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Participant Information

  1. What are clinical trials and why do you need participants?
  2. What is the difference between a clinical trial and clinical research?
  3. How does the outcome of clinical research make a difference?
  4. Why should I register?
  5. What questions should I ask if I am offered a clinical trial?
  6. What do I need to know to decide if I want to participate in a clinical trial?
  7. What should I expect at a trial?
  8. What should I bring to a trial?
  9. Do I need to fill out forms? If so, why?
  10. What happens after a clinical trial is completed?
 

WHAT ARE CLINICAL TRIALS AND WHY DO YOU NEED PARTICIPANTS?
Clinical trials are a way for researchers to determine if a new product actually can prevent, detect or treat illness or disease. Clinical trials will also see if the product has side effects and what they might be. Participants are needed because products react differently when used on humans as opposed to what the response you might get in a lab.

 

WHAT IS THE DIFFERENCE BETWEEN A CLINICAL TRIAL AND CLINICAL RESEARCH?

  1. Clinical research is medical research that investigates new ways to treat, detect and prevent illness and disease.
  2. Clinical trials test new products that have been discovered as a result of medical research. A clinical trial is also known as a clinical research study.
 

HOW DOES THE OUTCOME OF CLINICAL RESEARCH MAKE A DIFFERENCE?
If all phases of a clinical trial give the results the developers hope for, many people can eventually get help for their ailments.

 

WHY SHOULD I REGISTER? Click here to register
People participate in clinical trials for a number of reasons:

  1. Healthy volunteers may participate because they want to help researchers find better treatments for people who are ill
  2. Volunteers with an illness or disease may participate because they want to try the newest treatments being investigated and/or to have extra care and attention
 

WHAT QUESTIONS SHOULD I ASK IF I AM OFFERED A CLINICAL TRIAL?
You might want to ask the following questions:

  1. What is the purpose of the study?
  2. Why do researchers think this product may be effective?
  3. How is participant safety being checked?
  4. How long will the study last?
  5. What will my responsibilities be if I participate?
  6. What are my possible short-term benefits?
  7. What are my possible long-term benefits?
  8. What are my short-term risks, such as side effects?
  9. What are my long-term risks?
  10. What can I expect from a clinical trial and will it hurt?”
  11. Will I be able to take my regular medications while in the clinical trial?
  12. Where will I have my medical care?
  13. What if I have a problem, what shall I do?”
  14. How could being in this study affect my daily life?
  15. Can I talk to other people in the study?
  16. Will I have to pay for any part of the trial?
  17. Will I have to pay travel or child care costs while I am in the trial, or does the trial cover these costs?
 

WHAT DO I NEED TO KNOW TO DECIDE IF I WANT TO PARTICIPATE IN A CLINICAL TRIAL?
You need to know:

  • Clinical trials are carefully designed to protect the participants.
  • Clinical trials are approved and monitored by the IRB, an Institutional Review Board, that ensures the risks to participants are minimal and worth any potential benefits. The IRB also ensures that the clinical trials are ethical and participant rights are protected.
  • Participants must give informed consent, which is stating that they have been provided with information about risks and potential benefits; and provided with information about the study, such as purpose, duration, and required procedures.
  • Factors such as how much time is needed, discomfort or risk depends on the trial.
  • Study procedures may not benefit the participant.
  • All clinical trials have guidelines about who can participate. Criteria are based on factors such as age, gender, type and stage of a disease, previous treatment history, and medical conditions.
  • It is very important for you to be honest when answering eligibility criteria questions in order to avoid the risk to yourself.
  • While most clinical trials pose the risk of only minor discomfort, some study participants may experience complications that require medical attention. In rare cases, participants have been seriously injured or died.
  • Potential benefits of participating in a clinical trial are the opportunity for participants to play an active role in their health care, gain access to new research treatments before they are widely available, and receive regular and careful attention from a research team that includes doctors and other health professionals.
  • That you may receive a placebo, an inactive product that resembles the study product but without medical value.
 

WHAT SHOULD I EXPECT AT A TRIAL?
You may be asked for blood samples and to undergo a short medical exam. This can be a lengthy process, so plan on being be flexible with your time, depending on circumstances.

 

WHAT SHOULD I BRING TO A TRIAL?
You should bring:

  1. All medications you are taking
  2. Food or snacks if you have special dietary needs
  3. A sweater in case you get cold
  4. A book or other quiet entertainment in case you have to wait
  5. Identification (e.g. Driver’s License)”
 

DO I NEED TO FILL OUT FORMS? IF SO, WHY?
Yes, you do have to fill out forms. It’s required that we have your complete medical history, which is necessary to ensure you meet all inclusion and exclusion requirements. Your history is kept confidential.

 

WHAT HAPPENS AFTER A CLINICAL TRIAL IS COMPLETED?
After the clinical trial is finished, researchers will carefully study the information collected during the trial. They will analyze the findings to determine their meaning and then decide whether to move on to another phase of testing or to stop testing. There are multiple phases of testing. After the last phase, the researchers will decide whether the results are medically important. If they are, pending FDA approval product developers will determine whether they want to market the product. Results may also be published in scientific journals.