Clinical Trials as a Treatment Option

When you’re dealing with a major health issue or condition, it’s helpful to know that in addition to standard treatment, complementary or alternative medicine, clinical trials may provide another treatment option. Clinical trials are research conducted on people in which new (and in some cases existing) treatments are evaluated for their effectiveness and safety. The people who participate in clinical research are volunteers.

Reasons for participating in clinical trials

The reasons people choose to participate in clinical trials are as varied as the individuals themselves. Some of the common reasons people decide clinical trials are right for them include:

• Access to the latest treatment before it’s available to the public
• Access to treatment otherwise unavailable due to cost
• Being a part of the evolution of treatment for a particular condition
• A new or different treatment option than what’s already been tried¹

The importance of volunteers

The clinical trial process is long and expensive, and it takes many years for a product to go through all the necessary steps to become an approved treatment. Some potential treatments fail to show effectiveness or have safety concerns and don’t pass all the requirements. However, many trials fail because they do not have enough participants. Regulatory agencies, like the U.S. Food and Drug Administration (FDA), require large groups of participants in trials to ensure the safety and effectiveness of therapies before they are available in market. It is estimated that 80-85% of clinical trials are delayed due to challenges finding and enrolling participants, and about 30% of trials fail because they can’t recruit any participants.²

Volunteering for a clinical trial

Each clinical trial has specific criteria that volunteers must meet to be able to participate, so not all people with the same condition will be eligible for the same trial. Some of the criteria is based on the disease or previous treatments, and other criteria relates to the individual, such as age, gender, and any other medical conditions.³

Are clinical trials only a last-resort option?

Sometimes, clinical trials are an option for people who have tried other therapies that have not helped their disease. However, there are other research trials that need volunteers who haven’t yet tried any treatment for their condition (called treatment naïve). For others, clinical trials can be an option when they can’t afford other treatments. Clinical trials can also be focused on finding the cause of a disease or evaluating the ways genetics may be involved in a particular condition.^1,3

Considerations before joining a clinical trial

Before taking part in a clinical trial, it’s important to understand your treatment options and essential facts about the particular trial you are eligible for. Each volunteer is provided with an informed consent form, which includes important information about the trial, including its purpose, how long it is expected to last, any tests or procedures that are expected, and potential benefits and risks (like side effects). In addition, you should talk to your doctor about your concerns and questions, including all your options, the benefits and risks associated with each, and costs involved.³