For Clinical Trials Awareness Week: Clinical Trials 101

It’s Clinical Trials Awareness Week! This year’s focus is on enrollment and participation, which are absolutely crucial to ensuring that medical research advances. Did you know 85% of trials are delayed or cancelled because researchers can’t find enough patients to take part? These delays make it take longer and cost more than it should to develop new drugs and treatments.

Read on to learn more about trials and how you can get involved by visiting www.trialreach.com.

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. “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 questions they are studying and so they can keep participants safe.

Why should I participate in a clinical trial?

You will have access to new, investigational treatments that, if approved, will be available to the general public. You will also receive study-related medical care and attention from clinical trial staff at research facilities. And, importantly, by participating in a trial you can help researchers find better treatments — and maybe cures.

What should I consider before participating in a trial?

You should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions. The following questions might be helpful to discuss with the health care team.

• 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 you can participate in any clinical trial, you will be asked to review and sign an informed consent form (ICF), which will explain the potential benefits, risks, and side effects that you may experience while taking part in the clinical trial. The investigational treatment may or may not help to make your condition better. While you may have a positive trial experience, you may also experience unpleasant or serious side effects. It’s important to discuss the benefits and risks with your doctor 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 with built-in safeguards to protect participants. Every trial has a carefully controlled protocol, which is a detailed plan the researchers will follow. As a clinical trial progresses, researchers provide regular reports to review boards. These review boards make sure the researchers are following the study plan and all ethical and legal codes. Throughout the trial, the researchers will also report what they learn at scientific meetings, to medical journals, and to various government agencies. Participant names will remain confidential and will not be mentioned in these reports.

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

• Plan ahead and write down your questions.
• Ask a friend or relative to come along for support and to hear the responses to the questions.
• Record the discussion to replay later.

Can I leave a clinical trial after it has begun?

Yes. You can leave a clinical trial at any time. When withdrawing from the trial, you should let the research team know and share the reasons for leaving the study.

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, the participant can ensure that other treatments will not conflict with the protocol.

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

You can visit www.trialreach.com to be matched to clinical trials in your area. 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.

Content courtesy of our partner, CISCRP.

Originally published at blog.trialreach.com on May 3, 2016.