Clinical trials have a critical role in bringing new and more effective drugs, devices and tests into our lives. However it may be difficult for patients to decide whether a specific clinical trial is right for them. It is easy to find reports in the media that may cause some to worry, but enrolling and participating in a clinical trial can be a positive experience. It is estimated that 20 million Americans enroll in clinical trials each year.
What Is a Clinical Trial?
Patients considering participation in a clinical trial should understand what a trial is, and what it is not, and make their decisions based upon a full appreciation of the facts. Important facts include information on specific requirements of participation, why the study is being done, and any incentives the researchers have for doing the clinical trial.
Clinical trials are "experiments" to test the effectiveness, and sometimes the safety, of new treatments or tests. They are not guaranteed to produce benefits for all participants, although they may be the only way to access such treatments at that time. The scientific design of clinical trials is required to be sure that the results, positive or negative, are acceptable to the medical community at large. Each patient must decide whether these methods meet their needs.
How a Clinical Trial Works
In a typical trial, the new treatment is compared to an existing treatment or perhaps no treatment at all. Participants may be assigned to a treatment group at random (like the flip of a coin) to be sure that the new treatment is fairly tested. The patient is not allowed to choose the group in which they will be assigned. So some participants may not get the new treatment, and those who do may not do better than those given the standard treatment. It is important to understand that the main purpose of the study is to measure the effectiveness and safety of the new treatment or device, and not to guarantee a personal benefit. When a patient decides to participate, he or she is deciding that the possibility of receiving the new treatment is worth the risk of not receiving any benefit.
There are many benefits to participation. The trial may be the only way to obtain new treatments early on, and the treatments and tests used to measure their effectiveness are usually provided at no cost. Participants often are evaluated more consistently through a course of treatment and may have greater access to doctors, nurses, and other healthcare professionals. The most significant benefit is to the general public, in helping doctors evaluate new treatments and make the best ones available to everyone more quickly.
What Are the risks?
It is also important to know that all clinical trials must conform to strict legal and ethical standards. At MemorialCare facilities, all studies must be reviewed, and approved by the MHS Institutional Review Board (IRB). This group of doctors, nurses, hospital leaders and community representatives must be satisfied that patients are fully protected, and that they are given all the facts about a clinical trial, before it is allowed to proceed.
Nevertheless, there is always some risk in participating in studies of new treatments. In many cases the risk is very small, such as bruising from having blood drawn or being embarrassed by sensitive questions, but sometimes serious side effects or worsening illness may occur. Patients must understand the risks of participating in a clinical trial and decide what level of risk is acceptable to them before they agree to enroll. Sometimes, participation may not be the best choice. And in some cases, patients will want to seek help from family, friends or a trusted physician before they agree to take part in a clinical study. The physician researcher always wants the patient to be comfortable with his or her decision. Little is gained if the patient enrolls only to quickly drop out — or not follow study procedures — because of second thoughts.
Important Questions to Ask
The informed patient always makes the best clinical trial participant. Questions that patients often ask, include the following:
- What is the actual purpose of this trial?
- What are the benefits of my participation?
- What are the risks?
- What are my responsibilities, if I agree to take part?
- How long will the study last?
- Will I, or my insurance carrier, have to pay for participating in the study?
- Who is sponsoring the study, and why?
- Will the information I provide, and my records, be kept confidential?
The answers to these, and similar questions, should assist in making the best decision on participating in a clinical trial.
For more information on clinical trials and your specific rights, we recommend the following sites: