Frequently Asked Questions (FAQ)

 

What is a Clinical Research Trial?

Clinical Research Trials, also known as Clinical Studies, are conducted in countries all over the world. There primary purpose is to see if a new investigational drug or device can improve the treatment and management of acute and/or chronic diseases in the future. Most Clinical Drug Trials are supported by Pharmaceutical or Biotech companies. The National Institute of Health (NIH) is funded by the US Congress. NIH provides funds for research projects being conducted in hospitals, clinics and universities in the United States.

The Food and Drug Administration (FDA) is the approval authority for any new drug or device that is being used in the United States. They are responsible for making sure that any new product or device is SAFE, EFFECTIVE and works in ALL people.

A "good" Clinical Trial has participants of all ages, gender and racial backgrounds depending on the disease state being treated. It is through your participation in Clinical Trials that we can assure that any new drug or device that is released for public use is safe and effective in African Americans and other minority populations.

 

Why is it So Important for African Americans to Participate in Clinical Trials?

According to the latest National Minority Quality Report, African Americans and other minority populations have the worst health outcomes in the United States. Minority Populations have a high rate of diabetes, heart disease, cancer, asthma and HIV/AIDS. Due to lack of participation in clinical trials over the years, very little is known about how African Americans respond to various treatments. We know that African Americans metabolize some drugs differently than Caucasians and that some drugs may require higher doses to get the same effect. We also know that there are certain medications that cause different side effects in African Americans than seen in Caucasians.

By having a more African Americans involved in clinical trials, scientists will learn how the different treatments work in different populations and can improve overall health of everyone in the United States that will potentially receive the drug.

 

How are Volunteers for Clinical Trials Protected from Dangerous or Harmful Effects of New Drugs or Devices?

In the past, the clinical experimentation on African Americans has received a lot of attention. The most infamous example was the Public Health Services Syphilis Study where African American Men with Syphilis were left untreated for 40 years even though Penicillin (a known cure) was available. Due to the lack of ethical conduct from this study, there have been laws, regulations and a code of ethics established to guarantee the protection of clinical research volunteers. In addition all studies now have an independent Safety Board to make sure there are no unforeseen issues with the drug or device.

 

What Should you Consider Before Enrolling in a Clinical Trial

Benefits

  • Receiving study-related care for your condition
  • Having early access to new investigational medications and devices
  • Knowing your participation has the potential to help others in the future

Risks

  • Not being able to choose your treatment
  • Receive a treatment that may not work as planned
  • Coming to the doctor’s office more frequently than usual
  • Experiencing unpleasant or serious side effects
 

What Questions Should You Ask Before Participating in a Clinical Trial?

Remember, that participating in a clinical trial will require a commitment of time and a willingness to complete the trial.

Questions to Ask:

  • What type of clinical trial is this and what is the goal of the study?
  • What types of patients are being enrolled in the study?
  • How will I know if I am getting the study drug or the inactive placebo?
  • What will I have to do to fully participate in the study?
  • How long will the study last?
  • Will my insurance cover all of my tests, hospitalization, office visits and medication.
  • Will I receive a stipend for my time, travel or childcare expenses?
  • What are the potential side effects of the study drug?
  • If the study treatment works, can I remain on the drug after the study is over?
  • How will I know if the study drug is not working?
  • Can I change my mind and withdraw for the study without any problems?
 

How Can I Find Out More About Clinical Research Trials?

First, you should find out if your primary care physician or specialist is already participating in a clinical trial. Over the past 10 years there has been an increasing number of minority physicians participating in clinical trials sponsored by pharmaceutical and biotech companies. Let your doctor know you’re interested in participating in clinical research as a way to give back to your community.

For specific information or to register for a trial:

www.healingourvillage.com/clinicalresearch
Healing Our Village provides information of chronic disease management as well as how to sign up to participate in a clinical trial in your area.
800-788-0941

There are a number of websites that can provide more information regarding clinical trials:

www.clinicaltrials.gov
This service of the National Institutes of Health (NIH) contains information about all of the clinical trials being done by the NIH, universities, pharmaceutical companies, etc.

www.nimhd.nih.govv
Visit the website of the National Office of Minority Health for information about minority health issues. 800-444-6472

www.SearchClinicalTrials.org
Find current clinical research projects in your area plus study results and health information on this easy-to-use website.

Download PDF on Building Trust and Confidence in Clinical Research