# Presentation: 075462

## Clinical Trials

- The Way We Make Progress Against Disease

**Notes:**
Today I’m going to talk about clinical trials, and why they are important for all of us.

I’m also going to review a little about:
 Different types of trials and how they work 
 How patients are protected
 Pros and cons of participating in clinical trials

## What Are Clinical Trials?

- What Are Clinical Trials?

- Research studies to find better ways to prevent, detect, or treat disease
- Help health care providers find ways to improve patient care

**Notes:**
Clinical trials are research studies involving people. 

Each study tries to answer scientific questions and find better ways to prevent, diagnose, or treat diseases (including <insert condition of interest to audience>; Note: check ClinicalTrials.gov to find out if studies currently being conducted on this condition). 

Clinical trials contribute to knowledge about and progress against disease.

## Why Are Clinical Trials Important?

- Why Are Clinical Trials Important?

- Most of the best treatments we have today are based on what we learned from clinical trials
- People are living longer because of clinical trials

**Notes:**
Clinical trials translate results of basic scientific research into better ways to prevent, diagnose, or treat disease.

Many of today’s most effective disease treatments are based on previous studies done in the past. Because of progress made through clinical trials, many people are now living longer.

## Do Many People Take Part in Clinical Trials?

- Do Many People Take Part in Clinical Trials?

- Few people take part
- The more people who take part, the faster we will find better ways to treat and prevent disease

**Notes:**
We know that few people in the U.S. participate in clinical trials.  

According to the National Cancer Institute, for example, fewer than 5 percent of adult cancer patients in the U.S. participate in clinical trials.

 Why is this? 

There are many myths and fears about clinical trials. 

When people think about clinical trials, many imagine “guinea pigs”participants getting inferior treatment or a sugar pill (placebo) instead of actual medical or dental treatment. Many people also think that clinical trials are for only the people who have no other treatment options available to them. Others are never offered the opportunity to participate.

The more people who participate in clinical trials, the faster we can answer the critical research questions that will lead us to better treatment, diagnosis, and prevention for all types of diseases. 

So, if more people learn about clinical trials and understand how they work, more people may be willing to participate. 

By learning the facts about clinical trials today, you can address the myths and fears, and help others who need to know this information.

## What Are the Different Types of Clinical Trials?

- Treatment
- Prevention
- Diagnostic
- Screening/early detection
- Quality of life

**Notes:**
It is important to know that there are different types of clinical trials.

Treatment trials test new treatments—like a new drug, new approaches to surgery or radiation therapy, new combinations of treatments, or other new approaches.

Prevention trials test new approaches, such as medicines, vitamins, minerals, or other supplements that doctors believe may lower the risk of certain types of diseases. These trials look for the best ways to prevent a disease in people who have never had it.

Although I’m not going to be talking about them today, other types of trials look to find:
 The best ways to detect a disease, especially in its early stages 
 Ways to improve comfort and quality of life for patients

## Treatment Trials

- What new treatments can help people with a particular disease?
- What is the most effective treatment for people with that disease?

**Notes:**
Most clinical trials are treatment trials. These clinical trials involve people who have a disease. 

These studies try to answer specific questions about the effectiveness of a new treatment or a new way of using an existing treatment. 

## Treatment Trials

- Treatment Trials

- Many treatment trials compare two or more different approaches to treating a disease
- Participants will take either:
- The best accepted treatment
- A new treatment

**Notes:**

Participants have an equal chance of being assigned to one of two or more groups receiving either:
 The best accepted treatment for the disease (standard treatment) 
 A new treatment that doctors have reason to believe will be better than the standard treatment

IT IS IMPORTANT TO REMEMBER that placebos—or sugar pills—are almost never used in treatment trials. All patients are treated for their disease.

But people who have diseases for which no standard treatment is available may take part in a trial that compares a new treatment with a placebo. Placebos or “sugar pills” are used only when there is no standard treatment available.

## Prevention Trials

- What approaches can prevent healthy people from developing disease?

**Notes:**
Unlike treatment trials, prevention clinical trials are studies involving healthy people who are at high risk for developing a particular disease. These studies try to answer specific questions about and evaluate the effectiveness of ways to reduce the risk of disease. 

