Patient's Frequently Asked Questions (F.A.Q.)

1. What is a clinical trial?

2. Why should I participate in a clinical trial?

3. What are the benefits of participating in a clinical trial?

4. Will it cost me anything to participate?

5. Will I be compensated for my participation?

6. Who sponsors a clinical trial?

7. How long do visits last?

8. How long do studies last?

9. What are the risks associated with clinical trials?

10. What if I have a problem?

11. Is my study participation confidential?

12. What if I want to keep taking the medication?

13. What is informed consent?

14. What are the study participant's responsibilities?

15. What protection does a patient have as a participant in a clinical trial?

16. Can patients be involved in a clinical trial without their knowledge?

RESPONSES:

1. What is a clinical trial?

A clinical trial is the scientific evaluation of the safety and effectiveness of a new investigational medical treatment, medication or device in human volunteers. After showing considerable benefit in the laboratory, new treatments must be tested among animals and then among small groups of people for safety reasons. Carefully selected doses are then tested in large groups of volunteers to evaluate the safety and effectiveness of the treatment for a specific condition such as diabetes or high blood pressure.

2. Why should I participate in a clinical trial?

Clinical trials are important to ensure that individuals receive safe and effective treatments for their health conditions, from heart disease to headaches. They provide the means to develop new treatments that are as effective, more effective, or safer than treatments already on the market, they enable researchers to discover new therapeutic uses for currently available medications and they make it possible to develop innovative treatments for conditions that currently have no treatment.

3. What are the benefits of participating in a clinical trial?

People participate in clinical trials for various reasons, including health, financial, and personal needs. Volunteers who participate in clinical trials help to further advance medical science, which may help 
others in the future. While there are no guarantees that participants will benefit from the research treatment they receive, some may find that the study medication relieves their condition more effectively 
and with fewer side effects than their previous treatment plan. Clinical trials sponsored by pharmaceutical companies often provide free study medication and study-related care. In addition, financial compensation for time and travel expenses may be provided to study participants in some clinical trials.

4. Will it cost me anything to participate?

There is no cost for joining a clinical trial, and study medication as well as study-related tests and procedures are usually provided at no charge to study participants. It is important to ask the research staff to explain exactly what charges, if any, may be the responsibility of the study participant.

5. Will I be compensated for my participation?

Most studies will reimburse study participants for time. Study related procedures such as physical exam, diagnostic laboratory studies and study medication are free to study participants.

6. Who sponsors a clinical trial?

Most clinical trials are sponsored by pharmaceutical companies, federal health agencies, medical foundations, medical centers, and universities; however, physicians may sponsor some clinical trials, 
particularly when the trial evaluates a currently available treatment for a condition other than for what it was previously approved.

7. How long do visits last?

This will also vary depending on the clinical trial. Most visits for any study at our clinic are at least 30 minutes and some may be up to a few hours. The initial visit will be longer because it will be necessary to assess your history and discuss the consent. The initial visit usually is the longest.

8. How long do studies last?

This varies depending on the clinical trial. This information would be made available to you once you have qualified for a particular study.

9. What are the risks associated with clinical trials?

A study patient before any participation in the study signs an informed consent. The informed consent will describe any known side effects and risks associated with study medication in addition to outlining any other procedures that will be required during the course of the study.

10. What if I have a problem?

If you feel you are having problems with study medication, you should contact the research office and speak with the study coordinator who has been assigned to you during the study. If a clinician feels you may be experiencing problems with the study medication, it may need to be discontinued.

11. Is my study participation confidential?

Patient confidentiality is maintained as much as possible during and after a clinical trial. Outside of the research team, a participant's name may not be disclosed without the permission of the participant unless required by law. Generally, the Sponsor, the F.D.A., and the IRB have access to the study patient's medical records. To ensure confidentiality, volunteers are assigned a patient number once they are enrolled in a trial and are identified by this number and their initials for the duration of the study. 

Information obtained during the course of the study will be retained in confidential files at N.E.C.C.R.; however, data, which contains your identity, will be subject to disclosure in certain circumstances. 

The Sponsor may use the data to seek approval from the Food and Drug Administration. At any time during or after the study, representatives of the Food and Drug Administration, members of the institutional review board, or the Sponsor may inspect the files and your medical records. On rare occasions, the law may also require disclosure to regulatory bodies or other third parties.

12. What if I want to keep taking the medication?

Because most of the medications we study are investigational and have not yet been approved by the FDA, continuing the medication after your clinical research participation ends may not be an option. We will provide you with appropriate referrals for treatment at the end of your study participation.

13. What is informed consent?

Informed consent is the process by which a potential study participant is provided with information about the study and treatment before deciding whether or not to participate in the trial. It includes an 
explanation of what is involved in the trial, the duration of the study, the frequency and length of the required visits, as well as the known risks and benefits associated with the study treatment. 

Participation in a clinical trial is completely voluntary. All questions about the study should be answered to the patient's satisfaction before an informed consent form (ICF) is signed. Patients have the right to refuse participation or to withdraw their consent at any time during the study without penalty. 

The wishes and best interest of the patient are considered at all times and, throughout the trial, participants will be provided with any new information that may affect their decision to continue their 
participation in the study. In addition, the study physician may withdraw a patient at any time, without the patient's consent, if it becomes evident that the treatment is not in the patient's best interest.

14. What are the study participant's responsibilities?

In the interest of safety, the participant must fully inform the study physician about past and current medical conditions, illnesses and medications, follow the prescribed treatment plan, and attend the 
scheduled visits. Other study-specific responsibilities will be explained by study personnel.

15. What protection does a patient have as a participant in a clinical trial?

Clinical trials are governed by clearly defined ethical and legal codes. In 1981, regulations of the Food and Drug Administration made it a requirement that all federally regulated clinical trials be reviewed 
and approved by an Institutional Review Board (IRB) before and during the course of the trial. An IRB is a committee of volunteers including experts and lay people such as doctors, scientists, clergy, and other community members. Their primary goals are to protect the public, to evaluate whether the potential benefits of study participation outweigh the risks, and to ensure that patients are not coerced into participating in a clinical trial. 

Patients may call the IRB with questions about their rights as a research participant. The name and telephone number of the IRB overseeing the clinical trial is included in the informed consent form.

16. Can patients be involved in a clinical trial without their knowledge?

Patients may not be enrolled into a clinical trial without their knowledge and written consent. American citizens are now protected under strict federal regulations preventing the unauthorized use of 
investigational treatments. In the case of minors, a parent or legal guardian may provide consent for a child to participate in a clinical trial.