When you have a health condition or illness that isn’t responding to conventional medications, participating in a clinical trial can help you access new treatment approaches that aren’t yet available to the general public. Your participation can also make a valuable contribution to the medical field since it can help researchers better understand different treatment protocols. But before you rush to take part in a clinical trial, it’s important to weigh the risks and the benefits.

What Are Clinical Trials?

Clinical trials are research studies that are designed to test new medicines, devices, or surgical procedures on humans in order to determine their safety and effectiveness, explains John Reites, Sr. Director at Quintiles Health Engagement & Communications, which helps healthcare companies develop and commercialize medications. There are different types of clinical trials, including those that explore preventive approaches to avoid diseases, as well as ones that look at the effectiveness of different types of treatment strategies, Reites points out.

Clinical Trial Phases

Most clinical trials are divided into different phases, with each phase designed to collect specific kinds of information about the study drug or regimen, according to Reites:

  • Phase I clinical trials put new investigational drugs or strategies to use in people (usually a small group) for the first time. These trials are designed to determine dosage, safety, and side effects.
  • Phase II clinical trials test the new drug or protocol in a larger pool of participants to measure its effectiveness and reinforce the findings of Phase I studies.
  • Phase III clinical trials broaden the research to include a much wider base of participants. At this stage, the medication or concept being studied is often compared to a placebo. The results of this phase can provide important information and help the drug gain approval. Once a drug has been approved (by the Food and Drug Administration, or FDA, in the US), it can be made available to the general public.
  • Phase IV clinical trials take place after the drug has been formally approved and is available in the marketplace. During this phase, researchers are interested in identifying any side effects that weren’t found earlier.

What to Expect When Participating in a Clinical Trial

From a practical standpoint, most clinical trials will involve visiting your doctor and answering lots of questions. You will likely be given some type of medication or treatment protocol to follow, and then you will be studied over an extended period of time so researchers can determine the treatment’s effectiveness. Some clinical trials also require you to keep a log at home to track your symptoms and identify patterns.

Throughout the clinical trial process, which can last anywhere from a few months to several years or more, you can also expect to receive ongoing medical care and testing, usually at no charge. Some clinical trials also offer financial compensation to participants.

Weighing the Risks of Clinical Trials

While taking part in a clinical trial can allow you to try investigational drugs that may help you feel better, you also need to consider the risks. For instance, researchers may not yet have a complete understanding of the side effects of the medication being studied, so there’s no way to fully assess the treatment’s safety in advance. In addition, there’s no guarantee that the treatment will work for you. Finally, in later phase studies there’s always the chance that you won’t be given the real medication but instead will get a placebo. You’ll need to weigh these issues carefully when deciding whether a clinical trial is a good fit for your particular situation.

Finding a Clinical Trial

If you’re interested in learning more about clinical trials, talk to your doctor and ask for suggestions. You can also visit a registry of clinical trials such as www.clinicaltrials.gov or www.clinicalresearch.com to view a list of upcoming opportunities. Just keep in mind that most studies have very specific participation requirements, so it may take some time to find one suited to you.

John Reites reviewed this article.

Sources

John Reites, Sr. Director, Quintiles Health Engagement & Communications. Email interview, March 28, 2014.