Frequently Asked Questions For Clinical Trials Patients

1 . What are the pros and cons of participating in a clinical trial? On the positive side, all clinical trial patients receive quality medical care and may receive early access to experimental drugs that may prove beneficial in treating people with life-threatening conditions. Clinical trials patients also help with the development of safer and better drugs for future generations.

Conversely, the new drug or treatment may not be any better and may be worse than standard care, or it may have undesirable side effects. Furthermore, you may incur costs that are not covered by your healthcare plan.

2. How do you find out about clinical trials? Information on becoming a clinical trials patient can be found checking with your doctor or searching clinical trial registries on Web sites such as www.clinicaltrials.gov or www.ciscrp.org.

3. How does the FDA approve drugs? The Food and Drug Administration (FDA), and other similar regulatory authorities worldwide, are charged with ensuring the safety and effectiveness of all prescription drugs marketed in the U.S.

Before the FDA gives the drug manufacturer approval for marketing a given drug, it considers two primary points:

• whether the clinical trials provide substantial evidence that the drug is effective, and
• whether the drug is safe under the conditions outlined in labeling.

Ultimately, what the FDA considers is whether the benefits of the drug outweigh its risks. For life-threatening diseases, the FDA has mechanisms that allow the approval process to be condensed so the treatment can be used and brought to market in an accelerated manner.

4. What questions should I ask before I agree to be a clinical trials patient? You have the right to ask any number of questions of the clinical trial doctors and sponsors prior to volunteering.

Some questions may include:

• Has this drug been tested on humans before? If so, to what extent?
• What is the purpose of the drug?
• What are the perceived risks?
• Which company developed the drug?
• Will there be any invasive procedures carried out?
• What is the samples type and how often will they be taken?
• How long does the trial last?

5. What does informed consent mean? Informed consent refers to the process by which volunteer patients discover the details of their clinical trial. Patients must be provided all facts about a trial prior to giving consent to participate, including treatment details and possible risks and benefits. The informed consent form must be signed by patients prior to participation. The informed consent process continues throughout the clinical trial.

6. How are clinical trial patients protected? Clinical trial protocols are developed to ensure that patients are not put at undue risk. These protocols are carefully reviewed by a committee of experts and lay persons, called an Ethics committee, before testing can commence. As a volunteer, you have the right to refuse treatment at any point in the clinical trial and leave at any time and for any reason. If doctors discover that the study treatment is harmful to you, you have the right to leave the trial and return to your doctor's care.

7. Who can participate in a clinical trial? Each clinical trial has guidelines for patients based on specific factors, such as age, type of disease, medical history and current health. Depending on the trial, sponsors may seek healthy individuals or those with the particular illness under study. Inclusion and exclusion criteria are used to determine which participants are chosen for the trial.

8. Where are clinical trials conducted?  For Phase I, volunteers stay within the clinical unit throughout the trial and generally are not allowed to leave the premises due to safety reasons. Patient trials may be conducted at other medical facilities and may not require you to stay for the duration.

9. What happens in a clinical trial? At its most basic level, a clinical trial is where patients are given test treatments and doctors carry out research on how the treatment affects study patients. Some patients do not actually receive the test treatment, but instead receive a placebo or standard treatment as part of the "control" group. Your progress is followed closely by doctors.

10. Will my insurance/provider pay for the clinical trial expenses? Not always. Make a point to find out up front whether your health insurance or managed care provider will cover the costs of a given clinical trial. Speak with one of the clinical trial's doctors about cost issues before you volunteer as a participant.

11. Why should I consider getting involved in a clinical trial? There are many individual & personal reasons for participation. Appreciation for the benefits such involvement could have for future generations. Assisting in the process that uncovers more successful medicines, which at times benefit serious or life-threatening conditions. Drugs on trial today could go on to become the licensed drugs of ‘tomorrow’, and benefit you or family members. Others enjoy the social interaction or reward, filling a gap in their lives.

12. How safe are clinical trials? Strict guidelines are followed and experts review the trials to ensure patients are not subjected to undue risk.  However, all trials contain some form of risk.

13. How long do clinical trials last? Phase I trials typically last between one and two weeks. We also conduct trials where periodic visits are required, typically over longer periods.  Phase II-IV trials can last several months to several years.

14. What happens at a clinical trial screening? You are provided with information about the trial and a doctor take your medical history.  You may receive a health screening. If your health status matches the criteria for the trial, you will be given the option to participate.