Q: What are clinical trials?

Ask Our Expert About Clinical Trials

About Our Expert

Sam Bub, M.D.
Family medicine physician

• What are clinical trials?
  
• Do you mean clinical trials aren’t just for drugs?
  
• Why are they important?
  
• Who conducts clinical trials?
  
• Are they a good option for me?
  
• What about side effects? How will I know if I am at risk for them?
  
• What are some things I should consider before joining a clinical trial?
  
• What’s the difference between Phase I, II, III and IV clinical trials?
  
• Will the researchers protect my confidential information?
  
• Does the U.S. government require clinical trials?
  
• How do I find a clinical trial that’s right for me?
  
• Does Lehigh Valley Hospital participate in clinical trials?
  
• How do I find out about enrolling in a trial?
  

Q: What are clinical trials?

A: Clinical trials are medical research studies that enlist volunteers to find out whether new medications, practices or devices are safe and effective. They are designed to find better ways to prevent or treat illness or disease.

Many clinical trials test a new drug against a placebo. A placebo looks just like the drug being tested, but it doesn’t contain active ingredients (it’s like a sugar pill). If it is a randomized trial, participants are randomly assigned to either the drug or the placebo. Most trials are double-blind, which means neither the doctor nor the participants know who will receive a placebo and who will receive the drug. This helps ensure that the results of the trial are accurate.

Q: Do you mean clinical trials aren’t just for drugs?

A: Right. In addition to drugs, clinical trials may test a medical device such as a heart pacemaker, a diagnostic tool such as a MRI, or a genetic test. Some trials even look at a new ways to prevent disease or provide support to people who are for sick. In some cases, clinical trials test different uses for existing medications or new therapeutic options for existing drugs, such as a once-a-week dose instead of a daily dose, or an inhaled medication instead of an injection.

Q: Why are they important?

A: Without clinical trials, advances in medicine would not be possible. Clinical trials have played a huge part in keeping us healthy and living longer. They are the best way to prove that new medications, practices or devices are safe and effective.

Q: Who conducts clinical trials?

A: Clinical trials get started when researchers develop new ideas for medical research. These researchers may work for private companies (such as drug manufacturers), medical centers (including hospitals and medical schools) or government agencies.

Q: Are they a good option for me?

A: They may be. If you are interested and see a reputable institution participating in a trial, find out more about it. In addition to receiving your medication for free, you can be assured that your doctor will be careful about monitoring you and reporting any unusual side effects. Often, patients will be reimbursed for travel time and may receive additional compensation. The public plays a huge role in the success of clinical trials, and in the long run the findings may benefit thousands of people.

Q: What about side effects? How will I know if I am at risk for them?

A: These trials are conducted very carefully. You are told about all possible side effects and must sign an 'informed consent' document before the trial begins. In Phase I and II studies (there are four phases, or parts, to a clinical trial), you also must meet specific criteria, which means that certain conditions must be met and you must not have certain medical conditions in order to participate.

You are given a phone number to call 24-hours-a-day, seven days a week to report any side effects. Your doctor is given guidelines on possible side effects and can always take you out of the study. Also, an independent review board monitors each clinical trial and is notified any time a participant reports side effects. This board also has the power to stop a study.

Q: What are some things I should consider before joining a clinical trial?

A: Not every study is the same. They can take three months or several years. When you are interviewed for a trial, listen carefully and think it over before signing the informed consent. Be sure that you are able to follow the instructions and rules of the trial.

Q: What’s the difference between Phase I, II, III and IV clinical trials?

A: The U.S. Food and Drug Administration (FDA) groups clinical trials into four phases:

• Phase I: First, researchers test a new drug or device in about 20 to 100 healthy volunteers to determine whether it is safe and what side effects it may have.
  
• Phase II: Next, researchers test the new drug or device in about 100 to 300 people to determine whether or not it works and to learn more about possible side effects. So Phase II studies address safety and effectiveness.
  
• Phase III: Researchers compare the new intervention to current standard therapy to learn whether it offers any advantage. In a Phase III study, several hundred to several thousand people receive the new drug or device. The FDA will only approve drugs that complete Phase III testing.
  
• Phase IV: This phase happens after the drug is approved. It monitors long-term side effects, effectiveness and other potential uses.
  

Q: Will the researchers protect my confidential information?

A: Yes. During the informed consent process, researchers should tell you how your information will be handled. Clinical trials may differ in how they protect your confidentiality, but some basic principles always apply:

• You will never be identified by name in any research paper published about the clinical trial.
  
• The FDA can inspect the medical records of participants in clinical trials, but federal laws protect that information from being used elsewhere.
  
• Unless otherwise specified, researchers never give information that can identify you to anyone not involved in the clinical trial.
  

Q: Does the U.S. government require clinical trials?

A: The FDA requires companies to show that new medical products are both safe and effective before approval. Clinical trials are the best way to prove that. Beware of advertisements for products that have never been FDA-approved, such as products that claim they will make your hair grow. We really don’t know if those products work because they have not been properly tested.

Q: How do I find a clinical trial that’s right for me?

A: You can identify trials that are open to enrollment by asking for a referral from your doctor, searching web sites of teaching hospitals or medical schools, or contacting a clinical trial matching service.

Q: Does Lehigh Valley Hospital participate in clinical trials?

A: Yes. At any given time, we participate in hundreds of clinical trials in many different areas of medicine.

Q: How do I find out about enrolling in a trial?

A: Most trials are advertised in the newspaper and include a phone number for you to call. Others recruit participants through doctor’s offices. To find out about clinical trials at Lehigh Valley Hospital, call 610-402-CARE. To search all clinical trials underway in the United States, visit http://clinicaltrials.gov/.

ARTICLE TOOLS: