe for testing on people
• How the new drug is manufactured, including…
  • Who made it
  • All the ingredients contained
  • The stability of it
  • Etc.
• Thorough outlines explaining the planned clinical trial for protocol review (in order to avoid needless risks)
• Clinical trial team information to make sure that they have all the knowledge, skills, and resources to run the clinical trial safely

In addition, research sponsors are required to give informed consent to all participants. The study must also be reviewed by an institutional review board (IRB) to ensure the trial is a moral one. They also agree to fully follow all the rules established for the study of new investigational drugs and treatments. Clinical trial research has these protocols in place in order to maintain the necessary standards for safety across the board.

—

Back to The Guide

Back to Home Page