Frequently Asked Questions
A clinical trial is also called a research study. Under the supervision of a medical doctor and other research professionals, volunteers receive investigational treatments. These investigational treatments are made by biotechnology and pharmaceutical companies. These companies work with qualified physicians, also referred to as investigators, to oversee clinical trials to establish the benefits of investigational drugs.
In a clinical trial, a participant is usually assigned to a study group. Participants in one study group may receive a placebo while other participants may receive an investigational treatment.
A placebo is defined as an inactive product used to evaluate the experimental treatment’s helpfulness. The participant, research staff, and physician may not know which participant receives a placebo and which receives the real treatment. Not knowing which volunteers are receiving the real treatment allows the research staff and physician to impartially observe the participants during the study. In spite of which treatment participants receive, however, the level of medical care and attention that they receive is the same.
This decision is entirely up to you. There are a number of reasons why people participate in a clinical study:
- Some participants have a medical diagnosis that is being managed effectively but wish to help scientists find out more about it so that new treatments can be developed.
- It is possible that there is not a current treatment for a particular disease, or that the existing treatment has difficult side effects. Volunteering in a clinical study could offer treatment options that may otherwise be unavailable.
- People sometimes choose to volunteer for a study even if it does not help them directly. For them, knowing that others could benefit from their efforts is rewarding.
Studies vary in length, depending on the phase and FDA requirements. We look at the timelines, established by the protocol our staff tries to be very flexible and accommodating while staying within the parameters or set up by the study.
Not necessarily. Clinical trials have rules about who can participate. A volunteer must first qualify for the clinical trial. The things that allow volunteers to take part in a clinical trial are called “inclusion criteria” and the things that disallow volunteers from taking part are called “exclusion criteria.” These criteria can include gender, age, previous treatment history, the type and stage of a disease, and other medical conditions. Some research studies look for participants with specific diseases to be studied, while other clinical trials require healthy people.
Research studies rarely have any fees beyond the basic standard of care (such as the need for a fistula or a graft) that participants normally receive as kidney disease patients. In fact, most studies and sponsors of the studies offer a small stipend for time and patient travel to the studies.
Clinical studies that are well-executed and well-designed are a good approach for eligible volunteers to:
- Have an active role in their health care.
- Obtain access to new treatments before they are available.
- Help other individuals by contributing to research
As with most treatments, there are possible risks to volunteering for a clinical study. These possible risks are:
- Participation may involve more time than routine care. This may include visits to the study location, frequent procedures or treatments, telephone calls from the study staff, answering questions, a possible hospital stay or a more complicated medication regimen.
- The study treatment may not work for every person.
- In some studies, there could be a possibility of unpleasant, serious – including life-threatening – side effects when undergoing investigational trials.
Side effects are defined as any undesired effect or action of the study medication or treatment. They can vary with each study.
Study treatments must be assessed for immediate, as well as long-term side effects.
All known potential side effects will be disclosed prior to participation.
People considering volunteering for a clinical trial should talk about it with their doctors and medical caregivers. Potential participants should also ask about the credentials and experience of the facility staff involved in conducting the clinical study.
Questions to ask a doctor or research staff:
- How long does the trial last?
- At what location(s) is the study being conducted?
- What types of treatments will be utilized and how?
- What is the purpose of the study?
- How will my safety be monitored?
- What are the risks involved?
- Are there any possible benefits?
- Are there alternative treatments other than the one being tested in the study?
- Who is the sponsor of the study?
- Do I personally have to pay for anything related to the study?
- What happens if I am hurt during the study?
- Can I choose to remain on the treatment, even after the study ends?
The legal and ethical codes that regulate medical practice also relate to clinical studies. Most research is federally controlled with safeguards to protect volunteers.
Every clinical study in the United States must be approved and supervised by an Institutional Review Board (IRB). The IRB ensures that risks to volunteers are as low as possible and are worth the possible benefits. An IRB is an independent group of community advocates, statisticians, physicians, and others that ensure a clinical study is ethical. The IRB also ensure that the rights of study volunteers are protected.
During a clinical trial, you will see the research study doctor. This doctor is a specialist in their field of study.
You will also see study staff. This team includes research nurses and research coordinators.
These studies do not provide for complete primary health care, so you will still need to see your primary care provider and a specialist.
Absolutely yes. You can leave a clinical study at any time. When leaving a study, you should let the research team know immediately, and be willing to discuss your reasons for leaving.