# Presentation: 097208

## Minority Recruitment and Adherence in Clinical Trials

- Doris Browne, MD, MPH
- Program Director
- Breast and Gynecologic Cancer Research Group
- Division of Cancer Prevention
- National Cancer Institute

## What Are Cancer Clinical Trials?

**What Are Cancer Clinical Trials?**

- Research studies involving people
- Try to answer scientific questions and find better ways to prevent, diagnose, or treat cancer

**Notes:**
Clinical trials are research studies involving people. Clinical trials are the final step in a long research process that includes preliminary laboratory research and animal testing.

Clinical trials try to answer specific scientific questions to find better ways to prevent, detect, or treat diseases, or to improve care for people with diseases. 

In cancer research, a clinical trial is designed to show how a certain anticancer approach—for instance, a promising drug, a new surgical procedure, a new diagnostic test, or a possible way to prevent cancer—affects the people who receive it.

## Why Are Cancer Clinical Trials Important?

**Why Are Cancer Clinical Trials Important?**

- Cancer affects all of us
- Each year in the U.S.A:
- More than half a million people are expected to die of cancer—more than 1,500 people a day
- 1 of 4 deaths is from cancer
- More than 1 million new cancer cases are expected to be diagnosed

**Notes:**
It is important to understand that cancer affects us all, whether we have it, care about someone who does, or worry about getting it in the future.

Each year in the United States:*
 About half a million people are expected to die of cancer—more than 1,500 people a day. It is the second leading cause of death, exceeded only by heart disease
 More than 1 million people are diagnosed with cancer

How many people find this surprising?

* American Cancer Society. (2001). Cancer facts and figures. Atlanta, GA.

## Why Are Cancer Clinical Trials Important?

**Why Are Cancer Clinical Trials Important?**

- Clinical trials translate results of basic scientific research into better ways to prevent, diagnose, or treat cancer
- The more people that take part, the faster we can:
- Answer critical research questions
- Find better treatments and ways to prevent cancer

**Notes:**
It is important to understand what clinical trials do to fight cancer:
         Clinical trials translate results of basic scientific research into better ways to prevent, diagnose, or treat cancer.
         Clinical trials contribute to knowledge and progress against cancer. Many of today’s most effective cancer treatments are based on previous study results. Because of progress made through clinical trials, many people treated for cancer are now living longer.
         The more people that participate in clinical trials, the faster we can answer the critical research questions that will lead us to better treatment and prevention options for all cancers. 

## Cancer Prevention Trials

- Evaluate the effectiveness of ways to reduce the risk of cancer
- Enroll healthy people at high risk for developing cancer

**Notes:**
Unlike treatment trials, cancer prevention clinical trials are studies involving healthy people who are at high risk for developing cancer. 

These studies try to answer specific questions about and evaluate the effectiveness of ways to reduce the risk of cancer. 

## Today’s Standard Treatment 
Was Yesterday’s Clinical Trial

***Today’s Standard Treatment ***
***Was Yesterday’s Clinical Trial***

**Notes:**
Defining Diabetes
Diabetes is one of the most serious health challenges facing us in this country.  
It is a condition in which the body fails to produce or respond to insulin.  Our bodies require insulin. Insulin enables glucose (another word for sugar) to leave the blood and enter body cells where it is used as fuel.   

## Minority Recruitment to Clinical Trials

- Few minority patients and physicians participate in clinical trials
- Most drugs are approved without minority participation
- Using genetics to make targeted medicines
- Drugs approved based on foreign data
- Expectation that approved drugs will work for all (including minorities)

## The Past Abuses

- Pre- and post- Civil War Medical Experimentation
- Tuskegee Syphilis Experiments
- “Student or Night Doctors”

**Notes:**
Risk Factors - Type 2 
Diabetes tends to be more common in individuals with some or any of the above characteristics. Anyone with two or more of these risk factors should be tested for diabetes.

## Barriers to, Benefits of, and Risks of Participation in Clinical Trials

## Barriers to Participation in Clinical Trials

- Physicians and other health providers may:
- Be unaware of appropriate trials
- Be unwilling to lose control of patient’s care
- Believe that standard therapy is best
- Believe that clinical trials are more work
- Harbor concerns about the patient’s care or how the person will react to suggestion of clinical trial participation

## Barriers to Participation in Clinical Trials

- Patients may:
- Be unaware of clinical trials
- Lack access to trials
- Fear, distrust, or be suspicious of research
- Have practical or personal obstacles
- Face insurance or cost problems
- Be unwilling to go against their physicians’ wishes

## Reasons Minorities Don’t Participate in Clinical Trials

- Unaware of clinical trials
- No access to healthcare
- The doctor didn’t recommend it
- Distrust of medical research
- Negative past experiences with the healthcare system
- Cultural beliefs or myths
- Racial and ethnic discrimination

**Notes:**
Risk Factors - Type 2 
Diabetes tends to be more common in individuals with some or any of the above characteristics. Anyone with two or more of these risk factors should be tested for diabetes.

## Benefits of Participation

- Possible benefits:
- Subjects will receive, at a minimum, the best standard treatment
- If the new treatment or intervention is proven to work, subjects may be among the first to benefit
- Subjects have a chance to help others and improve cancer 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 cancer (or at high risk for cancer) can answer for him or herself.

Some of the possible benefits of participating in a clinical trial are listed here.

## Benefits of Minority Participation

**Benefits of Minority Participation**

- Better targeted medicines
- Access to, and experience with  the newest treatments before they are available to others
- Very carefully watched health
- Most study treatment at no cost
- Providing scientific help to others

**Notes:**
Type 1
Emphasis usually
There are two types of diabetes.  Type one usually occurs in children.  However, diabetes can occur in all age groups.  For the purposes of this program, we will emphasis Type 2.  See next slide.

