Clinical Research Studies
Current ERIB Studies  Enrolling in a clinical trial
Is enrolling in a clinical trial right for you? This depends on a number of factors, including your medical condition.
- Find out about clinical trials that are available for your condition.
- Carefully research the locations, treatments, and protocols for these medications.
- Contact a clinical trials site coordinator to get answers to specific questions below you may have about clinical trials.
Only you can decide whether enrolling in a clinical trial is the right decision for you and your family. Weigh the short- and long-term benefits against personal costs. Be sure you have all the facts and your questions have been answered to your satisfaction.
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Questions to Ask the Study Team
Before enrolling in a study, you should obtain answers to the following questions. If you cannot find answers to these questions on the consent form, ask the study investigator or coordinator.
Study Questions:
- What is the primary purpose of the study?
- Why do researchers believe the new treatment being tested may be effective? Has it been tested before? Where? And, if so, for how long?
- What is known about the medication’s effectiveness and safety in other countries?
- What are the possible risks, side effects, and benefits of the clinical trial, and how do they compare with my current treatment?
- Who will be participating in the study?
- What kinds of medical problems would prevent participation in the clinical trial?
Sponsor Questions:
- Who is sponsoring the study?
- What is the experience of the sponsor company? Are they a new company or do they have a long history with your condition?
- What is the likelihood of the company having the resources to obtain FDA approval and provide an adequate supply of the medication once it is approved?
- What other medications has the company studied and/or brought to market? What is the company’s track record?
Insurance and Reimbursement Questions
- Will I (or my health insurance company) have to pay for any part of the study?
- Should I inform my health insurance company before enrolling?
- What assistance will the sponsor company provide in terms of transportation or hotel accommodations?
- What medical tests, office visits, and treatment costs will be covered during the clinical trial?
Treatment Questions:Who will be in charge of my care?
- What type of screening is involved?
- How many times will I have to visit the study center and see the study doctor?
- If I have an episodic condition, when should I contact my physician? At the onset, or after a waiting period?
- What treatment(s) are involved?
- What if I miss a dose?
- Is there a chance I will be receiving a placebo instead of the new treatment? Will I know if I am receiving the placebo? Will my doctor?
- Will I receive medication even if I’m in the placebo group? What is the duration of time between receiving the placebo and receiving the treatment?
- Does the study allow for additional treatment dosages if the first dose does not bring you rapid relief?
- What does the protocol allow if I am having a painful or life-threatening attack?
- If I am currently taking other medications(s), should I continue taking these medications?
- How might this trial affect my daily life?
- How long will the trial last?
- Will hospitalization be required?
- What type of long-term follow up care is part of this study?
- How will I know that the treatment is working?
- How will my safety be monitored? What happens if the treatment causes me harm?
- Will results of the trials be provided to me? If so, when?
- Can I drop out of the study at any time?
- Can I choose to remain on this treatment, even after the trial ends?
Your Rights in a Clinical Trial
Most clinical research is federally regulated with built-in safeguards to protect your rights and safety.
- Each clinical trial follows a carefully controlled protocol (or study plan) that details what researchers will do in the study. As a clinical trial progresses, researchers report the results at scientific meetings, in medical journals, and to government agencies. Your name remains confidential and is not mentioned in these reports.
- All institutions that conduct human clinical trials must have an Institutional Review Board (IRB) that initially approves and periodically reviews the research. The purpose of the IRB is to make sure clinical research adheres to strict ethical guidelines and poses no unnecessary risks to participants.
- Anyone participating in US clinical trial has the right to informed consent. This process provides key information about the study in language that is easy to understand and guarantees the participant’s right to receive information throughout the course
of the trial.
- You cannot be enrolled in a clinical trial without your knowledge. Informed consent protects you from unauthorized research. Your privacy will be protected. Your name cannot be revealed, and your medical information must remain confidential.
- You always have the right to say “no,” if you are uncomfortable with what you are being asked to do or if you don't fully understand it. Because participation is voluntary, you can withdraw from a clinical trial at any time.
- You do NOT have to pay to participate in a clinical trial. Costs of routine tests and procedures that are part of your normal health care will be paid in accordance with the terms of your health insurance plan. This is one of the advantages of taking part in a clinical trial.
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Your Responsibilities
The study team will explain your responsibilities as a participant. Before signing the Consent Form:
Once the study is underway, your primary responsibilities are to stay in regular contact with your study center. Other responsibilities include:
- Contacting the study doctor as soon as possible in the event of an emergency or if you are hospitalized for any reason.
- Telling the study doctor about any side effects you think may be related to the medication.
- Letting your other doctors know you are participating in a clinical trial and providing them with contact information for study doctor if necessary.
- Keeping a diary, if requested, of your experiences with treatment.
Should you decide to withdraw from the study, let the study team know. In order to get FDA approval for a drug, it is important that volunteers complete the study, if possible, and be available for follow-up. |
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