## Prevention Trials

- 	Two kinds, that ask participants to either:
- 1.  Do something
- 2.  Take something

**Notes:**
There are two kinds of prevention trials:
 One kind focuses on finding out whether actions people take, such as exercising more or quitting smoking, can prevent disease. 
The other kind focuses on finding out whether taking certain medicines, vitamins, minerals, or food supplements (or a combination of them) may lower the risk of a disease. 

Placebos are used in prevention trials when we don’t yet have a known approach (standard agent—i.e. drug or compound) for disease prevention. 

## Protecting Patients’ Safety

**Informed Consent**
- Before agreeing to take part, patients have the right to understand all that is involved in a clinical trial:
- Procedures and treatments
- Tests
- Possible risks and benefits

**Notes:**
Many people think that participant rights are not protected in clinical trials. They may remember past abuses of research participants, such as those that occurred during the infamous Tuskegee Syphilis Study. 

Today, Federal regulations help ensure that all Government-sponsored clinical trials are run in an ethical manner.

One of the most important ways patients are protected is through informed consent, which is required by law.

Before someone joins a clinical trial, a health care provider will explain why the trial is being done, and what will happen during the trial. Potential participants can ask any questions they have about the trial.

Potential participants are also given an informed consent form to read. The informed consent form includes written details about the information that was discussed, and also describes the confidentiality of the participant’s records.

If the person decides to join the trial, he or she is asked to sign the informed consent form.

Even after participants sign the consent form, they can still change their minds, and stop at any time. They will have the chance to discuss other treatments or care with a doctor from the trial. 

## Protecting Patients’ Safety

- Institutional Review Board** **
- Committee made up of experts

**Notes:**
Each clinical trial is reviewed by a group of experts to make sure that it is going to be conducted in a safe and ethical way. This group is called an institutional review board (IRB).

IRBs are made up of people who are qualified to evaluate new and ongoing clinical trials on the basis of scientific, legal, and ethical merit. The board members determine whether the risks involved in a trial are reasonable with respect to the potential benefits. IRBs also monitor the ongoing progress of trials from beginning to end.

## Benefits of Taking Part

- Possible benefits:
- Patients will receive, at a minimum, the best standard treatment
- If the new approach is proven to work, patients may be among the first to benefit
- Patients have a chance to help others and improve health care

**Notes:**
Making a decision about taking part in a clinical trial is a very personal one. This is a question that only the person with the disease (or at high risk for the disease) can answer for him or herself.

Some of the possible benefits of participating in a clinical trial are:
 Participants are closely monitored for any side effects and may stop their participation at any time. 
Participants have access to new disease treatment or prevention approaches before they are widely available. 
Participants have an opportunity to be part of a research effort that may help others.

## Risks of Taking Part

- Possible risks:
- Unknown side effects or other risks
- New treatment may not help every participant
- Costs

**Notes:**
While a clinical trial is a good choice for some people, there are possible risks. People need to consider these as they think about joining a trial.

Some of the possible risks of participating in a clinical trial are:

 New approaches may have side effects or risks that are unknown.  
 Even if a new treatment under study has benefits, it may not work for every participant. Even standard treatments proven effective for many people do not help everyone.
 Health insurers and managed care providers do not always cover all the care costs in a clinical trial. Participants may have to deal with the costs of travel, childcare, lost work hours, and meals.

## Where to Find Clinical Trial Information

- Where to Find Clinical Trial Information

**Your health care provider**
**National Library of Medicine**
-     www.ClinicalTrials.gov

- 

**Notes:**
You can ask your health care provider about local clinical trials.

You can go to www.ClinicalTrials.gov.  The ClinicalTrials.gov website provides patients, family members, health care professionals, and members of the public easy access to information on clinical trials for a wide range of diseases and conditions. The National Institutes of Health (NIH), through its National Library of Medicine (NLM), has developed this site in collaboration with all NIH Institutes and the Food and Drug Administration (FDA). 
Search by keyword or browse the Mouth and Tooth Diseases page. 

## 				National Institute of Dental and 		Craniofacial Research		NATIONAL INSTITUTES OF HEALTH			www.nidcr.nih.govAdapted from a slide presentation developed by the National Cancer Institute, for its Cancer Clinical Trials Education Series.