Clinical Trials Awareness Week: Clinical Trials 101

Clinical Trials Awareness Week is an annual occurrence that spotlights the importance of medical research. This year's focus is on enrollment and participation, which are absolutely crucial to ensuring that medical research advances. It's estimated that 80% of clinical trials are delayed or canceled due to a lack of enrollment, and these delays lead to the spending of unnecessary time and money to develop new drugs and treatments. 

Many of these delays can be attributed to individuals not knowing the facts about clinical trials and how participating in them can be beneficial. In this blog, we're sharing some key tips for individuals who might be considering enrolling in a research study — go through our "Clinical Trials 101" course below!

What is a clinical trial?

Clinical trials help researchers determine if investigational drugs or treatments are safe and effective. All investigational medications and devices must undergo clinical trials before they are made available to patients.

Who can participate in a clinical trial?

All clinical trials have strict guidelines about who can participate. “Inclusion criteria” are the characteristics that a person must have to participate in a clinical trial, and “exclusion criteria” are the characteristics that may prevent someone from participating. It is important for researchers to carefully follow these guidelines so they are able to answer the research questions and keep participants safe. 

Why should I participate in a clinical trial?

Participants will have access to new, investigational treatments that, if approved, will be available to the general public. They will also receive study-related medical care and attention from clinical trial staff at research facilities. Importantly, by participating in a trial, volunteers can help researchers find better treatments for future generations.

What should I consider before participating in a trial?

It's important to get as much information as possible about a clinical trial before officially enrolling. During the volunteer process, potential volunteers will have the opportunity to ask questions before agreeing to take part. Here are some questions that can be helpful:

• What is the purpose of the study?
• Who is going to be in the study?
• Why do researchers believe the new treatment being tested may be effective? Has it been tested before?
• What kinds of tests and treatments are involved?
• How do the possible risks, side effects, and benefits in the study compare with my current treatment?
• How might this trial affect my daily life?
• How long will the trial last?
• Will hospitalization be required?
• Who will pay for the treatment?
• Will I be reimbursed for other expenses?
• What type of long-term follow up care is part of this study?
• How will I know that the treatment is working? Will results of the trials be provided to me?
• Who will be in charge of my care?

What are the benefits and risks of clinical trials?

Before participating in a trial, participants will be asked to review and sign an informed consent form (ICF), which will explain the potential benefits, risks, and side effects that are possible while taking part in the study. Potential participants are also encouraged to discuss the benefits and risks with their doctors before making any decisions.

How will my safety be protected?

The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, clinical research is federally regulated and includes built-in safeguards to protect participants. Every trial has a carefully controlled protocol, which is a detailed plan the researchers will follow and provide updates on throughout the study. Researchers will also report what they learn at scientific meetings, to medical journals, and to various government agencies to showcase how the study is contributing to research.

What kind of preparation should I do for the meeting with the research coordinator or doctor?

Before meeting with the research coordinator, it's important to be prepared. It's advisable to plan ahead and write down any initial questions in order to get all the information possible. Additionally, it can be helpful to have a loved one come along for support and provide a second set of listening ears.

Can I leave a clinical trial after it has begun?

Yes. Even after signing the informed consent document, participants can withdraw from the study at any time and for any reason.

Can I continue to work with my doctor during a clinical trial?

Yes. Most clinical trials provide short-term treatments related to a designated illness or condition, but do not provide extended or complete primary health care. In addition, by having the doctor work with the research team, participants can ensure that other treatments will not conflict with the protocol.

Where can I find a clinical trial that’s right for me?

If you're interested in volunteering for a clinical trial, you can start by clicking the button below. Just enter your location and answer a few questions about your health and a list of trials that may be right for you will appear. You can then contact the trial coordinators through the site to get started.