Are Clinical Trials Safe?

Are Clinical Trials Safe

Clinical trials are an important part of bringing pharmaceutical drugs and other interventions to the public for use as approved medical treatments. They help to show whether a treatment method is safe and effective. But you might be wondering about clinical trials safety during the research process and whether you would be putting your health and safety at risk if you participated in a trial.

The answer is that clinical trials come with some risks. Yet they also follow stringent safety guidelines and have measures in place to ensure safety as much as possible. Let's take a deeper look at the answer to whether clinical trials are safe.

Clinical Trial Risks

On the one hand, clinical trials do come with risks to your health and safety. What's important is to consider those risks and weigh them out in regard to potential benefits. The American Cancer Society points out that you face risks from anything in the medical field, whether it is a treatment, a test or a procedure. Clinical trials are similar in that they also have risks while potentially providing some benefit.

Yet it's true that trials may have a higher risk compared to the other aspects of the medical field. That's because the safety of treatments and testing is determined through the trials. Trials come at an earlier stage when safety hasn't fully been established. This leaves room for uncertainty and the possibility of risks, which could include:

  • Side effects from an intervention, which could potentially be serious
  • Ineffective or less effective treatment
  • Difficulties from being in the trial, such as extra traveling, lost work time, or hospital stays
  • Being in the control group and not receiving the treatment (the experimental group receives the new treatment and the results are compared to the control group, which receives the current standard treatment or no treatment often in placebo form).

Phase I and II clinical trials come with higher risk because they are earlier stages of testing. At this point, you are among small numbers of people being studied, and research may not yet have found potential side effects and risks of the intervention being studied.

You might decide that some risk is worth the potential of improving medical options for yourself or others. For example, someone with cancer or another disease, especially a life-threatening one, may be willing to accept risks if a new treatment has the potential to help their symptoms or extend their life. This may especially be the case if current options are ineffective or lacking for a person's situation and a new option shows promise or gives hope.

Clinical Trials Safety Measures

While clinical trials do come with risk, there are protections in place to ensure the safety of trial participants as much as possible. To start with, trials do not occur or do not advance to the next stage if they are not deemed reasonably safe. Clinical trials do not begin until after preclinical testing has already occurred. Research may have been performed on animals or human tissue, for example.

Also, the U.S. Food and Drug Administration (FDA) and an institutional review board (IRB) review an application for the trial. The IRB needs to approve of the method of the trials before researchers can move forward with human participants. At that point, there are different phases of a clinical trial. Trials start with small numbers of people to focus on specific goals, such as how a drug affects the body. Researchers will not move forward to the next phase if there are certain risks, such as unacceptable toxicity of a drug.

Laws are in place to protect participants of clinical trials. The National Institute on Aging shares measures that have been put in place to ensure clinical trials safety, which include:

  • An informed consent process that takes place before agreeing to participate, which provides information to each person about what to expect and possibilities of the trial, and gives the opportunity to ask questions
  • The requirement that every clinical researcher monitors every participant and ensures their safety
  • Rules enforced by the Federal Government that researchers must follow
  • An approved plan for each trial that the researchers must follow, which is overseen by a head researcher
  • Supervision by a Data and Safety Monitoring Committee to review results as the study is ongoing and intervene if necessary

While there is some risk to participating in a clinical trial, there are laws and procedures in place that help to ensure the safety of participants. People are given the choice of whether to participate, and they often decide that potential benefits are worth some level of risk. Benefits could include the development of more effective testing and treatment methods than current standards, access to new treatments not yet available to the public, and better health care, among others. Ultimately, anyone who is considering whether to participate in a clinical trial and is not comfortable with the risk is free to say no. Only those who agree to give their informed consent participate in a clinical trial.

Participate in a Clinical Trial with ClinicalConnection

ClinicalConnection helps connect members to clinical trials in their area that strive to maintain the highest safety standards. Each clinical trial available through ClinicalConnection has been reviewed by an Institutional Review Board (IRB) or other oversight agency to ensure that the risks are minimized. If you are interested in participating in a clinical trial, create a free membership with ClinicalConnection.com to be notified of new trials in your area.