## Risks of Participation 

- Possible risks:
- New treatments or interventions under study are not always better than, or even as good as, standard care
- Even if a new treatment has benefits, it may not work for every subjectt
- Health insurance and managed care providers do not always cover clinical trials

**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 listed here.

## Possible Risks & Inconveniences for Minorities

- Potential or unexpected side effects
- Placebo treatment
- May not work for you
- Unknown risks
- Time; additional cost
- May have to stop taking other medications
- Transportation

**Notes:**
Risk Factors - Type 2 
Diabetes tends to be more common in individuals with some or any of the above characteristics. Anyone with two or more of these risk factors should be tested for diabetes.

## Protection of Participants

- Nuremberg
- National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
- Belmont Report
- National Research Act

## Who is Watching Out for the Subject’s Interest

- The National Institutes of Health
- The Food and Drug Administration
- The Institutional Review Board
- The Clinical Investigator
- Health Care Provider
***Subject’s knowledge of the process***

**Notes:**
Diabetes and Americans
Diabetes can be found in people of varying age groups, economic status, social classes and races. 
As previously mentioned, one of this country’s major challenges is identifying the large number of people who are unaware that they have the disease and providing them clinical care for their diabetes.

## Government Oversight of Safeguards for Participants

- Office for Human Research Protections (OHRP)
- The Common Rule
- FDA Regulations

## Protecting Participants Before a Trial

- Scientific review by sponsoring organization
- Institutional review board approval
- Informed consent

## Protecting Participants During a Clinical Trial

- Institutional review boards (IRBs)
- Data and safety monitoring boards (DSMBs)
- Minimize risks
- Ensure integrity of data
- Can stop study if necessary

## Questions: Ask & Answered

- What is the study about?
- Who put the study together?
- Where is the trial being conducted?
- What will the patient get out of the study?
- What are the risks?
- How long will the study last?
- What tests are involved?

**Notes:**
Concerns for Women with Diabetes
High blood sugar provides a good source of food for the growth of germs.  Women with diabetes are more likely to have vaginal infections.

## Questions: Ask & Answered

- How will I be protected from harm?
- Do I have to pay for any part of the trial?
- Who should be contacted for problems or questions?
- What do I have to do in this study?
- What are the other options?

**Notes:**
Concerns for Women with Diabetes
High blood sugar provides a good source of food for the growth of germs.  Women with diabetes are more likely to have vaginal infections.

## Subject’s Decision & Rights 

- The decision to participate is _the subject’s_
- Informed Consent is more than a signature - it is a process that your health care provider should walk you through
- All the facts about a study must be given before the patient decides to participate
- Including details about the treatments and test(s) they may receive and the benefits and risks
- Patient rights should be fully explained

**Notes:**
Concerns for Women with Diabetes
High blood sugar provides a good source of food for the growth of germs.  Women with diabetes are more likely to have vaginal infections.

## How to Find Clinical Trials

- The Internet
- National Library of Medicine
- http://www.ClinicalTrials.gov
- Centerwatch Clinical Trials
- http://www.centerwatch.com
- NCI/CancerNet
- _[http://cnetdb.nci.nih.gov/trials.html](http://cnetdb.nci.nih.gov/trials.html)_
- Your healthcare provider
- CIS: 1-800-4-CANCER (1-800-422-6237)
- Newspaper, radio, or television

**Notes:**
Concerns for Women with Diabetes
High blood sugar provides a good source of food for the growth of germs.  Women with diabetes are more likely to have vaginal infections.

## NCI Information Resources

**NCI Web site****w**ww.cancer.gov
**Cancer Information Service**
- 1-800-4-CANCER
- TTY- 1-800-332-8615
- www.cancer.gov/cis

- 

- 

**Notes:**
NCI’s Web site, www.cancer.gov, provides access to NCI’s clinical trial registry, which contains more than 1,800 ongoing clinical trials, with information about studies around the world. All clinical trials undergo review prior to inclusion.  

Although no single resource lists every cancer clinical trial being conducted in the United States and abroad, NCI’s registry is the most comprehensive, and contains information about trials sponsored by NCI, the pharmaceutical industry, and some international groups.  

You  can narrow your search by looking at stage of disease, phase of trial, treatment modality, and geographic location—so it is possible for us to locate trials going on here in our community.

(You may want to mention local information sources for clinical trials in your community.)

Another resource is the CIS toll-free telephone service (1–800–4–CANCER). Through this service,  callers speak with knowledgeable, caring staff who are experienced at explaining medical information in terms the public can easily understand. CIS information specialists answer calls in English and Spanish. They also answer calls from the deaf and hard of hearing through the toll-free TTY number (1–800–332–8615) . CIS staff have access to comprehensive, accurate information from the NCI on a range of cancer topics, including the most recent advances in cancer treatment. They take as much time as each caller needs, provide thorough and personalized attention, and keep all calls confidential.  Calls are answered 9:00 a.m. to 4:30 p.m. local time, Monday through Friday. 

The CIS also provides live, online assistance to users of NCI Web sites through LiveHelp, an instant messaging service that is available from 9:00 a.m. to 5:00 p.m. Eastern time, Monday through Friday. Through LiveHelp, information specialists provide answers to questions about cancer and help in navigating NCI Web sites.

The CIS also provides recorded information 24 hours a day, 7 days a week, through 1–800–4–CANCER. Callers can  select option 4 to hear recorded information at any time.